iHealth Labs, a subsidiary of China-based medical device company Andon Health, has received FDA clearance for a wireless fingertip pulse oximeter, which will be a distinct offering from the consumer ...
Hong Kong-based startup PanopticAI has obtained regulatory approval in the United States for its contactless pulse rate measuring application. It received the US Food and Drug Administration's 510(k) ...
The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical ...
PHOENIX--(BUSINESS WIRE)--Mindset Medical, Inc. (“Mindset Medical” or the “Company”), a digital health company, today announced FDA 510(k) clearance for its contactless pulse rate measurement device, ...