EvaluateMedTech has used a number of sources within the site to develop a 4-level classification tree based on the FDA approvals process.

Size: px
Start display at page:

Download "EvaluateMedTech has used a number of sources within the site to develop a 4-level classification tree based on the FDA approvals process."

Transcription

1 Classification of Approvals from FDA Classification EvaluateMedTech has used a number of sources within the Devices@FDA site to develop a 4-level classification tree based on the FDA approvals process. The top level of the FDA Classification is based on the FDA Review Panel, Advisory Committee and Regulation Medical Specialty and consists of the following: Anesthesiology Devices Cardiovascular Devices Clinical Chemistry And Clinical Toxicology Devices Dental Devices Ear, Nose, And Throat Devices Gastroenterology-Urology Devices General And Plastic Surgery Devices General Hospital And Personal Use Devices Hematology And Pathology Devices Immunology And Microbiology Devices Neurological Devices Obstetrical And Gynecological Devices Ophthalmic Devices Orthopedic Devices Physical Medicine Devices Radiology Devices The 2 nd tier is based on the subpart of the Regulation Number classification system within which the Regulation Number (format ) falls. In most of the top level classifications this falls into five broad categories: Diagnostic Monitoring Prosthetic Surgical Therapeutic The 3 rd tier is based on the Regulation Number (format ) and its corresponding textual description. The 4 th tier is based on the Classification Product Code (format ABC) and its corresponding textual description. Example K is classified as: Level 1: Cardiovascular Devices (based on FDA Review Panel, Advisory Committee and Regulation Medical Specialty) Level 2: Cardiovascular Therapeutic Devices (based on the subpart of the Regulation Number classification system) Level 3: Embolectomy catheter (based on Regulation Number [Embolectomy catheter]) Level 4: Device, Percutaneous Retrieval (based on Classification Product Code MMX [Device, Percutaneous Retrieval]) Note: A number of approvals in Devices@FDA (both PMAs and 510-Ks) have no Regulation Number and/or Classification Product Code. In these instances the products are classified as Unclassified in the FDA Classification tree.

2 EvaluateMedTech Classification Overview In addition to the FDA Classification, EvaluateMedTech has created its own 3-level classification system for the products approved in It is based on the FDA Classification system but has been enhanced to bring products together into competitive groups which mirror the commercial view of the MedTech market. The EvaluateMedTech classification system endeavours to form a link between the companies revenues and the product approvals that they have received. As such, the FDA Classification tree was altered to provide a better fit with the way the companies report their segmental data. Each 4 th level of the FDA Classification tree is mapped to one of the 3 rd level tiers of the EvaluateMedTech Classification tree. Example Within the FDA Classification system there are 20 Level 4 classifications covering hip prostheses which cannot be grouped together at a higher level. The EvaluateMedTech groups all of these under one Level 3 Classification Hip Replacement. EvaluateMedTech Classification Details The notes below highlight how each of the EvaluateMedTech top level classifications differ from the FDA Classification tree: Anesthesia & Respiratory Renamed from FDA s Anesthesiology Devices to reflect inclusion of non-anaesthesia respiratory devices Blood Not present in the FDA Classification Includes: o Blood Collection Devices o Blood Filtration Devices (including Plasma Separators) o Blood Processing Devices o Blood Screening Devices o Blood Transfusion Devices Cardiology 2 nd level adjusted to better reflect the manner in which Cardiology companies report their segment revenues through creation of: o Cardiac Rhythm Management (CRM) o Electrophysiology o Interventional Cardiology Diabetic Care Not present in the FDA Classification Includes: o Glucose Test Systems (FDA classify in Clinical Chemistry And Clinical Toxicology Devices) o Insulin Pumps (FDA classify in General Hospital And Personal Use Devices) o Glycosylated Hemoglobin Assays (FDA classify in Hematology And Pathology Devices)

3 Diagnostic Imaging Not present in the FDA Classification at the top level FDA include within Radiology Includes: o Computed Tomography (CT) o MRI Systems o Nuclear Imaging Equipment o Ultrasound Systems o X-ray Systems o Other Diagnostic Imaging Drug Delivery Not present in the FDA Classification Includes devices used to deliver drugs and other fluids into the body FDA include within General Hospital And Personal Use Devices Ear, Nose & Throat (ENT) Split into: o Ear o Nose o Throat o General ENT (non-specific for one area) Endoscopy Not present in the FDA Classification at the top level Brings together all endoscope products and accessories from the different FDA top level classifications (e.g. Laparoscopes from Gastroenterology-Urology Devices and Arthroscopes from Orthopedic Devices) Gastroenterology Includes gastroenterology devices from the Gastroenterology-Urology Devices FDA Classification General And Plastic Surgery Devices Includes some surgical devices (e.g. biopsy devices, suction apparatus and adhesion barriers) from other FDA top level classifications, e.g.: o Gastroenterology-Urology Devices o General Hospital And Personal Use Devices o Obstetrical And Gynecological Devices General Hospital And Personal Use Devices Includes medical gloves, blood devices (e.g. transfusion apparatus) and hospital beds Healthcare IT Not present in the FDA Classification Includes Hospital and Patient Management Systems In Vitro Diagnostics Combination of the following FDA top level classifications: o Clinical Chemistry And Clinical Toxicology Devices o Hematology And Pathology Devices o Immunology And Microbiology Devices

4 EvaluateMedTech Classification 2 nd level split into: o Clinical Chemistry o Hematology o Histology & Cytology o Immunoassays o Microbiology o Molecular Diagnostics Haematology devices used in blood banking classified in Blood within EvaluateMedTech Classification system. Nephrology Not present in the FDA Classification Nephrology products contained within Gastroenterology-Urology Devices in the FDA Classification system EvaluateMedTech Classification 2 nd level split into: o Dialysis (3rd level: Hemodialysis and Peritoneal Dialysis) o Non-Dialysis Nephrology Devices Neurology Follows FDA Classification at 2 nd level Major 3 rd level classifications include: o Electroencephalographs o Neuromodulation Devices o Neurovascular Devices o Stereotaxic Instruments Obstetrics & Gynecology Follows FDA Classification at 2 nd level with the addition of Contraceptive Devices Ophthalmics Contact Lenses, Contact Lens Care and Eyewear in 2 nd level of EvaluateMedTech classification (included within Ophthalmic Therapeutic Devices in the FDA Classification) Orthopedics 2 nd level adjusted to better reflect the manner in which Orthopedic companies report their segment revenues through creation of: o Joint Reconstruction o Orthobiologics o Spinal Devices o Trauma Fixation Includes Cranioplasty and Cranial Orthosis products classified as Neurology by the FDA Patient Monitoring Not present in the FDA Classification Includes: o Blood pressure monitors o Oximeters o Stethoscopes o Thermometers o Other non-invasive monitoring equipment Physical Medicine Mobility Aid Devices created as a 2 nd level in the EvaluateMedTech classification to include wheelchairs and limb prostheses

