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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical devices ...
JD Supra9d
FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...
Yahoo Finance12d
Tyber Medical, Intech and Resolve Surgical Technologies combine to form a next-generation solutions provider to the Medical Device industry
an innovative medical device company providing private label development and manufacturing services to med-tech Original Equipment Manufacturers (OEMs). Subject to customary regulatory approvals and ...
MassDevice4d
FDA clears Nalu peripheral nerve stim tech for whole-body MRI
Nalu Medical announced today that the FDA cleared expanded labeling of its peripheral nerve system to include whole-body MRI ...
CPO Magazine12d
White House Launches the Cyber Trust Mark Labeling Program for Consumer Connected Devices
The White House has launched the Cyber Trust Mark labeling program for connected devices to assist consumers in determining ...