Medical Devices Today

Dropping GPOs: Medtronic's Hawkins Expects More Of It From MedTech

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

Medtronic CEO Bill Hawkins says he would be "shocked" if some competitors did not follow his firm's lead this year with cancellations of large group purchasing organization contracts.

In Vitro Diagnostics: The Quest For Growth

Article preview from IN VIVO - January, 2011

The quest for market growth in the in vitro diagnostics (IVD) space is taking manufacturers down a number of avenues, as they seek to counter the effects of the economic downturn that has hit particularly hard in the US and Western European markets over the past couple of years.

Diagnostics Groups Support Risk-Based Regulatory Regime In Europe

Article preview from "The Gray Sheet"- February 28, 2011

Respondents to a European Commission survey, including diagnostics makers and clinical labs, support the creation of a new, risk-based classification system for in vitro diagnostic devices in Europe.

President's 2012 Budget Request Increases Device Program Funding

Article preview from "The Gray Sheet" - February 21, 2011

The Obama administration's $329 million in requested 2012 appropriations for FDA's device center would fund special projects, including a national device registry surveillance system and technologies to respond to biological and nuclear emergencies.

e(ye)BRAIN GMBH

Article preview from Start-Up - January, 2011

Could the eyes hold the key to diagnosing neurologic conditions by associating eye movement behavior to specific areas of the brain? French start-up e(ye)BRAIN certainly thinks so, and as a result has developed a brain tracking medical device that its inventor claims is able to diagnose Parkinson's disease and multiple sclerosis.

Video Tech Boosts Airway Management Market

Article preview from Medtech Insight - January, 2011

Innovation in intubation devices, particularly video-enabled technology, is breathing new life into the market for airway management products. At the 2010 meeting of the American Society of Anesthesiologists, held in San Diego in October, manufacturers showcased a variety of new intubation devices designed to improve visualization, avoid complications, and provide fast and simple solutions for patients with difficult airways.

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.

FDA 510(k) Reform Plan Yields Mixed Readings

Article preview from "The Gray Sheet" - January 24, 2011

Readings were mixed on what the ultimate impact will be on the medical device industry and on patient safety from FDA's 510(k) reform plan announced Jan. 19.

Abbott Sees Absorb Bioresorbable Implant As Stent Market Game Changer

Article preview from "The Gray Sheet" - January 17, 2011

Abbott will commence a 2,000-patient clinical trial by year end to support U.S. approval of its Absorb drug-eluting bioresorbable vascular scaffold as an alternative to conventional coronary stents following an initial European debut.

Industry Meets With FDA On Mobile Health Regulatory Plan

Article preview from "The Gray Sheet" - January 12, 2011

Members of the mHealth Regulatory Coalition representing the medical device, wireless communication and software industries met Jan. 10 with more than a dozen FDA staffers to discuss next steps for creating agency guidance on mobile health devices.