Medical Devices Today

Breakthrough Devices Will Get Priority Reviews Under CDRH Initiative

Article preview from "The Gray Sheet" - February 9, 2011

For a select few devices per year, FDA says it will speed up pre-market decision times by intensifying staff efforts, with a particular focus on very early-stage interactions with product sponsors.

J&J; Snaps Up Rare Cell Capture And Analysis Technology From Mass General

Article preview from In-Vivo- January 1, 2011

Mass General has signed a $30 million deal with two units of J&J to develop a new system for capturing and analyzing circulating tumor cells (CTCs). The collaboration aims to develop a standardized diagnostic platform for biomarker analysis of DNA, RNA, or protein from tumor cells collected noninvasively. J&J will take the indications for its current CTC system, CellSearch, and migrate them to the new platform.

Cell-Based Solutions for Neurologic Disease

Article preview from Medtech Insight - Januray 1, 2011

Emerging tissue-engineering and cell transplantation therapies have the potential to provide solutions to many of the treatment challenges facing neurologists today.

Will Rise of Corporate Investors Lead to Return of Device Returns?

Article preview from Start Up- January 1, 2011

Corporate investors are taking an interest - and equity stakes - in more medical devices start-ups.

"FDA Posts Criteria For Targeting Individual Execs As "Responsible Officers"

Article preview from "The Gray Sheet" - February 7, 2011

Almost a year after signaling its intent to target more executives with misdemeanor prosecutions when their companies have broken the law, FDA has published its criteria for pursuing such cases.

Brookings, Dartmouth Create Accountable Care Organization Toolkit

Article preview from "The Gray Sheet" - February  2, 2011

As the health care sector awaits guidance from CMS on the accountable care organization program called for under the health reform law, policy groups within The Brookings Institution and Dartmouth Medical School have created a toolkit to help people get started.

Top Device Stories Of 2010: Waiting For The Other Shoes To Fall

Article preview from In-Vivo- January 1, 2011

For much of the device industry, 2010 felt like a transition year, breeding uncertainty in a number of important areas, including the economy, health care reform, and impending changes to the 510(k) process. A review of the year just ended turns up these stories: Device M&A on the Rebound; Is A First-Mover Advantage Emerging In Medtech? Boston Scientific Is Back In The Game; Early-Stage Deals In Decline; The Future Of Medtech: Where Private Investment Dollars Are Flowing; Transcatheter Valves Take Center Stage; Spine's Downturn; Diabetes Assumptions Begin To Shift; A Landmark Year In Ophthalmology; Health Reform In 2010: A Beginning, Not An End; Changes At FDA: 510(k) Reform Takes Shape, and finally, Is Physician Choice In Product Selection In Danger?

Devices Expand Their Role in Retinal Disease

Article preview from Medtech Insight - Januray 1, 2011

Four years following FDA approval, Lucentis remains the standard of care for the treatment of neovascular (wet) age-related macular degeneration (AMD) and has been widely adopted for off-label treatment of other retinal diseases. Companies are pursuing new drugs that may have more favorable dosing profiles, device-based technologies that may reduce the dosing frequency of Lucentis, and implantable drug delivery vehicles designed to deliver drugs to the back of the eye that may be applicable to a broad range of retinal therapies.

MiCardia Corp.

Article preview from Start Up- January 1, 2011

Patients requiring mitral valve repair of the heart to reduce recurrent leakage of blood or residual regurgitation after initial implant can now avoid going under the knife for a second time. MiCardia's Dynaplasty platform has been designed to change the shape of an implantable medical device in response to fluctuations in anatomical conditions. For mitral valve repair, MiCardia's shape-memory nitinol device is similar to a standard annuloplasty ring, but when activated, pulls the two leaflets together in such a fashion as to significantly minimize regurgitation.

Republicans Renew Push To Repeal Device Tax; Broad Support Questionable

Article preview from "The Gray Sheet" - January 31, 2011

Republicans in Congress introduced bills last week that would repeal the medical device excise tax before it takes effect in 2013, but few Democrats have jumped on board publicly so far.