Stock Taper 
HeartBeam, Inc. develops telemedicine solutions, including a portable ECG device and cloud-based software, for remote detection and monitoring of cardiac disease to aid physicians in cardiovascular patient care.
HeartBeam AIMIGo is a credit card-sized ECG device with a smartphone app, enabling remote, real-time heart attack detection and arrhythmia assessment, recently FDA-cleared for arrhythmia and under review for heart attack diagnosis.
HeartBeam, Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative 12-lead electrocardiogram (ECG) synthesis software. This pivotal regulatory approval for their credit-card sized, cable-free device, designed for at-home arrhythmia assessment, followed a successful appeal of a prior 'Not Substantially Equivalent' (NSE) determination, marking a major turning point for the company and its commercialization strategy.
After successfully appealing an earlier 'Not Substantially Equivalent' (NSE) decision from the FDA, HeartBeam secured 510(k) clearance for its core product, a credit-card sized device that synthesizes a 12-lead ECG. This regulatory green light is the company's most significant 2025 milestone, fundamentally shifting it from a development-stage to a commercial-stage entity and unlocking its entire go-to-market strategy.
Medical technology provider HeartBeam, Inc. (NASDAQ:BEAT) received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its at-home cardiac assessment tool.
SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam Receives FDA Breakthrough Device Designation for Heart Attack Assessment.
HeartBeam, Inc. (NASDAQ: BEAT - Get Free Report) has been given an average rating of "Moderate Buy" by the nine research firms that are presently covering the company, MarketBeat Ratings reports. One equities research analyst has rated the stock with a sell rating, three have assigned a hold rating, four have issued a buy rating and
Overall rating: C-
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