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FAQ: HeartBeam's Regulatory Strategy After FDA's NSE Decision on ECG Software
TL;DR
HeartBeam's FDA appeal strategy for its 12-lead ECG software could accelerate market entry, giving the company a competitive edge in portable cardiac monitoring technology.
HeartBeam plans parallel regulatory paths including a formal appeal or 510(k) resubmission after receiving a Not Substantially Equivalent decision for its ECG software, with labeling revisions addressing FDA concerns.
HeartBeam's portable 3D ECG technology enables remote cardiac monitoring, potentially improving early detection and access to care for patients outside medical facilities.
HeartBeam's technology creates 12-lead ECGs from three-dimensional signals using a cable-free device, representing a novel approach to portable cardiac assessment.
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HeartBeam 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 cable-free device that collects ECG signals in 3D from three non-coplanar dimensions and synthesizes them into a 12-lead ECG, designed for portable use outside medical facilities to deliver actionable heart intelligence.
The content does not specify the exact reasons for the NSE decision, but notes that remaining FDA concerns may be resolved through revised labeling and that the company's VALID-ECG clinical study met its endpoints.
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 has an expected 60-day timeline.
The appeal option carries an expected 60-day timeline according to the company's assessment of recent interactions with FDA review staff.
Yes, HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024.
The technology enables physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities, potentially redefining the future of cardiac health management.
Readers can view the full press release at https://ibn.fm/C381i and find the latest news and updates relating to BEAT in the company's newsroom at https://ibn.fm/BEAT.
HeartBeam holds over 20 issued patents related to technology enablement for its 3D ECG platform.
HeartBeam will continue providing updates on commercialization and funding plans as regulatory engagement progresses with the FDA.
Curated from NewMediaWire
