Browsing: 510k

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…

EndoTool IV Cloud is the first FDA-cleared, cloud-based patient-specific insulin dosing platform, designed to support scalable deployment Commercial launch anticipated…

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…

Welldoc Builds on its Foundation of 11 Prior FDA 510(k) Clearances with a Generative AI Model Submission COLUMBIA, Md.–(BUSINESS WIRE)–Welldoc®,…

Clearance Expands vMap’s Non-Invasive Mapping Capabilities with Direct ECG Data Streaming, Software-Only Deployment and 3D Model Import Tools SAN DIEGO–(BUSINESS…

CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–Aptar Digital Health, a global leader in digital health solutions enhancing the patient experience, today announced that…