Medical Devices Today

FDA Diagnostics Office Seeks Bigger Role In Personalized Medicine

Full article reprinted from "The Gray Sheet" - April 27, 2009

 FDA officials that regulate lab tests don't think they have been active enough in the policy debate over the future of personalized medicine; but, they say, that is about to change.

Full article reprinted from "The Gray Sheet" - April 27, 2009

FDA is hiring additional staff and channeling user fee funds toward device reclassification efforts now that it has committed itself to more rapidly addressing the subset of Class III devices that still enters the market via 510(k).

FDA Device Center Gears Up For Product Reclassification Push

Full article reprinted from "The Gray Sheet" - April 27, 2009

Find out how FDA is hiring additional staff and channeling user fee funds toward device reclassification efforts now that it has committed itself to more rapidly addressing the subset of Class III devices that still enters the market via 510(k).

Orthocon closes $25mm Series B round

Deal summary reprinted from Strategic Transactions - April 2009

Orthocon (absorbable products for orthopedic and spine surgeries) raised $25mm in its Series B financing that was co-led by ProQuest Investments and Canaan Partners with additional funds coming from returning shareholder BB Biotech Ventures.

Vascular Closure Devices at the Crossroads

Article preview reprinted Medtech Insight - April, 2009 

Find out how the rapid proliferation of catheter-based interventional devices and procedures over the past two decades has revolutionized the diagnosis and treatment of coronary and peripheral vascular disease, enabling physicians to gain access to diseased vessels using only an introducer needle, guidewire, and catheter.

AeonClad Biomedical LLC

Article preview reprinted from Start-Up - March, 2009

AeonClad Biomedical 's AeonCoat coating technology allows for surface modification at the nanoscale or particle level.

How to Earn the Economic Payback Diagnostics Companies Deserve

Article preview reprinted from IN VIVO - March, 2009   

For most diagnostics companies, the prospect of premium pricing has been an elusive dream. The health care landscape is peppered with expensive novel drugs priced to underscore their clinical impact on patient care.

FDA Wins Injunction Against Endotec “Custom” Ankles And Knees

Full article reprinted from "The Gray Sheet" - April 20, 2009

Find out how orthopedic device maker Endotec's Buechel-Pappas ankles are not custom devices and therefore not exempt from pre-market requirements, according to a recent U.S. appeals court decision.

DoJ Targets Device Labeling Accuracy In $300 Million Quest Settlement

Full article reprinted from "The Gray Sheet" - April 20, 2009

Find out how a $302 million settlement between Quest Diagnostics and the Department of Justice announced April 15 suggests DoJ will go after device firms for knowingly misrepresenting product information in labeling and marketing materials, even if FDA is not actively investigating the matter.

Just Published: Medical Devices & Diagnostics Industry – 2009 Market Outlook

FDC-Windhover announces the publication of a new Special Report: the “Medical Devices & Diagnostics Industry – 2009 Market Outlook.” 
 
This 119-page Special Report contains 23 articles about the current state of medical devices and diagnostics industry compiled from recent issues of IN VIVO, Medtech Insight and Start-Up.

The report examines the current economic landscape and its impact on the industry with a special emphasis on the cardiovascular, orthopedic, brain, pulmonary, metabolic and ophthalmic sectors. It also includes a special look at the diagnostics industry and some noteworthy start-ups.

This report was compiled especially to address how our industry is fairing in these tough economic times: who’s struggling and who’s likely to succeed.

It also provides a comprehensive sampling of the uniquely in-depth devices and diagnostics industry insight that you can only get from IN VIVO, Medtech Insight and Start-Up.

Click here to find out how you can get this Special Report and review the complete table of contents online.

For more information about our medical device publications, contact Sean Smith at 240-221-4535 or [email protected].