HeartBeam Submits 510(k) Application To FDA For AIMI Platform Technology To Diagnose Heart Attacks

Digital healthcare company HeartBeam, Inc. (BEAT) announced Tuesday it 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 HeartBeam AIMI platform technology is anticipated to assist health care professionals in 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.

HeartBeam said as the FDA approval process does not require any human or animal trials, it expects to receive FDA clearance for a limited market release by end of 2022 and full commercial roll-out in the first quarter of 2023. HeartBeam AIMI platform has an expected $500 million total addressable market.

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