Cardiology
EchoNext
Pathwai, Inc.
Software that analyses 12-lead ECG recordings from compatible ECG devices, in parallel to the standard of care, to detect signs associated with structural heart disease in patients aged 18 and older. When such signs are found it may also flag six sub-labels: reduced left ventricular ejection fraction, right ventricular dysfunction, severe left ventricular hypertrophy, aortic stenosis, valvular regurgitation and pulmonary hypertension. It identifies patients for further follow-up, is not for patients with implanted pacemakers, and is not intended to rule out follow-up.
FDA Submission Metadata
- Submission number
- K260332
- Decision date
- June 2026
- FDA panel
- Cardiovascular
- Product code
- QXO
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals