We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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
NeuroPace plans to launch its RNS Stimulator in the U.S. as soon as possible, following last week’s FDA approval of the novel anti-seizure device. Read More
The FDA has granted 510(k) clearance for next-generation software that allows collection of plasma alone on Fenwal’s Alyx blood collection system. Read More
The FDA Wednesday granted TauTona 510(k) clearance for its battery-powered, single use TauTona Tissue Injector (TTI) fat-grafting device for use in aesthetic and reconstructive surgeries. Read More
An effort to foster better communication between the FDA’s drug and device centers is starting to pay off, with fewer requests for duplicate data on companion diagnostic submissions. Read More
RSS
