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FAQ: HeartBeam's Regulatory Strategy After FDA's NSE Decision on ECG Synthesis Software
TL;DR
HeartBeam's FDA appeal strategy for its 12-lead ECG software could accelerate market entry, giving investors a potential advantage in the cardiac monitoring sector.
HeartBeam plans to pursue parallel regulatory paths including a formal appeal or resubmission after FDA concerns about its 12-lead ECG synthesis software.
HeartBeam's portable 3D ECG technology enables remote cardiac monitoring, improving access to care and potentially saving lives outside medical facilities.
HeartBeam's cable-free device creates 3D ECG signals from three dimensions, synthesizing them into actionable 12-lead readings for portable cardiac assessment.
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HeartBeam Inc. is detailing its regulatory strategy after receiving a Not Substantially Equivalent (NSE) decision from the FDA for its 510(k) submission covering its 12-lead ECG Synthesis Software.
HeartBeam is creating the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar dimensions and synthesizing the signals into a 12-lead ECG, designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence.
The FDA issued a Not Substantially Equivalent (NSE) decision for HeartBeam's 510(k) submission covering its 12-lead ECG Synthesis Software.
HeartBeam plans to pursue multiple parallel paths including a formal appeal or a 510(k) resubmission, with recent interactions indicating a viable path forward under the appeal option which carries an expected 60-day timeline.
HeartBeam's VALID-ECG clinical study met its endpoints, and the company believes remaining FDA concerns may be resolved through revised labeling.
HeartBeam has been in active discussions with FDA review staff, who have signaled willingness to work toward a constructive resolution.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024.
HeartBeam holds over 20 issued patents related to technology enablement.
The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT.
This platform technology allows physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility, potentially redefining the future of cardiac health management.
Curated from InvestorBrandNetwork (IBN)
