HeartBeam, Inc. (BEAT)

HeartBeam's stock price has been impacted by several significant events over the past six months. On November 21, 2025, the stock slumped after receiving a "Not Substantially Equivalent" (NSE) letter from the FDA. On November 26, 2025, HeartBeam announced its regulatory strategy following the NSE decision. On December 10, 2025, the FDA granted 510(k) clearance for its 12-lead ECG synthesis software, leading to a surge in the stock price. In December 2024, the HeartBeam System received FDA 510(k) clearance for comprehensive arrhythmia assessment. On January 5, 2026, HeartBeam announced its attendance at the JP Morgan 2026 Annual Healthcare Conference. On January 9, 2026, HeartBeam's 12-lead ECG synthesis software was highlighted in a Modern Healthcare report.

There is no specific information available to indicate significant demand seasonality for HeartBeam, Inc.'s products and services. Demand is likely driven by ongoing healthcare needs rather than seasonal fluctuations.

HeartBeam, Inc., founded in 2015 and based in Santa Clara, California, is a medical technology company focused on transforming cardiac condition detection and monitoring through innovative, remote diagnostic technologies. Their flagship technology is a proprietary vector electrocardiography (VECG) platform, featuring a credit card-sized device that captures ECG signals in 3D and synthesizes them into a 12-lead ECG. HeartBeam's products are designed for portable use, enabling patients to capture high-fidelity heart data during symptomatic episodes, and include cloud-based diagnostic software for heart attack detection and cardiac monitoring. The company aims to deliver actionable heart intelligence, enabling physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care remotely, and holds over 20 issued patents related to its technology.

HeartBeam, Inc.'s initial geographic market is the United States, targeting concierge physicians, cardiology practices, and hospital cardiology departments as primary customers. Healthcare insurers are also considered important customers due to the potential for reduced healthcare system costs.

HeartBeam has received positive recognition and awards in the past year. In March 2025, the company was awarded the Diamond Pinnacle Healthcare Award in Medical Device Innovation. In September 2025, HeartBeam was recognized as a finalist at the 2025 Octane High Tech Awards and received the Innovation Award in Remote Cardiac Diagnostics as part of the 2025 Medical Device Network Excellence Awards. In November 2025, HeartBeam was recognized as a Global IP and Technology Leader in Portable Cardiac Diagnostics. In October 28, 2025, HeartBeam partnered with HeartNexus, Inc. The "Not Substantially Equivalent" (NSE) letter from the FDA in November 2025 temporarily impacted its reputation, but the company successfully appealed this decision, and the FDA granted 510(k) clearance in December 2025.

HeartBeam, Inc. is owned by a mix of institutional shareholders (9.72%), insiders (16.92%), and retail investors (73.37%). Major institutional owners include Vanguard Group Inc., VTSMX, VEXMX, Smith, Salley & Associates, Geode Capital Management, Llc, UBS Group AG, Kestra Private Wealth Services, Llc, Ritholtz Wealth Management, O'shaughnessy Asset Management, Llc, and FSMAX. Key individual and insider owners include Mark E. Strome, Branislav Vajdic, Christopher A. Marlett Living Trust, and Andrew Schwartzberg. Strome Investment Management, L.P. / Strome Mezzanine Fund II, LP, and Public Ventures, LLC are also major shareholders.