Browsing: receives

What You Should Know Oxford spin-out Caristo Diagnostics has secured FDA De Novo authorization for CaRi-Heart®, making it the first…

What You Should Know Medical AI developer ThinkSono has secured FDA 510(k) clearance for ThinkSono Guidance, the first AI-powered ultrasound…

Zoll received a warning letter from the Food and Drug Administration citing quality concerns and problems with how the firm…

Allows for Commercial Deployment of the Company’s Radiation-Free Breast Imaging Technology Under Distribution Agreement with Gulf Medical Co. NOVATO, Calif.–(BUSINESS…

Dive Brief: Abbott has received Europe’s CE mark for the first dual-analyte sensor that can measure both glucose and ketones,…

Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected. Medline…

What You Should Know The Milestone: Butterfly Network has received FDA clearance for a fully automated Gestational Age (GA) Tool…

Dive Brief: Dive Insight: The FDA sent the warning letter after an inspection of Exactech’s Sarasota, Florida, facility in July.…

What You Should Know: The Clearance: GE HealthCare has officially received FDA 510(k) clearance for View, a fast, zero-footprint diagnostic…

Listen to the article 2 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief:…