MyoVista wavECG vs Zio

iRhythm holds 18 FDA clearances, the latest a ZEUS Platform clearance on May 29, 2026, and the FY2025 10-K says FDA issues remain open and that a further warning letter, consent decree or recall is possible. Separately, a warning letter of May 25, 2023 said Zio AT was changed without clearance. The vendor describes its Zio algorithm as the first FDA-cleared deep-learned algorithm verified by qualified cardiac technicians.

HeartSciences holds one clearance, the wavECG on October 5, 2026, and it includes no AI-ECG algorithm. The company says it does not intend to commercialize the device without a cleared algorithm, and it names no customers. A business combination with Fortitude Mining Holdings is expected to close in the fourth quarter of 2026, with its effect on the medical business unknown. For a cardiology group signing a multi-year agreement, the funding on record is about $6.375 million gross from the June 2022 IPO and about $23.7 million raised in total per CB Insights, a third-party source.

For a cardiology group that wants an AI-read resting 12-lead ECG this year, HeartSciences loses. A group that wants multi-day outpatient rhythm recordings orders Zio.