News In Brief
This article was originally published in The Gray Sheet
IDS’ laser-based breast imaging system requires PMA
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Firm’s therascreen KRAS test will guide Erbitux drug treatment for patients with metastatic colorectal cancer following FDA approval, announced July 6. About 110,000 U.S. patients annually could benefit from the test for the indication, representing a $20 million market opportunity.
Berlin Heart’s Excor Pediatric ventricular assist device gains FDA humanitarian device exemption approval. Cerevast Therapeutics gains CE mark for Clotbust ER ultrasound device to treat ischemic strokes. More new products.
OraSure Technologies expects to complete a PMA filing for its OraQuick Advance rapid HIV-1 and -2 over-the-counter saliva test by the end of the year.