FDA applicant

HeartSciences, Inc.

Southlake, TX1 decision2026–20260 recalls

FDA records 1 decision for HeartSciences, Inc. (Southlake, TX) in 2026: 1 510(k) clearance. All are in product code DPS (Electrocardiograph). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided HeartSciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — HeartSciences, Inc. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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HeartSciences, Inc.

Which product codes does it file in?

What has FDA decided for it lately?