At a glance
- Company
- HeartBeam, Inc.
- Ticker
- NASDAQ: BEAT
- Announcement
- Regulatory
Key figures
- Expected appeal timeline
- 60-day
- ECG leads synthesized
- 12-lead
- Issued patents
- over 20
- FDA clearance for arrhythmia assessment
- December 2024
Products and programs
HeartBeam (NASDAQ: BEAT), a medical technology company developing personalized cardiac-care insights, detailed its strategy following receipt of a Not Substantially Equivalent decision for its 510(k) submission covering its 12-lead ECG Synthesis Software. The Company has been in active discussions with FDA review staff, which have signaled willingness to work toward a constructive resolution. HeartBeam said its VALID-ECG clinical study met endpoints and that remaining FDA concerns may be resolved through revised labeling. To advance the process, the Company plans to pursue multiple parallel paths—including a formal appeal or a 510(k) resubmission—and believes recent interactions indicate a viable path forward under the appeal option, which carries an expected 60-day timeline. HeartBeam will continue providing updates on commercialization and funding plans as regulatory engagement progresses.
To view the full press release, visit https://ibn.fm/C381i
About HeartBeam, Inc.
HeartBeam, Inc. is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company 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. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. The Company holds over 20 issued patents related to technology enablement.
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The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT
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In brief
HeartBeam says it is considering parallel regulatory options after receiving a Not Substantially Equivalent decision on its 510(k) submission for 12-lead ECG Synthesis Software. The company reports that discussions with FDA review staff are ongoing and that the staff have indicated openness to working toward a resolution. HeartBeam says its VALID-ECG study met its endpoints and that revised labeling could address outstanding FDA concerns. The company plans to pursue a formal appeal or submit a new 510(k), and says recent interactions suggest an appeal could offer a viable route, with an expected 60-day timeline. HeartBeam also says it will provide updates on commercialization and funding plans as its regulatory engagement continues. Its background information notes prior FDA clearance for arrhythmia assessment and more than 20 issued patents.
Key takeaways
- HeartBeam received a Not Substantially Equivalent decision for its 510(k) submission covering ECG Synthesis Software.
- The company says its VALID-ECG study met endpoints and revised labeling may address remaining FDA concerns.
- HeartBeam plans to pursue a formal appeal or a 510(k) resubmission.
- The company cites an expected 60-day timeline for the appeal option.
