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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
The FDA has granted 510(k) clearance for Bruker's MALDI Biotyper CA system for the identification of Gram negative bacteria from human samples using proteomic fingerprinting. Read More
San Diego-based Illumina will begin filling orders for its high-throughput gene sequencing tests and two other diagnostics by the end of the year, following FDA 510(k) clearance of all four devices. Read More
The FDA has warned an online marketer of genetic tests to pull its products off the market until it obtains regulatory clearance, saying the company has not demonstrated that the tests do what it claims they do. Read More
The FDA has granted 510(k) clearance for Kinetic Concepts’ V.A.C. Via negative-pressure wound therapy device for patients whose wounds drain 80 mL or less of exudate per day. Read More