5 Radiology Only includes radiological therapeutic devices in EvaluateMedTech Classification Radiological diagnostic devices removed to Diagnostic Imaging in EvaluateMedTech Classification Urology Includes urology devices from the Gastroenterology-Urology Devices FDA Classification Includes the following 2 nd level classifications: o Male Urology Devices o Other Urology Devices o Ureteral Devices o Urethral Devices o Urinary Incontinence Devices o Urological Catheters Wound Management Not present in the FDA Classification Includes those products involved in managing wounds which are found in the FDA classifications of Gastroenterology-Urology Devices and General And Plastic Surgery Devices Includes: o Compression Devices o Ostomy Devices o Wound Cleansing Systems o Wound Closure Devices o Wound Dressings o Wound Healing Devices

6 Consensus Forecasting One of the most powerful features of the EvaluateMedTech service is the Forecast Module. Evaluate Ltd has developed a reliable and consistent methodology to build segmental revenue splits, income statements, cash flow statements and balance sheets going into the future based on equity analysts' projections. This allows you to read the future as well as the past of the world's leading companies. Forecasts are updated monthly. The key steps carried out by EvaluateMedTech Analysts in developing each company's forecast are as follows: Collect forecasts of segment sales, costs and earnings per share forecasts published by equity analysts. Create a consensus forecast based on the average of recent forecasts. Monitor company financial releases to the investment community for information on key financial and operating drivers. These include such items as future cost structure (CoGS, S,G&A and R&D costs), capital expenditure, dividend and share-buyback policies, details of recent acquisitions and divestitures, expected corporate tax rates, corporate financial and operating targets and any other material developments. Build total company sales forecasts from consensus segment sales forecasts. Enter financial assumptions into the EvaluateMedTech model that builds each company's income statement, cash flow and balance sheet.

7 EvaluateMedTech Segmental Forecasting Primer Overview EvaluateMedTech provides a detailed overview of each company s segmental sales breakdown, both historic (back to 2005) and forecast (to 2018). Company disclosure of the segmental breakdown can be limited and EvaluateMedTech uses equity analysts historic estimates in conjunction with company reported figures to provide the greatest detail possible. For 2009 to 2011, fields are available within EvaluateMedTech which indicate whether the figure for each revenue line is either an Estimate (based on equity analyst figures) or an Actual (reported by the company). These revenue lines are displayed in the same way that the company and the equity analysts report and EvaluateMedTech attempts to take into consideration any restatements by the company so that historic years data is presented in the manner the company currently reports. The revenue lines are classified by EvaluateMedTech to one of three levels: Segment Sub-Total Total Revenue lines classified as Total are comprised of one or more Sub-Totals, which in turn are comprised of one or more Segments (subject to analyst/company disclosure). Balancing Items Because the level of disclosure by the equity analysts varies from analyst to analyst, the analysts reporting revenues for each of the Segments and the Sub-Totals are not always the same as those reporting the top level Totals. This can result in the sum of the Segments not being equal to the Sub-Total of which they are a part. Similarly, the sum of the Sub-Totals may not equal the Total of which they are a part. In order to rectify this, EvaluateMedTech has added a Balancing Item line which provides the balancing figure to bring the sum of the Segments back to the Sub-Total and the sum of the Sub-Totals back to the Total. In some cases it is worth noting that this can be negative if the analyst providing the greater breakdown is more bullish/optimistic than the consensus. Example In Johnson & Johnson four analysts forecast sales of General Surgery (one of JNJ s MedTech segments for which it reports revenues on an annual and quarterly basis). However, only one of these analysts provides a greater breakdown of this division into the following Sub-Total divisions: Sutures Endomechanical Hernia Women's Health Bands Wound Care/Other Because this one analyst is particularly optimistic about General Surgery compared to consensus, the sum of the Sub-Totals is greater than the consensus for General Surgery. This means that the Balancing Item added into General Surgery is a negative figure. Note: Balancing Items do not have Forecasters or Forecast Statistics.

8 EvaluateMedTech Classification In order to allow comparison of revenue lines across companies, EvaluateMedTech has classified each revenue line to a branch of the EvaluateMedTech classification tree. This is based on the classification of the products contained within the revenue line, thus providing a link between the company revenues and the Devices@FDA database. Where possible the revenue line has been classified to the 3 rd level of the EvaluateMedTech classification tree. However, in some cases this has not been possible as the revenue line contains too diverse a line of products. In these cases the revenue line is classified to the 1 st or 2 nd levels if possible. However, in some instances a revenue line is too broad for classification to any level of the EvaluateMedTech classification tree (e.g. it contains an equal number of Cardiology and Respiratory products). In these cases the revenue line is classified as Unclassified Medical Devices. For revenue lines which do not relate to end-user sales of MedTech products then the revenue line is classified as Unclassified. EvaluateMedTech Totals For each of the 1 st and 2 nd levels of the EvaluateMedTech tree a Total Market has been added (e.g. Orthopedics Total Market or Joint Reconstruction Total Market). These represent the total sales of that company in that field by aggregating the revenues for all the segments which constitute that field. As the way companies report does not always fit neatly with the EvaluateMedTech Classification tree EvaluateMedTech Totals have been added as additional revenue lines in the segment model for each company. Example Equity analysts for Johnson & Johnson provide sales figures for the following segments of the company s DePuy division: DePuy - Hips DePuy - Knees Extremities DePuy Spine DePuy Mitek/ Orthovisc (Sports Medicine) Trauma Maxillofacial Codman & Shurtleff (Global Neuroscience)Endoscopy Other Depuy All of the above segments are classified as Orthopedic at the 1st level of the EvaluateMedTech classification tree except Codman & Shurtleff, which is classified as Neurology. Because of this the total DePuy sales cannot be classified as Orthopedic Total Market at the 3 rd level. However, an entry in Johnson & Johnson needs to be classified as Orthopedic Total Market so that it appears on the Orthopedic summary page with the Total Market figures for the other companies. EvaluateMedTech has therefore created an EvaluateMedTech Total which provides a sum of all DePuy segments excluding Codman & Shurtleff. These EvaluateMedTech Totals are excluded from the pre-defined reports on the company summary pages as these reports aim to display the companies revenues as the company reports them. They are, however, displayed on other summary pages looking across companies at a specific level of the EvaluateMedTech classification tree.

