Common Stock
- Symbol
- HSCS
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
HeartSciences Inc.
HSCSNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 9.01 Financial Statements and Exhibits (a) Exhibits Exhibit Description Number ─────────────────────────────────────────────────────────── 99.1* Press Release, dated October 6, 2026. 104* Cover Page Interactive Data File (embedded within the Inline XBRL document). Furnished herewith.
Press release in this filing
HeartSciences Receives FDA 510(k) Clearance for its MyoVista® wavECGTM Device →Company context
HeartSciences is a healthcare information technology company advancing the use of ECG/EKGs through the integration of artificial intelligence. HeartSciences’ MyoVista Insights™ Platform is a cloud-native, vendor- and device-agnostic ECG management system designed to modernize ECG workflows and improve clinical efficiency and decision-making. The platform’s AI-ECG marketplace is designed to deliver AI-ECG algorithms into clinical workflows across a health system’s existing ECG equipment.
Current securities
Registered securities in this filing
HEARTSCIENCES INC. · 8-K · Filed 2026-10-06
Warrants
- Symbol
- HSCSW
- Exchange
- NASDAQ
- Classification
- WARRANT
- Status
- Current
Disclosure sections
Item 9.01Item 9.01 - Financial Statements and Exhibits
Item
9.01 Financial Statements and Exhibits
(a)
Exhibits
Exhibit Description
Number
───────────────────────────────────────────────────────────
99.1* Press Release, dated October 6, 2026.
104* Cover Page Interactive Data File (embedded
within the Inline XBRL document).
Furnished
herewith.
Filed exhibits (1)
Exhibit 99.1 HeartSciences Receives FDA 510(k) Clearance for its MyoVista ® wav ECG TM Device Southlake, TX, October 6, 2026 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today announced that the U.S. Food and Drug Administration (“FDA”) has granted 510(k) clearance (K260005) for its MyoVista® wavECGTM device as a 12-lead resting electrocardiograph. The clearance covers the acquisition and interpretation of ECG signals from adult and pediatric patients in hospitals and healthcare facilities, with interpretive statements provided to clinicians on an advisory basis. The clearance does not include an AI-ECG algorithm. As previously reported, HeartSciences separated the FDA submissions for the MyoVista wavECG device and its impaired cardiac relaxation AI-ECG algorithm following updated guidance published by the American Society of Echocardiography regarding the assessment of left ventricular diastolic dysfunction. The Company does not intend to commercialize the devi…
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