---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-081410"
form_type: "8-K"
ticker: "HSCS"
cik: "0001468492"
company_name: "HeartSciences Inc."
filed_at: "2025-06-04T23:59:59+00:00"
generated_at: "2026-05-19T23:48:16.107285+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# HeartSciences gets FDA Breakthrough Device designation for AI-ECG algorithm detecting aortic stenosis

## Summary
- FDA granted Breakthrough Device designation for HeartSciences' Aortic Stenosis AI-ECG algorithm.
- Algorithm detects moderate-to-severe aortic stenosis via MyoVista Insights cloud platform integrated with EHR.
- Trained on >120,000 ECG records; can detect AS up to 24 months before echocardiography.
- No additional hardware required; uses existing ECG data for real-time or retrospective analysis.

## SEC filing metadata
- accession: 0000950170-25-081410
- form_type: 8-K
- ticker: HSCS
- cik: 0001468492
- company_name: HeartSciences Inc.
- filed_at: 2025-06-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1468492/000095017025081410/0000950170-25-081410-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1468492/000095017025081410/hscs-20250604.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-081410
- JSON: https://secwatch.observer/filing/0000950170-25-081410.json
- Plain text: https://secwatch.observer/filing/0000950170-25-081410.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.