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. develops medical technology for ambulatory cardiac monitoring, centered on a patented cable-free 3D ECG platform that captures signals from three non-coplanar dimensions and synthesizes a 12-lead ECG. News commonly covers the FDA-cleared HeartBeam System for arrhythmia assessment, limited commercial launch activity, preventive cardiology and concierge practice deployments, AI-ECG collaboration, and development of on-demand patch and heart attack detection initiatives.
Corporate updates also include financial results and common-stock financing used to support commercialization, product development, AI capabilities, working capital, and general corporate purposes.
HeartBeam (NASDAQ: BEAT) said management will attend investor and industry conferences in March 2026 to provide commercial-launch updates and product demonstrations.
Key events: Oppenheimer MedTech & Services (virtual) March 16-17 with a March 16 webcast; ROTH Conference (Dana Point) March 23-24; ACC.26 (New Orleans) March 28-30 with booth #209. The FDA-cleared HeartBeam System will be demoed and a working 12-lead ECG extended wear patch prototype (not FDA-approved) will be shown to physicians and partners.
HeartBeam (NASDAQ: BEAT) announced first patient enrollments in the ALIGN-ACS pilot study for heart attack detection on March 5, 2026. The study will compare HeartBeam’s 3D ECG device with standard 12-lead ECGs in ER chest-pain patients to inform a multicenter pivotal study and potential FDA indication expansion.
The pilot aims to enroll 100 ER chest-pain patients, build on prior 3D ECG proof-of-concept results, and accelerate symptom-to-door assessment by enabling clinical-grade ECG capture outside hospitals.
HeartBeam (NASDAQ: BEAT) will host a conference call on Thursday, March 12, 2026 at 4:30 p.m. Eastern to discuss fourth-quarter and full-year 2025 results and strategic updates on the 12-lead ECG extended wear patch. A presentation and short video will accompany the webcast and will be available afterward in investor relations.
HeartBeam (NASDAQ: BEAT) announced its first commercial customer: ClearCardio, a preventive cardiology practice that will integrate HeartBeam’s synthesized 12-lead ECG technology into its member prevention programs.
The agreement is an initial staged rollout under a Letter of Intent, includes a planned ClearCardio investment, targets replication across concierge and executive health networks, and references a structured direct-pay segment representing 5 million patients.
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).