Tag: 510(k) clearance
LivaNova receives FDA 510(k) approval for new in-line blood monitor
Editor's Note The Essenz™ In-Line Blood Monitor (ILBM) has received U.S. FDA 510(k) clearance and CE mark, as announced by manufacturer LivaNova on August 30. The new ILBM provides “accurate and continuous measurement of essential blood parameters for perfusionists throughout cardiopulmonary bypass procedures,” and integrates with the company’s Essenz Perfusion…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
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