Roth sees potential FDA clearance for HeartBeam despite letter

Roth Capital keeps a Buy rating on HeartBeam (BEAT) with a $4 price target after the company received a “not substantially equivalent” letter from the FDA regarding its 510(k) application for its 12-lead electrocardiogram synthesis software. Roth believes the FDA may want the company to use a different predicate device, pursue a different regulatory pathway, or provide additional data. While resolving the pathway for the 12-lead ECG synthesis software, management may decide to roll out the foundational 3D ECG system to concierge medical practices, preventive cardiology clinics, and hospital-at-home programs, the analyst tells investors in a research note. Roth continues to believe HeartBeam’s technology can fill an unmet need ahead of eventual clearance of its synthesized 12-lead ECG system.