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Utah Cord Bank Hit with Warning Letter

[ Price : $8.95]

A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) determines that the firms cell products StemVive and St...

Globus Medical Excelsius Imager Cleared

[ Price : $8.95]

FDA has cleared a Globus Medical 510(k) for the Excelsius3D, an intraoperative three-in-one imaging system.

12 Observations on Imprimis FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with 12 observations from an inspection at the Imprimis drug compounding facility in Lakewood, NJ.

FDA Prioritizing Medical Device Cybersecurity: Post

[ Price : $8.95]

MedTech Dive says FDA is seeking legislative authorities to prioritize medical device cybersecurity by imposing new requirements o...

QS Issues Found in Tianjin Bolang Science Tech. Inspection

[ Price : $8.95]

FDA warns Chinas Tianjin Bolang Science Technology Development Co. about Quality System violations in its production of three medi...

BlackBerry QNX Cybersecurity Vulnerabilities

[ Price : $8.95]

FDA says it is working with federal agencies, medical device manufacturers, and the private sector to resolve cybersecurity vulner...

Studies Confirm Boston Scientifics Mesh Withdrawal

[ Price : $8.95]

Two Boston Scientific post-market surveillance studies confirm the unfavorable benefit-risk profile of now-withdrawn Boston Scient...

Thermo Fisher Gets 2 EUAs for Covid Tests

[ Price : $8.95]

FDA grants Thermo Fisher Scientific emergency use authorizations for the TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath C...

Lillys Lyumjev OKd for Insulin Pump

[ Price : $8.95]

FDA approves Eli Lillys rapid-acting insulin Lyumjev (insulin lispro-aabc injection) 100 units/mL for administration by continuous...

Former FDA Head Hahn Urges FDA Independence

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Former Trump administration FDA commissioner Stephen Hahn urges more independence for the agency to prevent political interference...