HeartBeam updates regulatory strategy for 12-lead ECG Synthesis Software

HeartBeam (BEAT) announced its regulatory strategy following receipt of a Not Substantially Equivalent, or NSE, decision on the company’s 510(k) submission for its 12-lead Electrocardiogram Synthesis Software. Immediately following the receipt of the NSE letter, HeartBeam has been engaging with the 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 resolution. The company said it stands behind the clinical study submitted in support of the application. The study met its clinical endpoints and the company believes it has a viable argument to address outstanding concerns of the agency. The company believes these concerns can be addressed through modifications to the proposed labeling of the device. HeartBeam has determined to pursue multiple parallel paths. The range of options include, but are not limited to, an appeal process or a resubmission of a 510(k) application. Based on the recent discussions with the FDA and the information available at present, the company believes there is a path forward under an appeal process. The official appeal process has a timeline of approximately 60 days from submission of an appeal to resolution. “HeartBeam appreciates the extensive interactions with the FDA on the HeartBeam 12-lead Synthesis Software,” said Robert Eno, CEO of HeartBeam. “We have engaged in good faith with the agency over a period of two years and have had extremely positive interactions. Together with the agency, we resolved the vast majority of open questions. After assessing our options, we believe that the best way to resolve the open questions and to get this technology into the hands of patients is to engage in the multiple paths available for constructive resolution. Since the remaining concerns from the FDA are well defined and can be readily addressed by our team, we believe these paths can lead to a favorable resolution.”