HeartBeam Outlines Comprehensive Regulatory Strategy Following FDA’s Not Substantially Equivalent Determination for 12-Lead ECG Synthesis Software
HeartBeam, Inc., a medical technology company pioneering innovative cardiac diagnostic solutions, has provided a detailed update on its regulatory pathway after receiving a Not Substantially Equivalent (NSE) determination from the U.S. Food and Drug Administration (FDA) regarding its 510(k) submission for the company’s 12-lead Electrocardiogram (ECG) Synthesis Software. The company, which is focused on transforming cardiac care through advanced digital technologies and personalized cardiac insights, emphasized its commitment to navigating this regulatory step in a strategic and collaborative manner.
The NSE determination, while not the outcome the company initially sought, represents a common part of the regulatory process for novel technologies. HeartBeam underscored that such decisions do not reflect negatively on the clinical utility of a product but instead signal that the FDA requires additional clarity, data, or labeling modifications before granting clearance. Upon receiving the NSE letter, HeartBeam immediately initiated discussions with FDA review staff to gain a detailed understanding of the agency’s concerns and to identify pathways that would most effectively lead to a successful resolution.
Active Engagement With the FDA
According to the company, communication with the FDA was initiated immediately after the NSE notification and has remained ongoing and constructive. HeartBeam noted that the agency has shown clear willingness to work collaboratively to resolve the outstanding issues in a timely manner. This openness, combined with the company’s own confidence in its scientific and clinical dossier, forms the basis of a multipronged strategy designed to advance toward clearance.
Central to the company’s confidence is its clinical study, VALID-ECG, which was submitted as the primary clinical evidence supporting the 510(k) application. HeartBeam reiterated that the study achieved its primary clinical endpoints and demonstrated strong performance characteristics for the 12-lead ECG Synthesis Software. The company continues to stand firmly behind the robustness of the study design, methods, and results.
While the FDA acknowledged the strengths of the data, certain concerns remain—concerns that HeartBeam believes can be effectively addressed. Based on discussions with the agency, the company believes these issues largely relate to the proposed labeling of the device rather than the underlying technology or clinical performance. Consequently, revisions to labeling and clarifications regarding clinical use may be sufficient to overcome key regulatory hurdles.
A Parallel Path Strategy to Achieve Clearance
HeartBeam’s leadership emphasized that given the nature of the NSE determination and the FDA’s feedback, the company has opted to pursue several parallel regulatory strategies—an approach commonly used for innovative technologies that encounter unexpected questions during review.
These parallel paths include, but are not limited to:
- Pursuing an appeal of the FDA’s NSE decision
- Submitting an updated or modified 510(k) application
- Implementing labeling changes to address the FDA’s remaining concerns
- Continuing direct dialogue with the FDA’s review team to refine and strengthen the regulatory package
At present, based on the most recent discussions with the FDA, HeartBeam believes that an appeal pathway may present a viable and potentially efficient route toward regulatory resolution. The formal FDA appeal process typically takes approximately 60 days from the submission of appeal documentation to a decision. This timeline provides a structured framework for the company to present the strength of its clinical evidence, address technical questions, and discuss labeling considerations.
HeartBeam emphasized that the availability of multiple options provides flexibility to select the most efficient path as discussions with the FDA evolve. The company intends to remain agile, adjusting its regulatory approach as necessary to achieve a constructive outcome that supports both patient safety and technological innovation.
Commitment to Transparent Communication With Stakeholders
Throughout this process, HeartBeam has reiterated its commitment to keeping shareholders and stakeholders informed about key developments. While regulatory actions move forward, the company will also continue to advance its commercial launch planning and funding strategies. Maintaining transparency regarding timelines, goals, and milestones remains a high priority for the leadership team.
CEO Perspective: Confidence and Collaboration
Robert Eno, Chief Executive Officer of HeartBeam, shared his perspective on the regulatory process and the company’s forward strategy. He highlighted the extensive and positive interactions that HeartBeam has had with the FDA over the past two years as the company worked through complex scientific and regulatory questions related to the novel 12-lead ECG Synthesis Software.
“HeartBeam appreciates the extensive interactions with the FDA on the HeartBeam 12-lead Synthesis Software,” Eno said. “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.”
According to Eno, only a limited and well-defined set of concerns remain, and the company is confident in its ability to address them. He emphasized that these issues do not relate to the core functionality or underlying performance of the ECG synthesis technology, but rather to documentation, labeling clarity, and ensuring that the clinical use-cases are presented in a manner fully aligned with regulatory expectations.
“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,” Eno continued. “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.”
HeartBeam’s update underscores its continued confidence in the clinical value of its 12-lead ECG Synthesis Software and the company’s broader mission to bring advanced cardiac diagnostic capabilities to patients in need. While the regulatory journey has taken an unexpected turn, the company remains optimistic and strategic in navigating the next steps.
With strong clinical data, constructive dialogue with the FDA, and multiple viable routes to clearance, HeartBeam is positioning itself to move forward in the most efficient and effective way possible. The company will continue to prioritize patient impact, scientific integrity, regulatory compliance, and stakeholder communication as it works toward a positive resolution.
Source link:https://www.businesswire.com/
