HeartBeam (Nasdaq:BEAT) announced today that it submitted a 510(k) clearance application to the FDA for its HeartBeam AIMI platform.
Santa Clara, California-based HeartBeam designed its proprietary electrocardiogram (ECG) technology for use in diagnosing heart attacks.
The company’s HeartBeam AIMI platform assists healthcare professionals in identifying patients who present with chest pain to facilitate rapid detection of a heart attack and determine an appropriate treatment regimen. According to a news release, the goal is to offer more accurate heart attack detection to triage patients and expedite treatment.
“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, 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.”
HeartBeam AIMI will follow the 510(k) pathway as software as a medical device. The algorithm used in an emergency department setting slots into existing physician workflows, leverages existing 12-lead ECG hardware and provides the attending physician with an instant comparison of the patient’s baseline and symptomatic ECG for consideration in the diagnosis process, allowing for quick determination of the need for intervention or discharge to help manage patient flow.
The company anticipates that, because the approval process does not require human or animal trials, it will receive clearance by the end of 2022 with a limited market release at that time and a full commercial earmarked for the first quarter of 2023.
“While the FDA conducts its regulatory review, our team will focus on executing key components of its commercialization plan and subscription revenue model,” EVP and Chief Business Officer Jon Hunt said. “We continue to engage in positive discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize our products. We look forward to approval and offering our HeartBeam AIMI platform in an expected $500 million total addressable market.”