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De Novo OK for ArteraAI Prostate Software

[ Price : $8.95]

FDA grants de novo authorization for the ArteraAI Prostate test, a risk-stratification tool to help providers and patients make tr...

HHS Touts Pharmacy on Demand Project

[ Price : $8.95]

HHS touts its work with On Demand Pharmaceuticals Pharmacy on Demand modular drug manufacturing unit that uses artificial intellig...

FDA Clears DeepSights NeedleVue Ultrasound

[ Price : $8.95]

FDA clears a DeepSight Technology 510(k) for its NeedleVue LC1 Ultrasound System for image-guided medical procedures.

FDAer Quits, Flips Off Trump/Vance in Viral Post

[ Price : $8.95]

FDA Office of Privacy information specialist Elizabeth Booker Houstons recent departure goes viral after dramatically announcing h...

Agency RIF Packets Cause Privacy Concerns

[ Price : $8.95]

Some fired FDA employees say they received sensitive information about other employees in addition to their own.

CGMP Issues at Private Label Grooming

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FDA warns Henderson, NV-based Private Label Grooming about CGMP violations in its production of over-the-counter drugs.

Multiple Violations in Spectra Therapy Inspection

[ Price : $8.95]

FDA warns Port Huron, MI-based Spectra Therapy about Quality System, Medical Device Reporting, and Unique Identifier violations in...

Promising Ianalumab Data for Thrombocytopenia: Novartis

[ Price : $8.95]

Novartis says its experimental antibody ianalumab, when combined with eltrombopag, significantly extended the time to treatment fa...

Draeger Recalls Ventilator Breathing Filters

[ Price : $8.95]

Draeger recalls (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide readings.

Elsa Hallucinations Not A Surprise: AI Expert

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AI expert Brooke Moy says FDA may have felt pressured to move too quickly to implement its Elsa internal AI tool without planning ...