FDA pivotal study · in execution

Three minutes to identify what hours of observation may miss.

A wrist-worn, AI-enabled diagnostic platform. Non-invasive.
Results in three minutes.
Designed for the emergency department.

Time to insight
~3min
at the point of care
Patients studied
1,500+
multicenter clinical studies
Pivotal study
350
patients · 5 U.S. sites
01The time problem

A patient arrives with chest pain. The ECG is non-diagnostic. The first troponin draw is ordered. Then the wait begins — 1 hour, 3 hours, sometimes 6 or more — before serial results confirm or exclude high-grade obstruction. During that window, if a severe coronary occlusion is present, heart muscle is dying.

Infrasensor was designed for that window. It delivers an identification result at the moment the patient arrives — not hours later, when the answer finally emerges from the serial protocol.

Read more about the problem
02The platform
Infrasensor platform, bedside unit with handheld sensor.

Infrasensor is a wrist-worn, AI-enabled diagnostic platform designed to identify severe coronary occlusion in approximately three minutes — non-invasively, at the point of care, as an adjunct to standard of care in the emergency department.

03Scientific validation
Validation

Validated across more than 1,500 patients in multicenter clinical studies.

Peer review

Peer-reviewed publications in Communications Medicine and European Heart Journal – Digital Health.

Pivotal study

350-patient FDA pivotal study currently in execution across five U.S. sites.


RCE is backed by
American Heart AssociationCedars-Sinai AcceleratorTexas Medical CenterNational Science FoundationAmerican College of Cardiology
04Who it's for

For clinicians

Infrasensor integrates into the earliest moments of the ED encounter.

For health systems

For high-volume emergency departments, the cost of the current ACS observation pathway is measured in boarding hours, bed-days, and throughput drag.

05Regulatory status

Pursuing Class II De Novo FDA approval — submission anticipated 2026.

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