Huxley Medical, Inc. announced the SANSA(R) home sleep apnea test has received regulatory clearance from the United States Food and Drug Administration (FDA) to be used as a diagnostic ECG monitor, ...
The US Food and Drug Administration (FDA) has granted 510(k) regulatory clearance to the Curvus Arrhythmia Monitoring Device (C-AD), a wireless-enabled and continuous tracker of real-time ECG readings ...
New York-based Peerbridge Health announced that its wireless device, dubbed the Peerbridge Cor System, is the latest ECG device to receive 510(k) clearance from the FDA. According to the company, the ...
FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients ...
HeartBeam BEAT recently secured FDA 510(k) clearance for its first-of-its-kind, cable-free synthesized 12-lead ECG technology, marking a major inflection point in the company’s mission to modernize ...
HeartBeam, Inc. (BEAT) (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that the U.S. Food and Drug ...
HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that the U.S. Food and Drug ...
FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients ...