FDA Radiology AI Devices

The Cerebral Autoregulation Index (CAI) Algorithm is a software tool designed to help clinicians monitor whether cerebral autoregulation—the brain's ability to maintain stable blood flow—is intact or impaired. It analyzes signals from cerebral oximetry and blood pressure monitors to provide an index value indicating the level of coherence between these parameters. This helps guide advanced hemodynamic monitoring in critical care patients without making direct therapeutic decisions.

The MIMOSA Imager is a cordless, non-contact tissue oximeter that estimates and maps oxygen saturation in superficial tissue. It captures spatially-resolved images using visible and near-infrared light and presents tissue oxygenation as a heat map on a connected Android device. This helps clinicians monitor circulatory or perfusion status in patients, especially for skeletal muscle and suspected compromised circulation.