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Washington, D.C.-based MedStar Health has signed a deal licensing to InnoVital Systems the intellectual property rights to the artificial muscle technology that it hopes will power the InVent diaphragm assist device. 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
The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data. 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
Medical devicemakers should avoid recruiting and putting at risk an unnecessarily large number of patients in clinical trials, the UK’s Medicines and Healthcare products Regulatory Agency says in one of five trial-related guidances issued last month. 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
An interim report on the joint assessments of EU device notified bodies (NBs) shows there is room for improvement in the planning, scope and depth of surveillance activities. Read More