9 These revenue lines are classified as EM Total in the Division Type field. EM Totals will not have Forecasters and Forecast Statistics if they consist of an aggregation of consensus revenue lines generated from different sets of equity analysts. Total Company Revenues Each company also has an entry for each of the following: MedTech Sales (End-user MedTech revenues) MedTech Other Revenues (Non-end-user revenues, e.g. royalties, co-promotion revenues, service revenues) Total MedTech Revenues Non-MedTech Revenues Total Company Sales IS/MFS 27/09/12

CommitteeName_txt. Abuse Advisory Committee. Ad Hoc Committee on In Vitro Screening Devices. Advisory Committee of Immunization Practices (ACIP)

CommitteeName_txt. Abuse Advisory Committee. Ad Hoc Committee on In Vitro Screening Devices. Advisory Committee of Immunization Practices (ACIP) Abuse Advisory Committee Ad Hoc Committee on In Vitro Screening Devices Advisory Committee of Immunization Practices (ACIP) Advisory Committee on Special Studies Relating to the Possible Long-Term Health

More information

MEDICAL DEVICES: TECHNOLOGIES AND GLOBAL MARKETS

MEDICAL DEVICES: TECHNOLOGIES AND GLOBAL MARKETS MEDICAL DEVICES: TECHNOLOGIES AND GLOBAL MARKETS HLC170B January 2017 Vijay Laxmi Project Analyst ISBN: 1-62296-410-1 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215 (toll-free

More information

Medidée Services SA. Nano-Tera.ch. 05 February 2015 part 8. PMA, 510k, IDE. Pierre-Alain Sommer

Medidée Services SA. Nano-Tera.ch. 05 February 2015 part 8. PMA, 510k, IDE. Pierre-Alain Sommer Nano-Tera.ch 05 February 2015 part 8 PMA, 510k, IDE Pierre-Alain Sommer Pierre-alain.sommer@medidee.com www.medidee.com Nano-Tera 2015 05.02.2015 USA/FDA Pre Market Approval System - PMA, Pre Market Notifcation

More information

APPROVED BY: CURRICULUM MASTER S DEGREE MEDICAL DOCTOR THE COMPLETE COURSE OF EDUCATION LASTS FOR 6 YEARS

APPROVED BY: CURRICULUM MASTER S DEGREE MEDICAL DOCTOR THE COMPLETE COURSE OF EDUCATION LASTS FOR 6 YEARS I II III IV V VI Academic Year 2017/18 for all courses APPROVED BY: CURRICULUM MASTER S DEGREE MEDICAL DOCTOR THE COMPLETE COURSE OF EDUCATION LASTS FOR 6 YEARS EXAMS DURING SEMESTER HOURS DISTRIBUTION

More information

3.5. Review of Medical Device Study. Table of Contents

3.5. Review of Medical Device Study. Table of Contents Page 1 of 14 Table of Contents No. Content Page No. Table of Contents...... 1 1. Purpose.. 2 2. Scope. 2 3. Responsibility... 2 4. Flowchart... 3 5. Detailed Instruction... 4 5.1 Receipt of submitted documents..

More information

Global Endoscopy Market Report

Global Endoscopy Market Report Global Endoscopy Market Report ----------------------------------------- 2014 View Report Details Executive Summary Endoscopy is a minimally invasive diagnostic medical procedure in which a tube like instrument,

More information

PHARMA/MEDICAL DEVICE COMPANIES

PHARMA/MEDICAL DEVICE COMPANIES PHARMA/MEDICAL DEVICE COMPANIES Company Information Company Division of Address City State Zip Phone Fax Web Email Company Services Provided please keep description brief (50 words or less) and factual:

More information

Iran's Capabilities in the field of Medical Equipment. Dr.Mahmoud Biglar. General Director Medical Devices Department Food and Drug Organization

Iran's Capabilities in the field of Medical Equipment. Dr.Mahmoud Biglar. General Director Medical Devices Department Food and Drug Organization Iran's Capabilities in the field of Medical Equipment Dr.Mahmoud Biglar General Director Medical Devices Department Food and Drug Organization Overview: Medical Equipment Department, Aims & Mission Imports,

More information

Medical Electronic Devices

Medical Electronic Devices Medical Electronic Devices Basic Electronics (Electronic devices, Amplifiers, A/D, D/A) Electrodes EEG Deep brain stimulator ECG Cardiac Pacemakers External Defibrillators EMG Neuromuscular Electrical

More information

EY Life Sciences. Key themes from The Next Frontiers in Precision Medicine panel. February 2016

EY Life Sciences. Key themes from The Next Frontiers in Precision Medicine panel. February 2016 EY Life Sciences Key themes from The Next Frontiers in Precision Medicine panel February 2016 Evolution of precision medicine One-size-fits-all therapeutics Precision medicine Disconnected health care

More information

Teleflex Incorporated (NYSE: TFX) Investor Presentation

Teleflex Incorporated (NYSE: TFX) Investor Presentation Teleflex Incorporated (NYSE: TFX) Investor Presentation Important Information 2 Forward Looking Statements This presentation and our discussion contain forward-looking information and statements, which

More information

3rd Global Congress On Medical & Clinical Case Reports Theme: Medical & Clinical Exploration By Global Experts About the Conference: Aim

