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Posted On: 01/29/2025 5:36:08 PM
Post# of 175
NetworkNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Submits FDA Application for 12-Lead ECG Synthesis Software
HeartBeam (NASDAQ: BEAT), a medical technology company advancing cardiac care, has submitted a 510(k) application to the U.S. Food and Drug Administration (“FDA”) for its 12-lead electrocardiogram (“ECG”) synthesis software. The software is designed to assess cardiac rhythms and arrhythmias, including atrial fibrillation, atrial flutter, bradycardia, and tachycardia. The submission is supported by data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites and demonstrated clinical equivalence to standard 12-lead ECGs. HeartBeam recently secured FDA clearance for its patented technology that captures heart signals from three directions and synthesizes them into a traditional 12-lead ECG format. Upon approval, the company plans a commercial launch informed by its Early Access Program, which has already attracted strong physician and patient interest. CEO Robert Eno highlighted the software’s potential to transform cardiac monitoring outside medical facilities. Future advancements include AI-driven classification algorithms and heart attack detection to reduce “symptom to door” times, a key focus for the American Heart Association.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
HeartBeam (NASDAQ: BEAT), a medical technology company advancing cardiac care, has submitted a 510(k) application to the U.S. Food and Drug Administration (“FDA”) for its 12-lead electrocardiogram (“ECG”) synthesis software. The software is designed to assess cardiac rhythms and arrhythmias, including atrial fibrillation, atrial flutter, bradycardia, and tachycardia. The submission is supported by data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites and demonstrated clinical equivalence to standard 12-lead ECGs. HeartBeam recently secured FDA clearance for its patented technology that captures heart signals from three directions and synthesizes them into a traditional 12-lead ECG format. Upon approval, the company plans a commercial launch informed by its Early Access Program, which has already attracted strong physician and patient interest. CEO Robert Eno highlighted the software’s potential to transform cardiac monitoring outside medical facilities. Future advancements include AI-driven classification algorithms and heart attack detection to reduce “symptom to door” times, a key focus for the American Heart Association.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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