Abstract: Ballistocardiography (BCG) is a non-invasive method to assess cardiac activity by detecting body recoil in response to heart contractions and blood flow. Traditionally, BCG technology was ...
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 ...
After receiving word late last month that the FDA would not be issuing a 510(k) clearance to its cable-free electrocardiogram, HeartBeam has successfully appealed the decision and now touts a green ...
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, 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 ...
SANTA CLARA, Calif., December 10, 2025--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, ...