HeartBeam receives FDA NSE letter for ECG software, evaluates 3D ECG system launch

HeartBeam, Inc. (NASDAQ:BEAT) announced Thursday that it received a Not Substantially Equivalent (NSE) letter from the U.S. Food and Drug Administration regarding its 510(k) application for its 12-Lead Electrocardiogram (ECG) Synthesis Software. The company stated that it will work with the FDA to resolve the matter and stands behind its clinical data. With a market capitalization of just $57.87 million and a current stock price of $1.54, the micro-cap medical technology firm has seen its shares decline nearly 27% year-to-date, according to InvestingPro data.

In addition, HeartBeam is evaluating the launch of its 3D ECG system, which previously received FDA 510(k) clearance in December 2024. InvestingPro analysis indicates HeartBeam is currently undervalued despite regulatory challenges. The company’s financial health score is rated as "WEAK," with a current ratio of 0.86 suggesting short-term obligations exceed liquid assets. Analyst price targets range widely from $1 to $8, reflecting significant uncertainty about the company’s prospects.

This information is based on a press release statement included in a recent SEC filing. For investors seeking deeper insights into HeartBeam’s financial condition and growth prospects, InvestingPro offers additional ProTips and comprehensive analysis through its Pro Research Report, transforming complex financial data into actionable intelligence for more informed investment decisions.

In other recent news, HeartBeam Inc. reported its financial results for the third quarter of 2025, revealing a net loss of $5.3 million. The company’s earnings per share (EPS) came in at -$0.15, which did not meet analysts’ expectations of -$0.08. This earnings miss has raised concerns among investors regarding HeartBeam’s financial performance. The release of these results has been a significant development for the company. Additionally, the reaction from the market reflects the unease about the company’s future prospects. These recent updates are pivotal for stakeholders and potential investors to consider.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.