HeartSciences Receives FDA Confirmation for 510(k) Clearance Pathway

Southlake, TX — Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that it has received confirmation from the FDA to change the clearance pathway for its MyoVista wavECG™ device and associated AI-ECG algorithm to a more standard 510(k) submission from the more complex De Novo process.

"The new FDA product classification for AI-ECG paves the way for a more structured and faster 510(k) process for our MyoVista device, as well as our industry leading library of AI-ECG algorithms. We also intend to deliver these algorithms using a cloud-based, hardware agnostic platform that will provide innovative AI-ECG diagnosis from millions of existing ECG devices around the world, in addition to our MyoVista device," said Andrew Simpson, CEO of HeartSciences. "The switch to 510(k) will require some changes, but we believe it will result in faster clearance overall. In November, the core lab finished their work on our MyoVista pivotal study following the conclusion of patient recruitment announced earlier in 2023. We remain on track for submission of the MyoVista to the FDA in the first half of 2024 and a targeted clearance during 2024."