- HeartBeam ( NASDAQ: BEAT ) on Tuesday said it was seeking a U.S. FDA approval for its platform technology used in detecting and diagnosing heart attacks.
- The company submitted a so-called 510(k) application to FDA for the HeartBeam AIMI platform technology.
- The HeartBeam technology assists physicians and healthcare professionals to test patients with chest pain to see whether it is being caused due to a heart attack.
- "Our FDA approval process doesn’t require any human or animal trials, so there is good reason to believe that we will receive FDA clearance for a limited market release by end of 2022 and full commercial roll-out in Q1 2023," BEAT executive VP and chief business officer Jon Hunt said in a statement .
- BEAT stock +1.9% to $1.58 in premarket trading.
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HeartBeam seeks FDA approval of its platform technology to detect heart attacks