HeartBeam (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (“VECG”) platform for heart attack detection anytime, anywhere, is partnering with medical device manufacturing company Evolve Manufacturing Technologies to build its credit-card-sized AIMIGo(TM) 3D vector electrocardiogram (“VECG”) recording device; the device is designed to provide a 12-lead ECG readout to detect heart attacks remotely. According to the announcement, HeartBeam will leverage Evolve’s manufacturing and packaging expertise as it focused on commercializing its HeartBeam AIMIGo device; the company expects to receive FDA clearance for the device in early 2023 and will then begin early market testing. “Evolve has deep medical device manufacturing expertise and a strong reputation in the industry for delivering consistent product quality and customer care rarely found in medical contract manufacturers,” said HeartBeam founder and CEO Branislav Vajdic, PhD, in the press release. “Evolve’s dedicated customer teams use Design for Excellence (‘DFX’) methodologies, and state-of-the-art, end-to-end quality processes, plus world-class materials suppliers to ensure consistent and high-quality products. We have now begun technology transfer from Triple Ring Technologies to Evolve as they develop and obtain experience with our product in preparation for manufacturing. With our successful five-phase device technology development project with Triple Ring nearing completion, we are advancing towards precommercial production. We believe Evolve’s long-standing collaborative relationship with Triple Ring will greatly benefit HeartBeam in expediting technology transfer through commercial production once we have received FDA clearance for AIMIGo, estimated for the first quarter of 2023.”
To view the full press release, visit https://nnw.fm/42EcS
About HeartBeam Inc.
HeartBeam is a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, anywhere. By applying a suite of proprietary algorithms to simplify vector electrocardiography (“VECG”), the HeartBeam platform enables patients and their clinicians to determine quickly and easily if symptoms are due to a heart attack so care can be expedited if required. HeartBeam has two patented products in development. HeartBeam AIMI(TM) is software for acute care settings that provides a 3D comparison of baseline and symptomatic 12-lead ECG to identify a heart attack more accurately. HeartBeam AIMIGo(TM) is the first and only credit-card-sized, 12-lead output ECG device coupled with a smart phone app and cloud-based diagnostic software system to facilitate remote heart-attack detection. HeartBeam AIMI and AIMIGo have not yet been cleared by the U.S. Food and Drug Administration (“FDA”) for marketing in the United States or other geographies. For more information, visit www.HeartBeam.com.
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