HeartBeam is expanding the available patient population for its emergency department software technology solution. In evaluating the electrocardiogram (ECG) database for the clinical validation of HeartBeam’s platform technology, a significant portion of consecutive patients fell into the category of unstable angina.
In light of the 2021 guidelines from the American Heart Association (AHA), American College of Cardiology (ACC), American Society of Echocardiography (ASE), American College of Chest Physicians (CHEST), Society for Academic Emergency Medicine (SAEM), Society of Cardiovascular Computed Tomography (SCCT), and Society for Cardiovascular Magnetic Resonance (SCMR) for the Evaluation and Diagnosis of Chest Pain and in consultation with its clinical advisors, HeartBeam elected to include the full data set for clinical validation studying in support of the 510(k) submission. The expanded scope of the clinical validation study will provide access to a broader patient population for HeartBeam’s technology once cleared by the US Food and Drug Administration (FDA).
Due to the expanded available patient population, HeartBeam expects to file a 510(k) with the full dataset for clinical validation no later than 15 August 2022 and does not affect the timeline for 510(k) submission of the telehealth product.
“It is important to include unstable angina as a diagnosis for analysis. Patients with unstable angina may have subtle electrical changes brought on by ischemia without definitive injury to the cardiac tissue,” said Russell Jones (Phoebe Putney Health System, Albany, USA). “Given HeartBeam’s advanced technology solution, there is potential to identify patients who cannot be diagnosed by traditional ECG capabilities but may require intervention.”
HeartBeam’s platform is anticipated to assist physicians in identifying patients who present with chest pain to facilitate rapid detection of a heart attack and determine an appropriate treatment regimen. Chest pain is the second most common reason for an emergency department visit, with high costs associated with these visits. HeartBeam’s software solution may offer more accurate heart attack detection to triage patients and expedite treatment. The HeartBeam technology platform has not yet been evaluated by the FDA and is not approved for clinical use in the USA or other global geographies.