3rd Global Congress On Medical & Clinical Case Reports Theme: Medical & Clinical Exploration By Global Experts About the Conference: Aim 3rd Global Congress On Medical & Clinical Case Reports Theme: Medical & Clinical Exploration By Global Experts About the Conference: Gavin Conferences invites participants from all over the world to attend

More information

The European Medical Technology Industry. in figures / 2018

The European Medical Technology Industry. in figures / 2018 The European Medical Technology Industry in figures / 2018 Table of contents What is Medical Technology? 4 Innovation 10 Employment 14 Companies 18 Expenditure on Medical Technology 20 MedTech Market in

More information

Market Circumstances of Medical Device Industry and Logic for Building a Strategy for Innovation by Japanese Companies

Market Circumstances of Medical Device Industry and Logic for Building a Strategy for Innovation by Japanese Companies No.259-1 (Jun 17, 216) Market Circumstances of Medical Device Industry and Logic for Building a Strategy for Innovation by Japanese Companies 1. Levels of total healthcare expenditure for Japan, the U.S.

More information

MANAGEMENT SCIENCE doi /mnsc ec

MANAGEMENT SCIENCE doi /mnsc ec MANAGEMENT SCIENCE doi 10.187/mnsc.1090.1017ec e-companion ONLY AVAILABLE IN ELECTRONIC FORM informs 009 INFORMS Electronic Companion Business Unit Reorganization and Innovation in New Product Markets

More information

The European Medical Technology Industry in figures

The European Medical Technology Industry in figures The European Medical Technology Industry in figures Table of contents What is Medical Technology? 4 Innovation 10 Employment 14 Companies 18 Expenditure on Medical Technology 20 MedTech Market in Europe

More information

Field Categories Frascati Manual. Mathematics

Field Categories Frascati Manual. Mathematics Algebra and Number Theory Natural Sciences Mathematics Computer and Information Sciences Physical Sciences Analysis Applied Mathematics Computational Mathematics Control and Optimization Discrete Mathematics

More information

MEDIAN IMPACT FACTOR 2010 (ISI 2011) - SCIENCE

MEDIAN IMPACT FACTOR 2010 (ISI 2011) - SCIENCE MEDIAN IMPACT FACTOR 2010 (ISI 2011) - SCIENCE Median Impact Factor Aggregate Immediacy Index Aggregate Cited Half- Life # Journals Articles Category Total Cites Aggregate Impact Factor ACOUSTICS 93121

More information

China-EU Competition Week: Abbott's Acquisition of St. Jude Medical

China-EU Competition Week: Abbott's Acquisition of St. Jude Medical China-EU Competition Week: Abbott's Acquisition of St. Jude Medical Anti-monopoly Bureau, MOFCOM Tang Yu March 2017 Part I: basic information of the case Part II: definition of relevant markets and competitive

More information

Disposable Medical Supplies

Disposable Medical Supplies Disposable Medical Supplies US Industry Study with Forecasts to 2007 & 2012 STUDY #1696 August 2003 $4200 The Freedonia Group www.freedoniagroup.com The First Choice In Industry Research 767 Beta Drive

More information

Median Impact Factor : (from JCR Science Edition : Year ٢٠٠٧)

Median Impact Factor : (from JCR Science Edition : Year ٢٠٠٧) Median Impact Factor : (from JCR Science Edition : Year ٢٠٠٧) No. Subject Category Total Cites Median IF Aggregate IF # Journals Articles ١ Acoustics ٧١۵٩۵ ٠ ٧٣٨ ١ ٢۴٩ ٢٨ ٣۶٩١ ٢ Agricultural Economics

More information

Category Median Aggregate Aggregate Aggregate. Factor Factor Index Half-Life

Category Median Aggregate Aggregate Aggregate. Factor Factor Index Half-Life Category Median Aggregate Aggregate Aggregate Rank (linked to category information) Total Cites Impact Impact Immediacy Cited # Journals Articles Factor Factor Index Half-Life 1 ACOUSTICS 98897 1.036 1.548

More information

Print Journals List. The American Biology Teacher Online: Oct 1938 (v. 1, n.1) May 2011 (v. 73, n. 5)

Print Journals List. The American Biology Teacher Online: Oct 1938 (v. 1, n.1) May 2011 (v. 73, n. 5) Print Journals List AACN: Advanced Critical Care (formerly AACN Clinical Issues) On Shelf: Jan/Mar 2008 (v. 19, n. 1) Jan/Mar 2011 (v. 22, n. 1) AAOHN: American Association of Occupational Health Nursing

More information

FDA. Design of Biomedical Devices and Systems, 2nd Edition, King & Fries, CRC Press, 2009.

FDA.  Design of Biomedical Devices and Systems, 2nd Edition, King & Fries, CRC Press, 2009. FDA www.fda.gov Design of Biomedical Devices and Systems, 2nd Edition, King & Fries, CRC Press, 2009. ABOUT US FDA's Mission Statement The FDA is responsible for protecting the public health by assuring

More information

۱۵ BIOCHEMISTRY & MOLECULAR BIOLOGY

۱۵ BIOCHEMISTRY & MOLECULAR BIOLOGY MIF ۲ ۰ ۱ ۰ Science Edition Rank Category (linked to category information) Total Cites Median Impact Factor Aggreg ate Impact Factor Aggregate Immediac y Index Aggregat e Cited Half-Life # Journal s Article

More information

Categories Data Filtered by: Selected JCR Year: 2015 Selected Editions: SCIE. Category

Categories Data Filtered by: Selected JCR Year: 2015 Selected Editions: SCIE. Category Categories Data Filtered by: Selected JCR Year: 2015 Selected Editions: SCIE Category Edition # Journals Total Cites Median Impact Factor Aggregate Impact Factor ACOUSTICS SCIE 32 138,295 1.103 1.852 AGRICULTURAL

More information

U.S. Census Bureau Electromedical Equipment and Analytical Instruments MA334A(10) Issued July 2011

U.S. Census Bureau Electromedical Equipment and Analytical Instruments MA334A(10) Issued July 2011 U.S. Census Bureau Electromedical Equipment and Analytical Instruments - 2010 MA334A(10) Issued July 2011 Address inquiries concerning these data to Investment Goods Industries Branch, U.S. Department

