Welcome to our dedicated page for Heartbeam news (Ticker: BEAT), a resource for investors and traders seeking the latest updates and insights on Heartbeam stock.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company that regularly issues updates on its cardiac monitoring platform, regulatory milestones, and commercialization plans. Company news highlights its focus on transforming cardiac care through portable, cable-free ECG technologies that can be used by adult patients in clinical settings or at home for arrhythmia assessment.
News releases frequently cover developments related to HeartBeam’s 3D ECG technology and 12-lead ECG synthesis software. These include FDA 510(k) clearance for arrhythmia assessment, the regulatory path for the 12-lead synthesis software, and the company’s responses to a Not Substantially Equivalent (NSE) decision and subsequent successful appeal. Investors can also find updates on clinical studies such as the VALID-ECG study and deep learning research presented at conferences like HRX Live, which examine how HeartBeam’s algorithms perform in detecting atrial fibrillation, atrial flutter, and sinus rhythm.
HeartBeam’s news flow also addresses commercial readiness, including plans for limited U.S. launch with concierge and preventive cardiology practices, establishment of a cardiology reader service, and infrastructure for customer service, contract manufacturing, and logistics. Announcements about the partnership with HeartNexus, Inc. describe how synthesized 12-lead ECGs from HeartBeam’s system will be reviewed by a network of board-certified cardiologists, supporting arrhythmia assessment and patient triage outside traditional healthcare facilities.
In addition, periodic earnings releases and conference participation notices provide insight into the company’s operating expenses, cash position, and engagement with investors and industry partners. Visitors to this news page can review these updates to understand how HeartBeam is progressing on regulatory, clinical, and commercialization objectives for its cardiac monitoring technologies.
HeartBeam (NASDAQ: BEAT) appointed Bryan Humbarger as Chief Commercial Officer, effective January 22, 2026. Humbarger brings more than 25 years of commercial leadership in cardiovascular and MedTech firms and will lead the company’s commercialization for its recently FDA-cleared 12-lead ECG system for arrhythmia assessment. His remit includes directing a limited launch, developing partnerships with channel partners and cardiology practices, validating real-world performance through reference sites, and advancing initiatives for heart attack detection and a 12-lead extended-wear ECG patch.
This role is newly created to scale commercial strategy and execute initial market introduction while building sales and clinical support infrastructure.
HeartBeam (NASDAQ: BEAT) will attend the JP Morgan 2026 Annual Healthcare Conference on January 12-15, 2026 with management available for off-site meetings January 12-14. The company announced it recently received FDA 510(k) clearance for a first-ever cable-free synthesized 12-lead ECG for at-home arrhythmia assessment that captures signals in three non-coplanar dimensions and synthesizes a 12-lead ECG. Readings are reviewed by an on-demand, board-certified cardiologist. HeartBeam plans a limited U.S. commercial launch in Q1 2026 with select concierge and preventive cardiology practices that signaled adoption interest. The company said broader rollout, wearable integration, AI-enabled insights, and its heart attack detection program will be announced later.
HeartBeam (NASDAQ: BEAT) announced FDA 510(k) clearance for its cable-free synthesized 12-lead ECG software for at-home arrhythmia assessment on December 10, 2025, following a successful appeal of a prior Not Substantially Equivalent determination. The device captures 3D cardiac signals and synthesizes a clinical-grade 12-lead ECG, with readings reviewed by on-demand board-certified cardiologists.
The company plans a limited U.S. launch in Q1 2026 targeting concierge and preventive cardiology groups, and intends to advance heart attack detection efforts, an extended-wear 12-lead patch prototype, and longitudinal AI screening built on its 3D ECG data.
HeartBeam (NASDAQ: BEAT) provided an update on its regulatory path after receiving a Not Substantially Equivalent (NSE) decision from the FDA for its 12‑lead ECG Synthesis Software on November 26, 2025. The company says its supporting clinical study (VALID‑ECG) met agreed endpoints and believes outstanding FDA concerns can be addressed via labeling modifications. HeartBeam is pursuing multiple parallel options, including an appeal or 510(k) resubmission, and the firm says recent FDA discussions indicate a constructive path forward. The company notes the official appeal timeline is approximately 60 days from submission to resolution and will provide updates on commercial launch and funding plans.
