Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its NIM Vital, and it’s acquired Ai Biomed. NIM Vital is an intraoperative nerve monitoring system designed to allow physicians to identify, confirm and monitor nerve function in an effort to reduce the risk of nerve damage during head and neck surgery, according to a […]
aibiomed
FDA grants de novo clearance to AI Biomed, FluoOptics parathyroid tissue detection devices
The FDA today granted de novo clearance to parathyroid tissue detection devices from both Fluoptics and AI Biomed. The systems are intended to provide the real-time location of parathyroid tissue during surgical procedures including thyroidectomy and parathyroidectomy, the federal watchdog said. FluOptics won approval for its Fluobeam 800 clinic imaging device which can be used […]
