HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application
Heartbeam, Inc. (BEAT)
Last heartbeam, inc. earnings: 2/26 04:05 pm
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Source: Business Wire
Company engaging in multiple options for a constructive resolutionStrategy is underpinned by a clinical study that achieved the agreed upon endpointsCompany believes that labeling modifications can address any outstanding concerns SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced its regulatory strategy following receipt of a Not Substantially Equivalent (NSE) decision on the Company’s 510(k) submission for its 12-lead Electrocardiogram (ECG) Synthesis Software.Immediately following the receipt of the NSE letter and through today, HeartBeam has been engaging with the Food and Drug Administration (FDA) review staff to better understand the concerns and determine the best path forward.The FDA has signaled a willingness to work with the Company towards a constructive resolution.The Company stands behind the clinical study (VALID-ECG) submit
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- Earnings To Watch: HeartBeam Inc (BEAT) Reports Q3 2025 Results [Yahoo! Finance]Yahoo! Finance
- HeartBeam to Host Third Quarter 2025 Results Conference Call on Thursday, November 13, 2025 at 4:30 p.m. Eastern TimeBusiness Wire
- HeartBeam Teams Up With HeartNexus to Deliver Cardiologist-Level ECG Insights Anytime, AnywhereBusiness Wire
- HeartBeam (BEAT) Combining Portability and Precision to Redefine Future of Cardiac Care [Yahoo! Finance]Yahoo! Finance
BEAT
Earnings
- 11/13/25 - Beat
BEAT
Sec Filings
- 11/21/25 - Form 8-K
- 10/3/25 - Form 4
- 10/3/25 - Form 4
- BEAT's page on the SEC website