Browsing: receives

Dive Brief: Vara received Europe’s first authorization for an artificial intelligence-enabled system that can autonomously screen mammograms without radiologist review.…

Dive Brief: Kardium said Thursday it will receive up to $31.25 million from the Canadian government to invest in a…

What You Should Know The U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization to Abbott for…

Dive Brief: Abbott has received Food and Drug Administration authorization for a dual-analyte sensor that can measure both glucose and…

What You Should Know The U.S. Food and Drug Administration (FDA) has cleared Roche’s Elecsys® Phospho-Tau (217P) Plasma (pTau217) blood…

What You Should Know CliniComp received U.S. FDA 510(k) clearance for its PACS Viewer as a Medical Image Management and…

What You Should Know DeepHealth, Inc. (a wholly owned subsidiary of RadNet, Inc.) received FDA 510(k) clearance for DeepHealth Breast…

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…