Navigation Links
FDA Launches Medical Device Innovation Initiative
Date:2/8/2011

ve medical devices that reduce suffering and treat previously untreatable conditions," said CDRH Director Jeffrey Shuren, M.D., J.D. "CDRH's Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs."

The FDA has accepted its first submission from the Defense Advanced Research Projects Agency (DARPA) to review a brain-controlled, upper-extremity prosthetic designed to restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation. The arm system uses a microchip implanted on the surface of the brain to record neuronal activity and decode the signals to actuate motor neurons that control the prosthesis. DARPA and the FDA have signed a Memorandum of Understanding addressing both the development and review of this project.

The proposed Innovation Pathway program includes the following features:

  • products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;
  • selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and
  • products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and deter
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. UrgentRx Launches Line of Innovative and Portable, Fast-Acting Medications Across Colorado
2. Stiefel Launches Most-Prescribed BPO Wash Formulations Over-the-Counter
3. SkinMedica Launches Redness Relief CalmPlex™
4. Valeant Launches Senior Notes Offering
5. Merz Launches New Online Resource for Patients with Focal Dystonias
6. Thats Nice LLC Launches Nice Insight Marketing Intelligence for CRAMs With Its Pharma & Biotech Outsourcing Survey
7. REMCON Plastics Launches Aggressive 5 year Plan by Hiring New National Sales and Marketing Professional
8. Avantra Biosciences Launches Multiplex System for Faster, Easier Quantification of Cancer Protein Biomarkers
9. Global Coalition on Aging Launches as 450 Million People Turn 65 Over Next Two Decades
10. eCareSoft Launches Comprehensive EHR for Small & Medium Hospitals
11. TheCarrot.com Launches Quit Smoking Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... , Aug. 20, 2014  Quantum Materials Corporation ... sets of patent families from Bayer Technology Services GmbH, ... for Bayer AG of Leverkusen, Germany ... provide broad intellectual property protection for advances ... quantum dot (QD) manufacturing. In addition, the Bayer ...
(Date:8/20/2014)... Glenmark Pharmaceuticals S.A. (GPSA), ... India (GPL), announces the discovery and initiation of ... candidate, GBR 1302, a HER2xCD3 bispecific antibody. GBR ... Biologics Research Centre located in La Chaux-de-Fonds, ... on Glenmark,s innovative BEAT antibody technology platform which ...
(Date:8/20/2014)... 20, 2014 Phase I Trial ... US  KalVista Pharmaceuticals ("KalVista"), an ophthalmology company ... announces that it has begun a Phase I, First ... KVD001, for the treatment of DME. The study,s Principal ... Eye Institute, Joslin Diabetes Center; Harvard Medical School Department ...
Breaking Medicine Technology:Quantum Materials Acquires Bayer Technology Services Quantum Dot Manufacturing and Quantum Dot Solar Cell Patents 2Quantum Materials Acquires Bayer Technology Services Quantum Dot Manufacturing and Quantum Dot Solar Cell Patents 3Quantum Materials Acquires Bayer Technology Services Quantum Dot Manufacturing and Quantum Dot Solar Cell Patents 4Glenmark Enters Oncology With the Discovery and Initiation of IND Enabling Studies of an Innovative Bispecific Antibody 2Glenmark Enters Oncology With the Discovery and Initiation of IND Enabling Studies of an Innovative Bispecific Antibody 3KalVista Pharmaceuticals Announces Start of Clinical Development for Novel Treatment for Diabetic Macular Edema 2KalVista Pharmaceuticals Announces Start of Clinical Development for Novel Treatment for Diabetic Macular Edema 3KalVista Pharmaceuticals Announces Start of Clinical Development for Novel Treatment for Diabetic Macular Edema 4
... Information Systems ("SIS"), a leader in perioperative ... leadership in achieving clinical, financial, and operational goals ... the company,s annual client conference, the 2012 SIS ... systems exemplifying the innovative use of information technology ...
... 2012 Top leaders representing America,s advanced medical ... public policy issues affecting job creation and medical innovation and ... billion medical device tax set to begin in January 2013. ... Renacci (R-Ohio) joined Walter M Rosebrough, president and CEO of ...
Cached Medicine Technology:Surgical Information Systems Recognizes Clients for Financial, Clinical, and Operational Improvements 2Surgical Information Systems Recognizes Clients for Financial, Clinical, and Operational Improvements 3Surgical Information Systems Recognizes Clients for Financial, Clinical, and Operational Improvements 4AdvaMed & BioOhio Discuss MedTech Impact on Ohio's Economy, Job Creation 2AdvaMed & BioOhio Discuss MedTech Impact on Ohio's Economy, Job Creation 3
(Date:8/20/2014)... B. E. Smith, the only full-service ... been retained to lead a national chief operating ... in Hermiston, Ore. The top executive search firm ... recently placed more than 900 healthcare executives into organizations. ... progressive, not-for-profit healthcare organization serving a population of more ...
(Date:8/20/2014)... 2014 Biosimilars, which are similar ... through an abbreviated process, could reap billions in ... Information Services, Inc.’s (AIS) Specialty Pharmacy News offers ... the Food and Drug Administration’s (FDA) recent acceptance ... approval. , Drugmaker Sandoz said July 24 that ...
(Date:8/20/2014)... 20, 2014 Building on growing ... successfully predicted stage iii and iv pressure ulcers ... situations, approached 90%. A company spokesperson commented that ... commercial or academic settings. The resulting capabilities can ... of hospital-acquired conditions to help providers avoid financial ...
