TipTraQ is a compact wearable that uses advanced biosensors and AI algorithms to detect sleep apnea events and analyze sleep architecture with clinical-grade accuracy. The device enables patients to ...

Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, today announced new 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Targeted Genomics’ GlutenID test, designed to ...

New World Medical received 510 (k) clearance from the US Food and Drug Administration (FDA) for its VIA360 Surgical System ...

Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use. The single-use blood ...

Hologic (HOLX) announced that the FDA has granted 510(k) clearance for the company’s Aptima SARS-CoV-2 assay, which was first granted Emergency ...

Revolutionising Vascular Access Care for Critically Ill Newborns and Children Key Points: FDA 510(k) Clearance Neonav® ECG Tip Location System is now FDA-cleared, enabling its use in U.S. hospitals to ...

BOSTON--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ...

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Products are independently selected by our editors. We may earn an affiliate commission from links. If you count broccoli, cauliflower, and Brussels sprouts as among your most-frequently eaten ...

Roche announced that it has received FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for the cobas liat sexually transmitted infection (STI) multiplex assay ...