Heartbeam Inc's stock fell by 14.22%, crossing down the 5-day SMA as the company adjusts its regulatory strategy following the FDA's Not Substantially Equivalent (NSE) decision.
The NSE decision has prompted Heartbeam to engage with FDA staff to clarify concerns and explore multiple paths, including an appeal or resubmission of its 510(k) application. The company believes its VALID-ECG clinical study met its endpoints, which could help address the FDA's concerns.
Despite the recent drop, Heartbeam's stock had previously surged over 40% in after-hours trading following the announcement of its regulatory strategy, reflecting investor optimism. However, the overall market sentiment remains cautious, with the Nasdaq-100 down 0.93% and S&P 500 down 0.58%.
Wall Street analysts forecast BEAT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BEAT is 5.83 USD with a low forecast of 4.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
Wall Street analysts forecast BEAT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BEAT is 5.83 USD with a low forecast of 4.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 1.640
Low
4.00
Averages
5.83
High
8.00
Current: 1.640
Low
4.00
Averages
5.83
High
8.00
Roth Capital
NULL -> Buy
initiated
$4
2025-10-31
Reason
Roth Capital
Price Target
$4
AI Analysis
2025-10-31
initiated
NULL -> Buy
Reason
Roth Capital initiated coverage of HeartBeam with a Buy rating and $4 price target. The company is developing a credit-card-sized, cable-free cardiac device that synthesizes a 12-lead electrocardiogram, the analyst tells investors in a research note. The firm expects FDA clearance in the "coming days" that will initially focus on advanced cardiac arrhythmias within the concierge medicine market.
About BEAT
HeartBeam, Inc. is a cardiac technology company. The Company focuses on developing and commercializing higher resolution ambulatory Electrocardiogram (ECG) solutions that enable the detection and monitoring of cardiac disease both inside and outside a healthcare facility setting. It is engaged in the development of higher resolution ECG solutions is achieved through the development of the Company’s proprietary and patented electrocardiography technology platform. It is developing three-dimensional (3D) representations of cardiac electrical activity by displaying the spatial locations of ECG waveforms. It is developing its own product, the HeartBeam System. The HeartBeam System comprises a credit card sized 12-lead output electrocardiogram device, a patient application, a physician portal, and powerful cloud-based algorithms. The core technology consists of a series of patented inventions that allow it to capture the heart’s electrical activity from three distinct directions.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