More information

Evaluate Data Kit Pharma, Biotech and Medtech, May 2018

Evaluate Data Kit Pharma, Biotech and Medtech, May 2018 Evaluate Data Kit Pharma, Biotech and Medtech, May 2018 Contents Introduction 2 Sourcing Instructions / About Evaluate 3 Section 1 Pharma Industry Overview Top 15 Rx and OTC Sales 4 WW Rx and OTC Sales

More information

Supply Chain Congress 21 August 2013 Megan Main, Chief Executive

Supply Chain Congress 21 August 2013 Megan Main, Chief Executive Reforming the health supply chain down under Supply Chain Congress 21 August 2013 Megan Main, Chief Executive Health Purchasing Victoria (HPV) 1. HPV overview 2. Becoming more strategic 3. Global trends

More information

The Review Section Table (Overview)

The Review Section Table (Overview) Broad Section A Broad Section A (continued) Medium-sized Section 1:Philosophy, art, Medium-sized Section 5 :Law 01010 Philosophy and ethics-related 05010 Legal theory and history-related 01020 Chinese

More information

Mapping between Web of Science categories and 54 academic subjects

Mapping between Web of Science categories and 54 academic subjects Mapping between Web of Science categories and 54 academic subjects Academic Subjects Mathematics Mathematics Ecology Ecology Oceanography Atmospheric Science Mechanical Engineering Mechanical Engineering

More information

AJN: American Journal of Nursing On Shelf: Jan 2011 (v. 111, n. 1) Jan 2016 (v. 116, n. 1) Online: Oct 1900 (v. 1, n. 1) present

AJN: American Journal of Nursing On Shelf: Jan 2011 (v. 111, n. 1) Jan 2016 (v. 116, n. 1) Online: Oct 1900 (v. 1, n. 1) present Print Journals List AAOHN: American Association of Occupational Health Nursing (now Workplace Health and Safety) On Shelf: Jan 2011 (v. 59, Dec 2011 (v. 59, n. 12) Online: Jan 2003 (v. 51, Dec 2010 (v.

More information

Citations per Publication vs Publication Year. Year range 2009 to 2016 no subject area filter selected

Citations per Publication vs Publication Year. Year range 2009 to 2016 no subject area filter selected Data set Citations per Publication vs Publication Year Entities Archeology (arts and humanities), Arts and Humanities (miscellaneous), Classics, Conservation, General Arts and Year range 2009 to 2016 Filtered

More information

Integration in Hybrid Operating Rooms

Integration in Hybrid Operating Rooms Integration in Hybrid Operating Rooms Devising Optimal Clinical Environments At KARL STORZ we believe in order to perfect surgical outcomes within the operating theater, the technology in place should

More information

Appendix 1 Canadian Standards Association Standards for Equipment

Appendix 1 Canadian Standards Association Standards for Equipment Can J Anesth/J Can Anesth (2018) Appendix 1 Canadian Standards Association Standards for Equipment Legend Example: C22.2 NO. 0.1-FM85 (C1999) F Indicates the standard is written in French. M Indicates

More information

Global IVD Market

Global IVD Market Global IVD Market ----------------------------------------------------- 2014 Executive Summary An in-vitro diagnostic test is performed outside of a human body in an artificial environment (e.g. laboratory).

More information

FDA Regulation and Risk Assessment of Medical Devices

FDA Regulation and Risk Assessment of Medical Devices FDA Regulation and Risk Assessment of Medical Devices IOM Workshop on the Certification of Personal Protective Technologies April 13, 2010 Markham C. Luke, MD PhD Deputy Office Director & Chief Medical

More information

Insights from the operating room: does robotics change the established protocols for developing nextgeneration

Insights from the operating room: does robotics change the established protocols for developing nextgeneration Insights from the operating room: does robotics change the established protocols for developing nextgeneration surgical instruments? Effective requirements capture is critical for successful product development

More information

RE: Docket No. FDA 2017 N 0041: Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case

RE: Docket No. FDA 2017 N 0041: Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case 701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers

More information

IMDRF Working Group Improving the Quality of International Standards for Regulatory Use

IMDRF Working Group Improving the Quality of International Standards for Regulatory Use IMDRF Working Group Improving the Quality of International Standards for Regulatory Use Progress Report Dr. Matthias Neumann, Lead Federal Ministry of Health, Germany IMDRF 11 14 March 2017 Vancouver,

More information

Urodynamic Measurement System

Urodynamic Measurement System ID name description 1 CO2 Monitor Bedside carbon dioxide respiratory monitors. 2 Breathing Monitor Bedside monitors for continuous measurement of carbon dioxide and/or oxygen. 3 Electrohydraulic Lithotripter

More information

DME REGIONAL Carrier. DME REGIONAL Carrier. service (not separately payable). If other. DME REGIONAL Carrier. DME REGIONAL Carrier

DME REGIONAL Carrier. DME REGIONAL Carrier. service (not separately payable). If other. DME REGIONAL Carrier. DME REGIONAL Carrier A0021 - A0999 Ambulance Services Local Carrier A4206 - A4209 Medical, Surgical, and Self- Local Carrier if incident to a physician s Administered Injection Supplies A4210 Needle Free Injection Device A4211

More information

Certified Coder Boot Camp Original

Certified Coder Boot Camp Original *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview The premier CPC exam preparation course for coders The demand for CPC-certified coders has never been higher. If

More information

Certified Coder Boot Camp Original

Certified Coder Boot Camp Original *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview The premier CPC exam preparation course for coders The demand for CPC-certified coders has never been higher. If

More information

Acquisition of Polymer Technology Group

Acquisition of Polymer Technology Group 0 Acquisition of Polymer Technology Group 28 April 2008 Materials that belong to the body DSM Obtains a Leading Position in Biomedical Materials 0 Safe Harbor Statement 1 This presentation contains forward-looking

More information

DSM Biomedical. Materials that belong to the body. Steve Hartig President DSM Biomedical

DSM Biomedical. Materials that belong to the body. Steve Hartig President DSM Biomedical DSM Biomedical Materials that belong to the body Steve Hartig President DSM Biomedical Safe Harbor Statement This presentation may contain forward-looking statements with respect to DSM s future (financial)

More information

Anika Therapeutics, Inc.

