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Oculus Innovative Sciences has received 510(k) clearance for its Microcyn hydrogel for scars resulting from burns, surgery or trauma wounds, with the FDA recognizing the device as substantially equivalent to similar products. Read More
The FDA has granted Japan’s Sumitomo Heavy Industries its first 510(k) clearance for a 23 MeV cyclotron proton beam radiation therapy device that targets cancer cells. Read More
Devicemakers seeking regulatory approval in the U.S. are strongly urged to blind patients and investigators in pivotal clinical trials, when possible, according to final guidance issued by the Food and Drug Administration. Read More
Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More
The IMDRF has released a proposal that will guide devicemakers on producing a comprehensive Table of Contents for premarket IVD applications. Read More
EU devicemakers will have a chance to speak directly with top FDA officials at a three-day workshop on human factors for medical devices scheduled for April 1-3, 2014. Read More
Sitoa Global and the University of California San Francisco have signed a letter of intent to negotiate an option agreement for the license of a stereotactic device to deliver stem cells directly into the brain. Read More
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