MINNEAPOLIS, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Sleepiz, a Zurich-based medical technology company providing contactless bedside patient monitoring, today announces the FDA Class II 510(k) clearance of ...
Neuralink, the Elon Musk-owned brain-computer interface company, on Tuesday received “breakthrough device” clearance from the FDA. But this does not mean the outfit has developed a cure for blindness, ...
FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA?
Inogen, Inc. INGN recently announced the FDA 510(k) clearance for the SIMEOX 200 Airway Clearance Device. The clearance is likely to expand INGN’s ability to market the device and meet the various ...
Calif.-based DyAnsys, a medical device company specializing in the autonomous nervous system, announced Primary Relief, its percutaneous electrical nerve stimulator (PENS) system, received approval by ...
BrainsWay’s deep transcranial magnetic stimulation (Deep TMS) system is a best-in-class device designed to maximize electromagnetic stimulation of deep and broad brain regions, helping to launch a new ...
Teleflex Incorporated announced the FDA 510(k) clearance for an expansion of the QuikClot Control+™ Hemostatic Device's indications, now including all grades of internal and external bleeding.
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