Anika Therapeutics, Inc. Anika Therapeutics, Inc. Jefferies Global Healthcare Conference June 4, 2015 Safe Harbor Statement The statements made in this presentation that are not statements of historical fact are forward looking

More information

Global Spine Market Report

Global Spine Market Report Global Spine Market Report ----------------------------------------- 2014 Executive Summary Spine market is the largest segment of the global orthopedic industry. Spine disorders are categorized in four

More information

Medical Device Sourcing

Medical Device Sourcing Greystone Research Associates 1+603-595-4340 November 2015 Medical Device Sourcing The China Market Contents Report Scope & Overview 2 Table of Contents 3 Report Summary 4 Methodology 5 How to Order 6

More information

Health Sector Supplier Briefing

Health Sector Supplier Briefing Health Sector Supplier Briefing 1 Pre-briefing Survey Feedback Would it be helpful to cover roles and responsibilities in the Briefing? 2 Survey Themes Collaboration, consolidation, alignment and coordination

More information

CHAPTER 1. Survey of Clinical Cases of Biomaterials-Tissue Interactions: The Paradigm

CHAPTER 1. Survey of Clinical Cases of Biomaterials-Tissue Interactions: The Paradigm CHAPTER 1 Survey of Clinical Cases of Biomaterials-Tissue Interactions: The Paradigm 1.1 Introduction 1.2 Genotype/Phenotype (Fig. 1.1) 1.3 The Working Paradigm: The Unit Cell Process/The Control Volume

More information

Transform Olympus Transforming into a Truly Global Medical Technology Company Olympus Corporation January 11, 2019

Transform Olympus Transforming into a Truly Global Medical Technology Company Olympus Corporation January 11, 2019 Transform Olympus Transforming into a Truly Global Medical Technology Company Olympus Corporation January 11, 2019 Disclaimers The financial forecasts and other material in this document are based on judgements

More information

SciTechnol Mediakit. MatheMatics. Research and Reports on. Research Journal of Clinical Pediatrics

SciTechnol Mediakit. MatheMatics. Research and Reports on. Research Journal of Clinical Pediatrics SciTechnol Mediakit Research Journal of Clinical Pediatrics Research and Reports on MatheMatics www.scitechnol.com www.scitechnol.com Our Vision To publish, promote and disseminate the work of medical

More information

ADDIS ABABA UNIVERSITY CENTER OF BIOMEDICAL ENGINEERING

ADDIS ABABA UNIVERSITY CENTER OF BIOMEDICAL ENGINEERING ADDIS ABABA UNIVERSITY CENTER OF BIOMEDICAL ENGINEERING November 2013 History of Biomedical Engineering Definition of Biomedical Engineering Achievements of Biomedical Engineering Streams in Biomedical

More information

STRYKER ANALYST MEETING. September 2014

STRYKER ANALYST MEETING. September 2014 STRYKER ANALYST MEETING September 2014 FORWARD LOOKING STATEMENT Certain statements made in the presentation may contain information that includes or is based on forward-looking statements within the meaning

More information

RSNA 2016 Media Breakfast. Restricted Siemens Healthcare GmbH, 2016 Unrestricted Siemens Healthcare GmbH, 2016

RSNA 2016 Media Breakfast. Restricted Siemens Healthcare GmbH, 2016 Unrestricted Siemens Healthcare GmbH, 2016 RSNA 2016 Media Breakfast Restricted Siemens Healthcare GmbH, 2016 Unrestricted Siemens Healthcare GmbH, 2016 Disclaimer DISCLAIMER This document constitutes neither an offer to sell nor a solicitation

More information

Teleflex Incorporated Company Overview NYSE: TFX

Teleflex Incorporated Company Overview NYSE: TFX Teleflex Incorporated Company Overview NYSE: TFX Forward Looking Statements 2 This presentation and our discussion contain forward-looking information and statements including, but not limited to, long-term

More information

Research Involving FDA Regulated Devices Policy 606 Version: 1.1 POLICY

Research Involving FDA Regulated Devices Policy 606 Version: 1.1 POLICY POLICY 1. Purpose Outline the responsibilities and regulatory requirements when conducting human subject research that involves the use of devices under the oversight of the Food and Drug Administration

More information

New Advances in ECM:

New Advances in ECM: New Advances in ECM: How content management is transforming HIM practices Dan Stober Solution Consultant Recall Healthcare IT Challenges One EMR was supposed to be enough Is everything really in the EMR?

More information

Attachment A: 2019 Jurisdiction List for DMEPOS HCPCS Codes

Attachment A: 2019 Jurisdiction List for DMEPOS HCPCS Codes A0021 - A0999 Ambulance Services Part B MAC A4206 - A4209 Medical, Surgical, and Self- Part B MAC if incident to a physician's Administered Injection Supplies A4210 Needle Free Injection Device A4211 Medical,

More information

Safe Harbor Statement

Safe Harbor Statement Safe Harbor Statement This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of

More information

Progress Report. Jouko Karvinen CEO of Medical Systems

Progress Report. Jouko Karvinen CEO of Medical Systems Progress Report Jouko Karvinen CEO of Medical Systems Forward Looking Statements Forward Looking Statements This document contains certain forward-looking statements with respect to the financial condition,

More information

Radiography Curriculum Analysis

Radiography Curriculum Analysis Program Number Program Name Date / /20 Radiography Curriculum Analysis DIRECTIONS: Determine the course(s) in which each of the following content area is covered and enter the course number(s) and/or title(s).

More information

INVESTIGATIONAL DEVICES & DRUGS. What is an IRB to do?

