NetworkNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT
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Posted On: 05/18/2023 4:48:41 PM
NetworkNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Announces FDA 510(k) Submission of HeartBeam AIMIGo(TM) Solution
HeartBeam (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D vector electrocardiogram (“VECG”) platform intended for patient use at home, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (“FDA”) for its HeartBeam AIMIGo(TM) System. The HeartBeam AIMIGo System is a personal, portable and easy-to-use VECG solution to assist patients and their clinicians in assessing cardiac symptoms. The breakthrough solution employs a reusable, credit card-sized, VECG recording device and cloud-based software to deliver critical data in real-time outside of a medical setting. “The 510(k) submission of our HeartBeam AIMIGo VECG device is an important milestone for the company,” said Branislav Vajdic, Ph.D., HeartBeam CEO and founder. “We believe that our patented VECG technology holds tremendous promise to provide timely and actionable information to patients and their clinicians. This submission is the result of years of hard work to develop and refine the technology. I am extremely proud of our team and all their efforts to get the product to this stage. We look forward to working with the FDA as they review this application.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
HeartBeam (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D vector electrocardiogram (“VECG”) platform intended for patient use at home, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (“FDA”) for its HeartBeam AIMIGo(TM) System. The HeartBeam AIMIGo System is a personal, portable and easy-to-use VECG solution to assist patients and their clinicians in assessing cardiac symptoms. The breakthrough solution employs a reusable, credit card-sized, VECG recording device and cloud-based software to deliver critical data in real-time outside of a medical setting. “The 510(k) submission of our HeartBeam AIMIGo VECG device is an important milestone for the company,” said Branislav Vajdic, Ph.D., HeartBeam CEO and founder. “We believe that our patented VECG technology holds tremendous promise to provide timely and actionable information to patients and their clinicians. This submission is the result of years of hard work to develop and refine the technology. I am extremely proud of our team and all their efforts to get the product to this stage. We look forward to working with the FDA as they review this application.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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