Tempus files a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro diagnostic device intended to assist healthcare professionals with da...
A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) determines that the firms cell products StemVive and StemMaxx are unapprove...
FDA has cleared a Globus Medical 510(k) for the Excelsius3D, an intraoperative three-in-one imaging system.
FDA releases the FDA-483 with 12 observations from an inspection at the Imprimis drug compounding facility in Lakewood, NJ.
MedTech Dive says FDA is seeking legislative authorities to prioritize medical device cybersecurity by imposing new requirements on manufacturers.
FDA warns Chinas Tianjin Bolang Science Technology Development Co. about Quality System violations in its production of three medical devices.
FDA says it is working with federal agencies, medical device manufacturers, and the private sector to resolve cybersecurity vulnerabilities in a Black...
Two Boston Scientific post-market surveillance studies confirm the unfavorable benefit-risk profile of now-withdrawn Boston Scientifics transvaginal m...