INVESTIGATIONAL DEVICES & DRUGS. What is an IRB to do? INVESTIGATIONAL DEVICES & DRUGS What is an IRB to do? What is a medical device? An instrument, apparatus, implement, machine, contrivance, implant, or in vitro diagnostic reagent Recognized in the official

More information

Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

Request for Nominations for Individuals and Consumer Organizations for Advisory Committees This document is scheduled to be published in the Federal Register on 10/01/2015 and available online at http://federalregister.gov/a/2015-24835, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN

More information

3rd International Conference on Surgery and Medicine Theme: Emerging Technologies & Advanced Practices in Surgery

3rd International Conference on Surgery and Medicine Theme: Emerging Technologies & Advanced Practices in Surgery 3rd International Conference on Surgery and Medicine Theme: Emerging Technologies & Advanced Practices in Surgery Gavin Conferences invites participants from all over the world to attend 3rd International

More information

U.S. Medical Devices Market Outlook N1A5-54.

U.S. Medical Devices Market Outlook N1A5-54. U.S. Medical Devices Market Outlook N1A5-54 www.frost.com Frost & Sullivan takes no responsibility for any incorrect information supplied to us by manufacturers or users. Quantitative market information

More information

Medical Engineering (Biomedical Engineering, Clinical Engineering, Bioengineering) Medical Materials Science (Biomaterials) Dental Materials Science

Medical Engineering (Biomedical Engineering, Clinical Engineering, Bioengineering) Medical Materials Science (Biomaterials) Dental Materials Science Studying Medicine & Dentistry at University Technical Alternatives to Medicine & Dentistry Dr Martin Knight School of Engineering and Materials Science Why do you want to study Dentistry or Medicine? Good

More information

Analysis of the U.S. Medical Ultrasound Imaging Systems Market

Analysis of the U.S. Medical Ultrasound Imaging Systems Market MEDICAL DEVICES PHARMACEUTICALS CHEMICALS FOOD & BEVERAGE ELECTRONICS Analysis of the U.S. Medical Ultrasound Imaging Systems Market VPG Publications, Consulting, Clients www.vpgcorp.com VPG Market Research

More information

QUADRA FAMILY OF MEDICAL POLYURETHANES POLYMER SOLUTIONS FOR THE HEALTHCARE MARKET

QUADRA FAMILY OF MEDICAL POLYURETHANES POLYMER SOLUTIONS FOR THE HEALTHCARE MARKET QUADRA FAMILY OF MEDICAL POLYURETHANES POLYMER SOLUTIONS FOR THE HEALTHCARE MARKET Applications Biomerics is an innovative, polymer solution provider to the medical device and biotech industries. We specialize

More information

JURISDICTION LIST FOR DMEPOS HCPCS CODES

JURISDICTION LIST FOR DMEPOS HCPCS CODES JURISDICTION LIST FOR DMEPOS HCPCS CODES Deleted codes are valid for dates of service on or before the date of deletion. JURISDICTIONS B & C The jurisdiction list includes codes that are not payable by

More information

Lancashire Procurement Cluster November 2017

Lancashire Procurement Cluster November 2017 Lancashire Cluster November 2017 The Lancashire Cluster is the new shared collaborative procurement and supply chain service for: Blackpool Teaching Hospitals NHS Foundation Trust; East Lancashire NHS

More information

ISTINYE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF MEDICINE (ENGLISH) COURSE DESCRIPTIONS

ISTINYE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF MEDICINE (ENGLISH) COURSE DESCRIPTIONS ISTINYE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF MEDICINE (ENGLISH) COURSE DESCRIPTIONS Istinye University, Faculty of Medicine has two separate education programs as Turkish and English Medicine.

More information

Global In-Vitro Diagnostic Market Report

Global In-Vitro Diagnostic Market Report Global In-Vitro Diagnostic Market Report ----------------------------------------------------- 2013 Executive Summary The process of performing a diagnostic test outside of a living organism in an artificial

More information

US regulations. Tom Ståhlberg FiHTA

US regulations. Tom Ståhlberg FiHTA US regulations Tom Ståhlberg 20.3.2013 FiHTA Where do you want to be? Do you? US FDA US FDA and the rest of the world US FDA in general (Design control in general) (Design control elements) Regulation

More information

Advancing minimally invasive. therapeutics through novel device. development. Minima y Invasive New Technologies T H E L E O N A M. A N D H A R R Y B.

Advancing minimally invasive. therapeutics through novel device. development. Minima y Invasive New Technologies T H E L E O N A M. A N D H A R R Y B. MIN T Minima y Invasive New Technologies Advancing minimally invasive therapeutics through novel device development T H E L E O N A M. A N D H A R R Y B. C H A R I T A B L E T R U S T he Minimally Invasive

More information

GLOBAL DISPOSABLE MEDICAL DEVICES SENSORS MARKET

GLOBAL DISPOSABLE MEDICAL DEVICES SENSORS MARKET GLOBAL DISPOSABLE MEDICAL DEVICES SENSORS MARKET By Type [Biosensor, Image Sensor, Accelerometer] Monitoring [Smart Pill, Pulse Oximeter] Diagnostic [Capsule Endoscope, Blood Glucose Strip] Therapeutic

More information

Food and Drug Administration Modernization Act of 1997: Modifications to the List of

Food and Drug Administration Modernization Act of 1997: Modifications to the List of This document is scheduled to be published in the Federal Register on 01/14/2014 and available online at http://federalregister.gov/a/2014-00477, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN

More information

Rotations Lauren Slater, Trainee Healthcare Scientist (Medical Physics), Newcastle Upon Tyne Hospitals NHS Trust

Rotations Lauren Slater, Trainee Healthcare Scientist (Medical Physics), Newcastle Upon Tyne Hospitals NHS Trust Rotations Lauren Slater, Trainee Healthcare Scientist (Medical Physics), Newcastle Upon Tyne Hospitals NHS Trust www.nshcs.hee.nhs.uk @NSHCS @NHS_HealthEdEng Medical Physics Imaging with Ionising Radiation

More information

Safe Harbor Statement

Safe Harbor Statement Safe Harbor Statement This presentation may contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of

More information

Strength and opportunity 2011

Strength and opportunity 2011 Strength and opportunity 2011 The landscape of the medical technology, medical biotechnology, industrial biotechnology and pharmaceutical sectors in the UK Annual Update December 2011 This is the third