HeartBeam (NASDAQ: BEAT) reported Q3 2025 results and operational progress ahead of an anticipated FDA 510(k) clearance for its 12‑lead ECG synthesis software expected in Q4 2025, which the company says would mark a transition to commercial stage and enable launch activities.
Key developments include a partnership with HeartNexus for on‑demand cardiologist reviews, new data presented at AHA and HRX Live, three patents issued (total 24 worldwide), ROTH Capital initiating coverage with a Buy and $4 target, and cash and cash equivalents of $1.9M as of September 30, 2025.
HeartBeam (NASDAQ: BEAT) will host a conference call on Thursday, November 13, 2025 at 4:30 p.m. Eastern to discuss third quarter results for the period ended September 30, 2025, and to provide updates on regulatory initiatives, commercial-readiness activities and anticipated milestones.
CEO Robert Eno and CFO Timothy Cruickshank will present, followed by Q&A. A press release with results will be issued prior to the call and a presentation will accompany the webcast; the presentation will be available via the investor relations website after the call.
Dial-in details: U.S. 1-844-826-3035, international 1-412-317-5195, conference code 10203405. Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1737162&tp_key=207a793b93. Telephone replay available ~three hours after the call through February 13, 2025 at U.S. 1-844-512-2921 (replay PIN 10203405).
HeartBeam (NASDAQ: BEAT) announced a partnership with HeartNexus to offer a 24/7 cardiology reader service that delivers cardiologist-level ECG interpretation for patients outside traditional care settings.
Patients will capture a 30-second recording with HeartBeam’s credit-card-sized, cable-free device; its patented 3D technology synthesizes a 12-lead ECG that is securely transmitted to board-certified cardiologists for immediate review and feedback to the patient or clinician.
The cardiology reader service is planned to launch after the company’s anticipated FDA clearance of its 12-lead ECG synthesis software, which HeartBeam continues to expect in Q4 2025. Future ecosystem enhancements may include AI wellness, community features, and wearable integration.
HeartBeam (NASDAQ: BEAT) announced promising results from a new study demonstrating the effectiveness of their deep learning algorithms in detecting cardiac arrhythmias. The study, presented at HRX Live 2025, showed that HeartBeam's AI algorithms achieved 94.5% accuracy when used with their credit card-sized 3D ECG system, comparable to the 95.5% accuracy with standard 12-lead ECGs.
The study involved 201 patients and evaluated the detection of atrial fibrillation, atrial flutter, and sinus rhythm. The algorithms, developed from over 10,000 standard 12-lead ECGs, will be used to support future FDA submissions to enhance HeartBeam's product offerings.
HeartBeam (NASDAQ: BEAT), a medical technology company specializing in cardiac care, announced its participation in three major industry conferences in September 2025. CEO Robert Eno and CFO Timothy Cruickshank will attend the MDB Investor Summit (September 4), HRX Live 2025 (September 4-6), and H.C. Wainwright Global Investment Conference (September 8-10).
The company will showcase its FDA-cleared HeartBeam System, a cable-free, credit card-sized device that collects 3D ECG signals for arrhythmia assessment. At HRX Live, Dr. Joshua Lampert from Mount Sinai Heart will present new data comparing HeartBeam's AI algorithm performance for detecting atrial flutter and fibrillation.
HeartBeam (NASDAQ: BEAT) reported Q2 2025 financial results and provided updates on its commercial readiness plans. The company's pivotal VALID-ECG study demonstrated 93.4% overall diagnostic agreement for its 12-lead ECG synthesis software. HeartBeam continues productive FDA discussions, expecting 510(k) clearance by year-end.
Financial highlights include $5.1 million in cash and equivalents, with Q2 net loss of $5.0 million. R&D expenses increased to $3.3 million from $2.8 million year-over-year, while G&A expenses decreased to $1.7 million from $2.2 million.
The company expanded its business development team and received two industry recognitions, including the Innovation Award in Remote Cardiac Diagnostics. HeartBeam's patent portfolio now includes 21 issued patents worldwide.