Browsing: FDA Clearance

What You Should Know The U.S. Food and Drug Administration (FDA) has cleared a new Apple Watch-based monitoring tool developed…

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

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

What You Should Know The Milestone: GE HealthCare has officially received FDA 510(k) clearance for Photonova Spectra, its highly anticipated…

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

What You Should Know – AliveCor, the global leader in AI-powered cardiology, has received U.S. FDA clearance for the next…

What You Should Know – AccurKardia has announced its second FDA 510(k) clearance for the AccurECG™ Analysis System (v2.0). This…