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T2 Biosystems files a 510(k) for the T2Bacteria Panel that is designed to run on the companys T2Dx Instrument as a rapid diagnosti...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance #210 entitled The Index of Legally Marketed Unapproved New Animal Dr...[ Price : $8.95]
Federal Register notice: FDA makes available the safety and effectiveness summaries of recent PMAs approved by CBER.[ Price : $8.95]
CDRH associate director Suzanne Schwartz says medical device manufacturers should build cyber security into their devices at the d...[ Price : $8.95]
FDA says an ICH guidance on genomic sampling and data has passed Step 4 and is being implemented.[ Price : $8.95]
Attorney Rachel Weil says a New Your federal court has ruled that a liability suit against Bayer over its Essure birth control dev...[ Price : $8.95]
FDA approves Amgens Mvasi, a biosimilar to Genentechs Avastin, for treating multiple forms of cancer.[ Price : $8.95]
FDA issues a guidance to facilitate study designs establishing performance characteristics of in vitro diagnostic devices intended...