FDA clears an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspected vertebral compress...
FDA clears a Getinge 510(k) for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance).
FDA clears a Spinal Simplicity 510(k) for its Wolffs Law Anterior Cervical Plate System.
FDA warns Malaysias TCT Neutraceuticals about CGMP violations in its manufacturing of OTC drugs.
Federal Register notice: CDER announces the Emerging Drug Safety Technology Meeting program for stakeholders to discuss the use of artificial intellig...
Insulet recalls (Class 1) its Omnipod DASH Insulin Management Systems Personal Diabetes Manager after receiving reports battery issues.
FDA warns Boca Raton, FL-based Cosmetic Solutions about CGMP and unapproved new drug violations in its manufacturing of finished drugs.
The Office of Pharmaceutical Quality FY 2023 annual report says drug quality assurance inspections were up 40% over FY 2022 and mutual recognition agr...
