Zio vs OpenEvidence

FDA sent iRhythm a warning letter on May 25, 2023 over a Zio AT change made without clearance and marketed to a new high-risk population, and a Form 483 followed inspections in July 2024. Two Zio AT 510(k)s cleared in October 2024, iRhythm holds 18 clearances in all, and the FY2025 10-K still says FDA issues remain open and that another warning letter, a consent decree or a recall is possible. Zio AT adds mobile cardiac telemetry to technician-validated reports, which fits a cardiology group. A hospital that treats an open FDA compliance issue as disqualifying will rule it out.

OpenEvidence is a free literature tool for verified US physicians, paid for by advertising. It states HIPAA compliance under a standard Business Associate Agreement and SOC 2 Type II for the Security category. A r/emergencymedicine user reported an inaccuracy on chest x-ray and pulmonary embolism on September 30, 2025, while a r/FamilyMedicine thread on January 13, 2026 was titled "My favorite OpenEvidence feature". Access is closed to anyone who is not a verified US clinician.