HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application ...

HeartBeam (BEAT) announced its regulatory strategy following receipt of a Not Substantially Equivalent, or NSE, decision on the company’s 510(k) ...

A 52-year-old man hospitalized with chest pain is found to have a slow heart rate and evidence of heart block. What does an ...

A 94-year-old female with history of hypertension, chronic kidney disease, and hyperlipidemia presents to the emergency ...

Thank you, operator. HeartBeam is dedicated to developing groundbreaking ECG technology for patients to use at home, to allow them to feel confident about their heart health. HeartBeam is developing ...

Recognized As A Top Global Innovator In Portable ECG Technology. <li /> The company was ranked second worldwide out of 243 companies evaluated in 12-lead ECG innovation in PatentVest's“Total Cardiac ...

HeartBeam (NASDAQ: BEAT) is on the verge of transforming how atrial fibrillation (“AF”) is detected and managed with its ...

HeartBeam (NASDAQ: BEAT) reported third-quarter 2025 results and highlighted continued progress toward commercialization of its 12-lead ECG synthesis software, now in the final stage of FDA 510 (k) ...

HeartBeam is pursuing several parallel paths to address the FDA’s concerns, including a potential appeal process or resubmission of a 510 (k) application. The company noted that the appeal process ...

Reports Q3 2025 Results As FDA Review Nears Completion And Commercial Readiness Accelerates. HeartBeam (NASDAQ: BEAT) reported third-quarter 2025 results and highlighted continued progress toward ...

ADInstruments Lt educational platform provides pre designed laboratory exercises that incorporate physiological data acquisition, allowing students to perform ECG recordings while learning proper ...

The company said it will work with the agency to reach a resolution and expressed confidence in its clinical data.