(Date:8/20/2014)... August 20, 2014 BuyCheapTicketsToEvents.com is ... wide selection of tickets to many events. Cheap NHL hockey ... begin in September. , Hockey fans are enthusiastic about their ... tickets for games. Now is the time to acquire 2014 ... in mere months. There will be a great deal of ...
(Date:8/20/2014)... The “Human Insulin Market by ... Premixed), Modern Human Insulin (Rapid Acting, Long Acting, ... Tresiba, Others) - Forecast to 2019” provides a ... current market trends,and strategies impacting the global human ... of the revenue and share analysis. , Browse ...
Breaking Medicine News(10 mins):Health News:Good Shepherd Health Care System Retains B. E. Smith to Recruit New COO 2Health News:Good Shepherd Health Care System Retains B. E. Smith to Recruit New COO 3Health News:AIS Newsletter Tracks Latest Developments in Biosimilars Market as FDA Accepts First Application 2Health News:AIS Newsletter Tracks Latest Developments in Biosimilars Market as FDA Accepts First Application 3Health News:Jvion Achieves Benchmark Accuracy in Pressure Ulcer Prediction 2Health News:2014 NHL Preseason Tickets Are Among Top Selling Seats at Trusted Provider BuyCheapTicketsToEvents.com 2Health News:Human Insulin Market by Product Types and Brand Worth $42 Billion by 2019 - New Report by MarketsandMarkets 2Health News:Human Insulin Market by Product Types and Brand Worth $42 Billion by 2019 - New Report by MarketsandMarkets 3Health News:Human Insulin Market by Product Types and Brand Worth $42 Billion by 2019 - New Report by MarketsandMarkets 4
... , , , WOBURN, ... died Wednesday, August 12, 2009 at Massachusetts General Hospital in Boston. Doctors say ... 55 years old. , , Dr. Gilbard is best known ... condition that is caused by a chronic lack of moisture in the eye. ...
... , HATBORO, Pa., Aug. 13 InfoLogix, Inc. (Nasdaq: ... the healthcare and commercial industries, today announced financial results for the quarter ... http://www.newscom.com/cgi-bin/prnh/20090618/NE3513 5 LOGO ) , ... , David T. Gulian, president and chief executive officer ...
... uncertain, researchers say , THURSDAY, Aug. 13 (HealthDay News) ... out and destroy the stem cells that scientists believe ... growing body of research is showing that cancer stem ... causing cancer to reappear even after treatment seems to ...
... , , MECHANICSBURG, Pa., Aug. 13 ... quarter ended June 30, 2009. , , ... revenues increased 3.8% to $559.5 million compared to $538.8 million ... increased 35.0% to $65.4 million compared to $48.4 million for ...
... , , , ... CRDC ) today reported financial results and corporate progress for ... , , "With a slower than expected ... fiscal fourth quarter we had to make difficult decisions to revise ...
... , U.S. Rep. Barbara Lee (D-Calif.) Also to be ... The intensifying debate about health care reform in America will be addressed this ... Aug. 14 at 10 a.m. EDT nationwide on Federal News Radio at ... Washington , D.C. , area. , , ...
Cached Medicine News:Health News:Ophthalmology Pioneer Dr. Jeffrey P. Gilbard Dies 2Health News:Ophthalmology Pioneer Dr. Jeffrey P. Gilbard Dies 3Health News:InfoLogix Announces Second Quarter Financial Results 2Health News:InfoLogix Announces Second Quarter Financial Results 3Health News:InfoLogix Announces Second Quarter Financial Results 4Health News:InfoLogix Announces Second Quarter Financial Results 5Health News:InfoLogix Announces Second Quarter Financial Results 6Health News:InfoLogix Announces Second Quarter Financial Results 7Health News:InfoLogix Announces Second Quarter Financial Results 8Health News:Compound Targets, Destroys Cancer Stem Cells in Mice 2Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 2Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 3Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 4Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 5Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 6Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 7Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 8Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 9Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 10Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 11Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 12Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 13Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 14Health News:Select Medical Corporation Announces Results for Second Quarter Ended June 30, 2009 15Health News:Cardica Announces Fiscal 2009 Fourth Quarter and Year End Financial Results 2Health News:Cardica Announces Fiscal 2009 Fourth Quarter and Year End Financial Results 3Health News:Cardica Announces Fiscal 2009 Fourth Quarter and Year End Financial Results 4Health News:Cardica Announces Fiscal 2009 Fourth Quarter and Year End Financial Results 5Health News:Cardica Announces Fiscal 2009 Fourth Quarter and Year End Financial Results 6Health News:Cardica Announces Fiscal 2009 Fourth Quarter and Year End Financial Results 7Health News:Cardica Announces Fiscal 2009 Fourth Quarter and Year End Financial Results 8Health News:Cardica Announces Fiscal 2009 Fourth Quarter and Year End Financial Results 9Health News:Health Care Reform to be Discussed on 'Inside Government' 2
... reads, writes and prints "Smart" labels. As ... or barcode on the label surface. SATO's ... a range of applications, including: Compliance Labeling, ... Tagging, Retail Labeling, Product Authentication. CL408e RFID ...
... is a core software component ... which enables location-based applications in ... capabilities of the AeroScout Engine ... management of AeroScout hardware and ...
... The Kisses tag is part ... of the Hugs system. The Kisses ... mother after it has been bonded ... her baby. he two tags remain ...
... Radianse active-RFID-tags can be ... For example, that a device ... complete or that a patient ... Every message from an ID-tag ...
Medicine Products: