HeartBeam, Inc. (BEAT)

HeartBeam's stock price has been significantly impacted by regulatory news. In November 2025, shares slumped by 58% after the FDA issued a "Not Substantially Equivalent" letter for its 12-Lead ECG Synthesis Software, followed by a further decline of 64.9% the following week. Despite the FDA setback, HeartBeam announced its regulatory strategy, leading to a surge of over 40% in after-hours trading on November 27, 2025. In December 2024, HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment. HeartBeam reported its third-quarter 2025 results, highlighting progress toward commercialization of its 12-lead ECG synthesis software and announced a partnership with HeartNexus. Overall, the stock has dropped 74.31% year-to-date and approximately 79.19% over the past year.

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HeartBeam, Inc. is a medical technology company focused on transforming cardiac care through advanced ECG solutions, operating within the Healthcare sector, specifically in the Health Technology sector and Medical Specialties and Healthcare Providers & Services industries. The company develops and commercializes higher-resolution ambulatory ECG solutions for detecting and monitoring cardiac disease. HeartBeam's core innovation is its VECG technology platform, which enables the creation of a cable-free device capable of collecting ECG signals in 3D and synthesizing them into a 12-lead ECG. Major products include the HeartBeam System, a portable ECG recorder; HeartBeam AIMIGo, a cloud-based diagnostic software for heart attack detection; HeartBeam AIMI, an ED product; 3D ECG technology, which received FDA clearance for arrhythmia assessment in December 2024; and 12-Lead ECG Synthesis Software, designed to synthesize 12-lead ECG recordings from 3-lead 3D VECG signals.

The initial geographic market for HeartBeam's telehealth products (HeartBeam AIMIGo) and ED Products (HeartBeam AIMI) is the United States. The company is headquartered in Santa Clara, California.

HeartBeam has been recognized for its innovation in cardiac diagnostics, receiving the 2025 Innovation Award in Remote Cardiac Diagnostics and ranking #2 worldwide in 12-lead ECG innovation. Its deep learning algorithms have demonstrated high accuracy for detecting arrhythmias, and the company has expanded its global intellectual property portfolio. However, the FDA's "Not Substantially Equivalent" decision in November 2025 negatively affected the brand reputation in the short term, causing a significant stock slump, though the company is actively engaging with the FDA to resolve concerns.

HeartBeam, Inc. has 50 institutional owners and shareholders holding a total of 3,634,765 shares, including major holders like Vanguard Group Inc., VTSMX, VEXMX, Smith, Salley & Associates, Geode Capital Management, Llc, and UBS Group AG. Insider ownership is relatively low at 5.73%.