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HeartSciences Receives FDA Confirmation for 510(k) Clearance Pathway
Southlake, TX, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"),
About this update from Heartsciences Inc.
[{"type":"text","content":"Southlake, TX, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) (\"HeartSciences\" or the \"Company\"), 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. Andrew Simpson, Chief Executive Officer of HeartSciences, said, \"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.” Mr. Simpson added, “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.” About HeartSciences Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG's clinical usefulness. Undetected heart disease is one of the biggest challenges in healthcare and millions of ECGs are performed every week. The Company's objective is to improve healthcare by making an ECG a far more valuable cardiac screening tool. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. HeartSciences also has an industry leading library of AI-ECG algorithms, technologies and patent rights developed using millions of ECG records which the Company intend...