More information

Skills Standards SURGICAL TECHNOLOGIST OD38621 ALIGNS WITH AST ASSOCIATION OF SURGICAL TECHNOLOGISTS

Skills Standards SURGICAL TECHNOLOGIST OD38621 ALIGNS WITH AST ASSOCIATION OF SURGICAL TECHNOLOGISTS Skills Standards SURGICAL TECHNOLOGIST OD38621 ALIGNS WITH AST ASSOCIATION OF SURGICAL TECHNOLOGISTS COMPETENCY-BASED EDUCATION: OKLAHOMA S RECIPE FOR SUCCESS BY THE INDUSTRY FOR THE INDUSTRY Oklahoma

More information

Notification of a Body in the framework of a technical harmonization directive

Notification of a Body in the framework of a technical harmonization directive Notification of a Body in the framework of a technical harmonization directive From : Department of Health Medicines and Healthcare Products Regulatory Agency (MHRA) 151 Buckingham Palace Road, Victoria,

More information

Market Research at the NCBiotech Library

Market Research at the NCBiotech Library Market Research at the NCBiotech Library The library's subscriptions include selected reports from BCC Research and Kalorama Information. Abstracts and Tables of Contents are freely available online from

More information

Diagnosis for Open Wounds as a Result of Cancer Resection

Diagnosis for Open Wounds as a Result of Cancer Resection Diagnosis for Open Wounds as a Result of Cancer Resection December 15, 2016 What diagnosis code do we use when we are reconstructing a defect after the Moh s surgeon, or someone else removed the cancer?

More information

MEMBERSHIP APPLICATION FORM

MEMBERSHIP APPLICATION FORM PERSATUAN PERALATAN PERUBATAN MALAYSIA (MALAYSIA MEDICAL DEVICE ASSOCIATION) (0596-05-7) MMDA Secretariat Suite A-807, Level 8 Block A, Kelana Square No: 17, Jalan SS7/26, Kelana Jaya 47301 Petaling Jaya,

More information

Classification of MDs under the European MDR. Joachim Makowski. Joachim Makowski, MED-RAS GmbH, a partner to confinis ag

Classification of MDs under the European MDR. Joachim Makowski. Joachim Makowski, MED-RAS GmbH, a partner to confinis ag Classification of MDs under the European MDR Joachim Makowski 1 Table of content MDR references Context of classification Key changes Actions required 2 3 Context of classification Context of classification

More information

1161 Sawgrass Corp. Pkwy, Sunrise, FL of 6

1161 Sawgrass Corp. Pkwy, Sunrise, FL of 6 TAG3 was founded by three industry experts with a vision to offer cost-effective, streamlined medical device product design, development, quality and regulatory affairs solutions to organizations of all

More information

Jefferies London Healthcare Conference Julie Brown, CFO

Jefferies London Healthcare Conference Julie Brown, CFO Jefferies London Healthcare Conference Julie Brown, CFO Forward looking statements This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding

More information

Teleflex Incorporated Company Overview NYSE: TFX

Teleflex Incorporated Company Overview NYSE: TFX Teleflex Incorporated Company Overview NYSE: TFX Forward Looking Statements 2 This presentation and our discussion contain forward-looking information and statements including, but not limited to, our

More information

Anika Therapeutics, Inc.

Anika Therapeutics, Inc. Anika Therapeutics, Inc. Canaccord Genuity 34th Annual Growth Conference August 14 th, 2014 Safe Harbor Statement The statements made in this presentation, which are not statements of historical fact,

More information

A Bibliometric Analysis of Biomedical Research in Australia Final Report

A Bibliometric Analysis of Biomedical Research in Australia Final Report A Bibliometric Analysis of Biomedical Research in Australia Final Report Kumara Henadeera and Bev Biglia Research Evaluation and Policy Project Research School of Social Sciences The Australian National

More information

Official Journal of the European Union

Official Journal of the European Union C 186/40 Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance) (Publication of titles and references of

More information

NOTICES FROM MEMBER STATES

NOTICES FROM MEMBER STATES C 267/10 NOTICES FROM MEMBER STATES Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance) (Publication

More information

Chargemaster Fundamentals for a Solid Revenue Cycle Foundation. November 7, 2012 John Behn

Chargemaster Fundamentals for a Solid Revenue Cycle Foundation. November 7, 2012 John Behn Chargemaster Fundamentals for a Solid Revenue Cycle Foundation Understanding the Importance, Purpose and Function of your Charge Data Master November 7, 2012 John Behn National Rural Health Resource Center

More information

Progress Report. Paul Smit Philips Medical Systems

Progress Report. Paul Smit Philips Medical Systems Progress Report Paul Smit Philips Medical Systems Forward Looking Statements Forward Looking Statements This document contains certain forward-looking statements with respect to the financial condition,

More information

2009 Audio Seminars/Webinars

2009 Audio Seminars/Webinars AHIMA /s Registration Form 1 AHIMA / Registration Form REGISTER TODAY! Mark the sessions you want to attend and indicated the preferred format. Please include all pages of this registration form when registering.

More information

NOTICES FROM MEMBER STATES

NOTICES FROM MEMBER STATES 23.7.2008 C 186/9 NOTICES FROM MEMBER STATES Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance) (Publication

More information

Contract Number Start Date End Date Contract Description Ann Value MED /07/ /07/2016 CYTOTOXIC DOSE BANDED PHARMACEUTICALS MED3103

Contract Number Start Date End Date Contract Description Ann Value MED /07/ /07/2016 CYTOTOXIC DOSE BANDED PHARMACEUTICALS MED3103 MED3147 16/07/2012 15/07/2016 CYTOTOXIC DOSE BANDED PHARMACEUTICALS 146240 MED3103 01/05/2012 16/07/2016 SATURATION PROBES & PULSE OXIMETERS 52505 NOM4440 20/07/2015 19/07/2016 DISCLOSURE BARRING SERVICE

More information

Perioperative management of patients on warfarin requiring elective surgery Dr K Boyd, Mrs S Doyle

Perioperative management of patients on warfarin requiring elective surgery Dr K Boyd, Mrs S Doyle CLINICAL GUIDELINES ID TAG Title: Author: Speciality / Division: Directorate: Perioperative management of patients on warfarin requiring elective surgery Dr K Boyd, Mrs S Doyle Haematology Acute Date Uploaded:

More information