HeartSciences Receives FDA Confirmation for 510(k) Clearance Pathway
HeartSciences Inc. (HSCS)
Company Research
Source: GlobeNewswire
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 aro
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HSCS
News
- HeartSciences (NASDAQ:HSCS) had its price target raised by analysts at Ascendiant Capital Markets from $9.00 to $9.20. They now have a "buy" rating on the stock.MarketBeat
- Heart Test Laboratories reports Q2 results [Seeking Alpha]Seeking Alpha
- HeartSciences Reports Fiscal Second Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswire
- HeartSciences Announces FDA 510(k) Submission for MyoVista® wavECG™ DeviceGlobeNewswire
- HeartSciences Announces Major Upgrade to User Features of MyoVista Insights Platform with Commercial Launch Version 1.1 [Yahoo! Finance]Yahoo! Finance
HSCS
Sec Filings
- 12/22/25 - Form 4
- 12/22/25 - Form 4
- 12/22/25 - Form 4
- HSCS's page on the SEC website