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) develops portable cardiac monitoring devices using proprietary 3D vectorcardiography technology to synthesize diagnostic-quality 12-lead electrocardiograms. This news page provides coverage of regulatory developments, clinical study results, commercialization progress, and corporate announcements affecting the company's medical technology business.
News coverage for HeartBeam typically focuses on several key areas. FDA regulatory decisions significantly impact the company's ability to market its products, making announcements of 510(k) clearances, clinical study submissions, and regulatory correspondence particularly newsworthy. Clinical trial results demonstrating the diagnostic accuracy of the company's synthesized ECG technology compared to traditional systems influence physician adoption and investor confidence. Partnership announcements with cardiology practices, concierge medicine networks, or remote monitoring platforms signal commercialization progress.
As a development-stage medical device company, HeartBeam's news flow also includes corporate financing activities such as public offerings, private placements, or strategic investments that fund product development and market expansion. Intellectual property developments including new patent grants, licensing agreements, or patent litigation can affect the company's competitive position in the portable cardiac monitoring market.
Industry developments in remote patient monitoring, Medicare reimbursement policies for cardiac diagnostic services, and broader trends in digital health adoption provide context for understanding HeartBeam's market opportunity. Competitive announcements from other portable ECG device manufacturers and acquisitions in the cardiovascular technology sector may influence HeartBeam's strategic direction and market valuation.
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.
HeartBeam (NASDAQ: BEAT), a medical technology company specializing in cardiac care solutions, has scheduled its Q2 2025 earnings conference call for August 13, 2025, at 4:30 p.m. Eastern time. The call will be led by CEO Robert Eno and CFO Timothy Cruickshank, who will discuss second quarter results and provide updates on regulatory initiatives and commercial activities.
The earnings release will be issued before the call, which will include a presentation accessible through the company's investor relations website. Participants can join via phone using U.S. dial-in 1-844-826-3035 or international dial-in 1-412-317-5195 with conference code 10201583. A webcast will also be available, and a replay will be accessible until November 13, 2025.
HeartBeam (NASDAQ: BEAT) has been awarded the Innovation Award in Remote Cardiac Diagnostics at the 2025 Medical Device Network Excellence Awards for its groundbreaking FDA-cleared ECG technology. The company's proprietary technology captures heart electrical signals in 3D non-coplanar directions and synthesizes them into a 12-lead ECG using a credit card-sized, cable-free device.
The technology enables clinical-grade diagnostics for arrhythmia assessment outside traditional healthcare settings, allowing patients to record symptoms as they occur. HeartBeam's 12-lead ECG synthesis software is currently under FDA review, with commercialization planned upon clearance. The company has previously received multiple industry recognitions, including the Pinnacle Healthcare Award and MedTech Breakthrough Award.
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