HeartBeam (Nasdaq:BEAT) has announced the approval of its comprehensive arrhythmia assessment system by the FDA, under 510(k) clearance. The innovative device, developed by the Santa Clara, California-based company, is the first of its kind to earn such approval. This advanced electrocardiogram (ECG) system is compact enough to fit in a credit card-sized form and designed to be cable-free. It provides important heart health information by recording signals from three separate directions.
When symptoms arise, the accompanying app guides users through positioning the device on their chest for a 30-second recording. Once captured, the data is sent to the cloud for processing and transmitted to a physician for evaluation. The medical professional can then analyze the ECG and determine the necessary course of action.
HeartBeam intends to launch an early access program featuring a priority waitlist for patients and physicians eager to use the device. In anticipation of this approval and subsequent commercial rollout, the company appointed a new CEO in October to facilitate growth.
Future developments for HeartBeam may include the development of synthesized 12-lead ECGs, AI-driven classification algorithms, and heart attack detection capabilities.
“There’s substantial evidence that patients who delay care for cardiac symptoms experience poorer clinical outcomes. Allowing them to capture high-fidelity ECG readings from multiple directions, wherever they may be when symptoms present, facilitates timely and necessary care,” stated Robert Eno, CEO of HeartBeam. “Earning FDA clearance for our technology is a major milestone, advancing us closer to our goal of providing unparalleled cardiac insights to individuals and healthcare providers.”