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, Inc. (NASDAQ: BEAT) announced the issuance of a patent for its AIMIGo™ device, enabling a synthesized 12-lead ECG outside medical settings. This innovation allows patients to send heart signal data directly to physicians, enhancing heart attack detection. With around 18 million individuals in the US at risk for heart attacks, the technology addresses a significant healthcare need. HeartBeam's AIMIGo is the only wallet-sized 12-lead ECG solution, aiming to reduce emergency visits and expedite care while improving patient quality of life.
HeartBeam, Inc. (NASDAQ: BEAT) announced a virtual roadshow webinar set for
HeartBeam, Inc. (NASDAQ: BEAT) has received a patent for its innovative 12-lead ECG patch monitor, which allows for the detection of acute coronary syndrome and cardiac arrhythmia outside medical settings. This technology enhances traditional ECG diagnostics, contributing to a projected global market of
HeartBeam, Inc. (NASDAQ: BEAT) has announced a virtual roadshow webinar on September 20, 2022, at 4:30 p.m. ET. During this event, a new video showcasing the HeartBeam AIMIGo technology for heart attack detection will be unveiled. While the AIMI and AIMIGo technologies are pending FDA clearance, they aim to enhance heart attack detection outside of medical settings. The webinar will feature CEO Branislav Vajdic and other executives discussing the company’s milestones and 510(k) application progress. Access the webinar via the provided link.
HeartBeam, Inc. (NASDAQ: BEAT) has submitted a 510(k) application to the US FDA for its HeartBeam AIMI™ technology, aimed at improving heart attack diagnosis. This step is crucial for the company's commercialization efforts within a
HeartBeam, Inc. (NASDAQ: BEAT) reported its Q2 2022 financial and operational results, highlighting significant advancements towards FDA submissions for its HeartBeam AIMI™ software platform and AIMIGo™ telehealth solution. The company plans to submit the AIMI platform for FDA clearance around August 15, 2022, and aims for AIMIGo submission in Q4 2022. Q2 net loss was $3.5 million, with cash reserves at $9.3 million. HeartBeam expanded its target patient population by including unstable angina, enhancing the platform's clinical validation study scope.
HeartBeam, Inc. (NASDAQ: BEAT) announced the appointment of Ken Persen as Chief Technology Officer, bringing over 25 years of experience in digital healthcare and cardiac devices. Persen will lead the technology strategy and development of the HeartBeam AIMI™ and AIMIGo™ platforms, enhancing the company's innovative ECG telemedicine technology. This appointment aims to improve the management of heart attack symptoms outside medical institutions, addressing a significant market need.
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HeartBeam, Inc. (NASDAQ: BEAT) will host a conference call on
HeartBeam, Inc. (NASDAQ: BEAT) announced an expansion of its clinical validation study to include a broader patient population for its emergency department software technology. The decision follows the recent AHA guidelines and aims to include unstable angina patients, which may enhance heart attack detection. HeartBeam plans to file a 510K submission by August 15, 2022, which remains unaffected by the Telehealth product's timeline, scheduled for Q4 2022. This expanded scope aligns with their goal of improving cardiovascular diagnosis.