Medical Devices Today

FDA Shake Up Could Undercut Returns on 510(k)s

Full article reprinted from Start Up - November/December 2009

The ongoing review of the Food and Drug Administration's 510(k) program for medical devices promises to clamp down on a regulatory path that device investors generally have regarded as a lower-cost, faster-paced path to commercialization for portfolio companies. The self-analysis by the agency--combined with an external review by the Institute of Medicine--likely might lead to the FDA requiring more detailed--and costly--analysis for product approval. Read more...

In Europe, Medtronic and Sofinnova Launch an Accelerator

Article preview reprinted from IN VIVO -  November/December, 2009  

One of Europe's leading venture capital firms, Paris-based Sofinnova Partners and device industry powerhouse Medtronic Inc. have announced plans to launch a new medical device incubator or accelerator in Europe-born out of what executives at both companies see as a fundamental disconnect between the clinical and technological richness of Europe and the practical reality of starting a company there. The new organization, designed to take advantage of what both companies believe is a wealth of untapped potential for new device ideas from European physicians, is located on the campus of the École Polytechnique Fédéral de Lausanne, one of the leading technical institutes in Europe. Read more...

CMS Clarifies Medicare Policy For Embolic Protection With Carotid Stenting

Full article reprinted from "The Gray Sheet" - December 14, 2009

CMS revised its carotid artery stenting policy Dec. 9 to ensure that new embolic protection devices used in conjunction with carotid stents are covered by Medicare, and to clarify that the stenting procedure cannot be covered without the use of a protection device. Read more...

Four Device Makers Apply For 2011 New-Technology Add-On Bonus

Full article reprinted from "The Gray Sheet" - December 14, 2009

CMS has received five applications from four device firms for its next round of new-technology add-on payments, including submissions for two products that did not qualify for the extra payment during previous attempts. Read more...

With Device Tax Seeming Inevitable, Groups Align On Small-Firm Protections

Full article reprinted from "The Gray Sheet" - December 14, 2009

Groups representing the device industry have aligned to push an amendment to the Senate health care reform bill to exempt more pre- and low-profit companies from the proposed $20 billion device tax. Read more...

Fulfilling the Promise of the Scarless Surgery Revolution

 

"Fulfilling the Promise of the Scarless Surgery Revolution" Special Report published by Elsevier Business Intelligence.

When will breakthrough endoscopic technologies hit prime time?
Originally published in Medtech Insight: Medical Technology Market Intelligence®

Find out how you can get this report for FREE

Recent Developments in PFO Closure

Article preview reprinted from Medtech Insight - October/November 2009

The patent foramen ovale closure market has continued to mature in 2009, with the latest round of developments reported at the 2009 Transcatheter Cardiovascular Therapeutics meeting, recently held in San Francisco. Over 60 presentations related to PFO closure or atrial septal defect closure were presented at TCT this year, more than double the amount of PFO-related talks presented in 2008. Read more...

Noninvasive Prenatal Diagnostics: How Much Closer to Reality?

Article preview reprinted from IN VIVO -  October/November, 2009  

Whether the astonishing missteps by Sequenom, which earlier this year disclosed it could not support its data for a non-invasive Down Syndrome test, were merely poor management or a reality check for the field of non-invasive prenatal disgnostics, the NIPD opportunity is compelling. But the profession also understandably balks at obtaining information that is not then clinically actionable -- an issue that could further amplify in importance as technologies like microarrays and direct DNA sequencing increase become more prevalent. Read more...

Medtronic Names Ultrasound Innovator As VP Of Cardiovascular Unit

Covidien, GE MRI Drugs Said By FDA Advisers To Be Riskier Than Others

Medtronic Study Shows Long-Term Benefit Of Epileptics Brain Stimulator

Medtronic Plans Calif. Facilities Makeover In Transition To R&D

GE, Toshiba CT Scanners Probed For Excessive Radiation Levels

C.R. Bard, Spire Agree For Fourth Time To Postpone Acquisition

Advanced Medical Sued In Texas For Opthalmic Viscosurgical Device

St. Jude’s Unique Neurostimulator Gets FDA Clearance

Medtronic Paid Physician As He Served On University Ethics Panel

Abbott Reports Early Success With Dissolvable Heart Stent

Abbott Lays Off 80 Temps At North Carolina Stent-Making Plant

Medtronic Hires St. Jude Business Driver To Head Heart-Device Unit

Smith & Nephew Patent Suit Against Anthrex Sent Back To Court

Bayer Counts On Alzheimer’s, Parkinson’s Diagnostics To Drive Sales

Cook Hopes Biliary Stent Data Will Break Boston Scientific's Dominance

Full article reprinted from "The Gray Sheet" - December 7, 2009

Armed with data showing that its Zilver 635 self-expanding biliary stent measures up to Boston Scientific's market-dominating Wallstent , Cook Medical hopes to carve out a larger share of the $90 million segment. Read more...