BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Advances Toward Commercialization of Cardiac Care Technology with FDA Submissions and Key Leadership Appointments
HeartBeam (NASDAQ: BEAT), reported steady progress in its third quarter financial and operational results, advancing its cardiac care technology through key FDA 510(k) submissions and strategic leadership appointments. The company’s first FDA 510(k) submission for the HeartBeam system is actively under review, with HeartBeam responding to FDA inquiries and preparing for an Early Access Program post-clearance. Following this, HeartBeam plans to submit a second 510(k) application focused on its 12-lead ECG synthesis software. New CEO Robert Eno, along with other senior management hires, aims to guide the company toward U.S. commercialization. HeartBeam has also amassed significant clinical evidence supporting its…
