VisionCare’s FDA Approved Telescope Gets Implanted
VisionCare’s lead product, Implantable Miniature Telescope by Dr. Isaac Liphitz, enlarges images in front of the eye approximately 2.5 times their normal size.
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Protected: OneMedRadio: The JOBS Act — Promises and Pitfalls
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Medical Device Hearings Slated For This Week On Capital Hill
A pair of hearings on Capitol Hill this week aim to peer closely at how the medical device industry interacts with regulators at the FDA.
Government Shutdown Implications For the FDA
A government shutdown will severely restrict food and drug inspections. The FDA will not be able to conduct specific inspections of drug or medical device manufacturing facilities.
April 13 – 14, 2011 4th Annual FDA/MTLI Medical Device and IVD Statistics Workshop
This annual conference brings together leading authorities from FDA, industry, and academia to address statistical issues related to medical technology clinical studies
Is Europe A Better Place To Build A Medical Technology Company? (Video)
Growth in the life sciences industries will greatly depend on how the FDA responds to growing complaints that they are stifling medical technologies.
Mobisante Wins FDA Approval For The World’s First smartphone-based ultrasound imaging system
Mobisante, Inc., a privately held medical device company located in Redmond, WA, announced recently that it has received 510(k) clearance from the FDA for its smartphone-based ultrasound imaging system, MobiUS.
Getting the Scoop on 510(k)s
In the halls of government agencies throughout Washington, DC, plans are being made to implement reform measures that will reshape the nation’s healthcare policies—and the health of millions of Americans.
Northwestern Investigators to Launch 510(k) Survey
Recent controversy surrounding FDA’s processes for premarket review of medical devices has ignited a discussion among researchers in hope of getting to the crux of the issue.
No Shortage of Hopefuls in the Multibillion-Dollar Blood Thinner Business
Patients hoping for a new alternative to the blockbuster blood thinner Plavix will have to wait a bit longer for a verdict on a promising candidate.