Validated across more than 1,500 patients in multicenter clinical studies.
RCE has generated clinical validation data across more than 1,500 patients to date — peer-reviewed publications, multicenter validation, conference presentations, and late-breaker data spanning multiple cohorts and care settings.
| Study | Cohort | Design |
|---|---|---|
| Communications Medicine, 2022 | Described cohort | Peer-reviewed |
| European Heart Journal – Digital Health, 2023 | 238 ACS patients | Multicenter |
| Clinical & Experimental Emergency Medicine (10-hospital) | 840 enrolled | Observational, multicenter |
| 2025 Multicenter Preprint / Late-Breaker | Expanded cohort | Multicenter validation |
Validated across more than 1,500 patients in multicenter clinical studies.
Peer-reviewed publications in Communications Medicine and European Heart Journal – Digital Health.
Consistent detection performance for high-grade obstruction across 10+ hospital sites and diverse patient populations.
350-patient FDA pivotal study currently in execution across five U.S. sites.
Class II De Novo submission. Novel, non-invasive diagnostic modality without a clean 510(k) predicate. FDA interactions completed; pivotal study in execution across five U.S. sites (350 patients). Submission anticipated 2026.
Pursuing Class II De Novo FDA approval — submission anticipated 2026.
Safety and effectiveness will ultimately be determined by the FDA pivotal study.
Infrasensor is an investigational device. Not yet cleared by the FDA. Pursuing Class II De Novo approval; submission anticipated 2026.