HeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its HeartBeam AIMI platform technology for use in diagnosing heart attacks.
“The 510(k) submission of our first product, based on our platform technology, is an important milestone toward commercialization and underscores our continued progress toward making the HeartBeam AIMI platform widely available to help Emergency Department physicians correctly and expeditiously diagnose patients with chest pain or other symptoms of a heart attack,” said Branislav Vajdic, PhD, HeartBeam CEO and founder. “I am proud of the HeartBeam team for their commitment to achieving this critical step in bringing the Company’s technology to market. We look forward to working through the FDA review process toward our goal of clearance for the US market.”
The HeartBeam AIMI platform technology is anticipated to assist health care professionals 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. The goal of HeartBeam’s technology is to offer more accurate heart attack detection to triage patients and expedite treatment.
HeartBeam AIMI is software as a medical device with a 510(K) regulatory pathway. The HeartBeam algorithm used in an emergency department setting slots into existing physician workflow, leverages existing 12-lead ECG hardware and provides the attending physician with an instant comparison of the patient’s baseline and symptomatic ECG for their consideration in the patient’s diagnosis. This will allow physicians to quickly determine if a patient needs intervention or can be discharged which helps manage patient flow.