Browsing: Clearance

By the numbers   Q1 27 revenue: $843 million 17% increase year over year Following the debut of its smallest…

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

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

What You Should Know Philips has officially secured U.S. FDA 510(k) clearance for its next-generation reusable SpO₂ clip sensor.In controlled…

Dive Brief: Philips received 510(k) clearance for a new version of its pulse oximeter clip sensor that the company says…

Going by leaks and what Samsung has teased so far, we’re pretty confident that the Samsung Galaxy Watch 9 is…

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