HeartBeam's AI-Powered ECG Device Receives FDA Clearance for At-Home Arrhythmia Assessment

HeartBeam, Inc. Announces FDA Clearance for At-Home, High-Fidelity Heart Monitoring Technology

HeartBeam, Inc. announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment. With its patented design, the HeartBeam device is the first-of-its-kind to receive FDA clearance. As a high-fidelity electrocardiogram (ECG) system with a credit card-sized form factor and cable-free design, it captures heart signals from three distinct directions for actionable heart health information. When a patient feels symptoms, the HeartBeam patient app guides them through the process of placing the device on their chest and capturing a 30-second recording. Once a recording is taken, the signals are sent to the cloud, processed and sent to a physician for review. The physician reviews the ECG recording in the context of the patient's symptoms and medical history, then follows up with the patient on next steps. The Company plans to initiate an Early Access Program and is creating a waitlist of interested patients and physicians. The FDA clearance is foundational and will serve as the basis for future submissions as the Company strives to simplify the access of intelligent and actionable 12-lead ECGs for both patients and physicians. Future planned advances include: Synthesized 12-lead ECG: The HeartBeam system is designed to be capable of synthesizing the heart's signals collected from three directions into a 12-lead ECG using a personalized transformation matrix as demonstrated in this pilot study. AI-Based Classification Al algorithms: Data presented earlier this year demonstrated that HeartBeam's deep learning algorithm has the potential to greatly improve the detection of atrial flutter, evenperforming cardiologists in detecting some arrhythmias. Heart Attack Detection: A study published in JACC: Advances showed that HeartBeam's ambulatory technology is comparable to a standard 12-lead ECG in identifying coronary occlusions and is highly accurate (Area Under the Curve of 95%). Another feasibility study highlighted the potential of HeartBeam's technology to calculate a heart attack risk-score to assess chest pain remotely. HeartBeam's proprietary technology has the potential to unlock valuable diagnostic and predictive insights. The ease of collecting higher-fidelity ECG signals will enable patients to gather a series of recordings over time. The Company aims to leverage AI to analyze this rich set of data, delivering a longitudinal view of a patient's cardiac health and predicting cardiac conditions before symptoms appear. HeartBeam believes its groundbreaking technology presents a transformative opportunity to bring about a paradigm shift in cardiovascular care for millions of patients globally.

FDA clears HeartBeam's novel ECG system for arrhythmia By Investing.com

SANTA CLARA, Calif. - HeartBeam, Inc. (NASDAQ: BEAT), a medical technology firm with a market capitalization of $83.2 million, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its innovative electrocardiogram (ECG) system, designed to enhance cardiac care. The company's stock has shown remarkable momentum, delivering a 149.6% return over the past year according to InvestingPro data. The HeartBeam system, notable for its cable-free, credit card-sized form, is the first of its kind cleared by the FDA for comprehensive arrhythmia assessment. The device allows patients to record an ECG whenever they experience symptoms, potentially reducing delays in care. The HeartBeam patient app assists users in capturing a 30-second ECG by placing the device on their chest. The recorded data are then transferred to the cloud and forwarded to a physician for review, in light of the patient's symptoms and medical history. HeartBeam plans to launch an Early Access Program to gather feedback from patients and physicians ahead of a commercial release. The program aims to refine the use of the system, and the company is currently compiling a waitlist for participation. While the company maintains strong liquidity with a current ratio of 3.31, InvestingPro analysis reveals challenges including rapid cash burn and weak profit margins. Discover 8 additional key insights about HeartBeam's financial health with an InvestingPro subscription. The cleared technology captures heart signals from three directions and is engineered to synthesize these into a 12-lead ECG, which could facilitate remote cardiac assessments. In addition, HeartBeam's deep learning algorithm has shown promise in improving the detection of certain arrhythmias, such as atrial flutter, and studies indicate its potential in identifying coronary occlusions and calculating heart attack risk-scores. HeartBeam's approach leverages artificial intelligence to analyze a rich set of ECG data over time, offering a longitudinal view of cardiac health and the prospect of predicting conditions before symptoms manifest. The company's mission is to revolutionize cardiovascular care management for patients worldwide. The HeartBeam System is intended for adult use, both at home and in clinical settings, and requires manual interpretation of the ECG by a healthcare professional. The device does not perform cardiac analysis independently. This announcement is based on a press release statement from HeartBeam, Inc. The company, with 13 US and 4 international patents, is dedicated to transforming the detection and monitoring of critical cardiac conditions through its platform technology. Trading at $3.12 per share and showing strong momentum with a 32.77% year-to-date return, HeartBeam is one of 1,400+ companies covered by comprehensive InvestingPro Research Reports, offering deep-dive analysis and actionable insights for investors. For more information on the HeartBeam System and its capabilities, please visit the company's website. In other recent news, HeartBeam Inc. disclosed key developments in its Q3 2024 earnings call and subsequent clinical studies. The medical technology firm reported a net loss of $4.979 million for the quarter, despite its advancements in the cardiac care market with its innovative 12-lead ECG technology. HeartBeam is preparing for a limited commercial launch in 2025, pending FDA clearance. HeartBeam's technology was validated in two clinical studies, demonstrating potential to transform cardiac care. One study, an 80-patient pilot, showed the technology's efficacy in arrhythmia detection, while the other evaluated a proprietary algorithm designed to expedite the assessment of chest pain. The company's VALID-ECG study, integral to its FDA submission process, has completed enrollment and data analysis. HeartBeam also highlighted its commitment to financial discipline as it readies for commercialization. These are recent developments that reflect HeartBeam's ongoing efforts to innovate within the cardiac care market.