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.
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