MIMOSA Imager

The MIMOSA Imager is a non-contact device that estimates and spatially maps tissue oxygen saturation (StO2) using multispectral imaging principles, illuminating tissue with specific visible and near-infrared LED wavelengths to analyze chromophore spectral signatures. Its clinical utility in monitoring circulatory or perfusion status in skeletal muscle has been demonstrated through comparative studies showing statistical agreement with predicate oximetry technology, facilitated by a smartphone interface for control and display.

The MIMOSA Imager is a non-contacting, cordless, battery-powered device designed for non-invasively estimating the spatial distribution of percent oxygen saturation (StO2) in tissue. It operates by exposing superficial tissue to light from both visible (VIS) and near-infrared (NIR) LEDs, specifically at 620, 630, 700, 810, 880, and 980 nm wavelengths. The device captures the remitted or reflected light, and through multispectral imaging principles and spectral analysis of dominant chromophores, it calculates StO2. Controlled via a smartphone application that also displays the StO2 estimate as a spatially registered heat-map, the MIMOSA Imager is intended for use by healthcare professionals in physician offices, hospitals, ambulatory care, and Emergency Medical Services for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when compromised circulation is suspected. Performance validation of the MIMOSA Imager included non-clinical testing to ensure its LED system met tolerances for illumination wavelength ranges, relative intensity differences, and endurance, alongside software documentation and testing. A clinical comparative study was conducted against the ViOptix ODISsey predicate device, involving 39 individuals aged 21 to 70 with Fitzpatrick skin types 1-5. This study utilized a vascular occlusion test (VOT) on the thenar eminence and forearm, demonstrating statistical agreement in StO2 measurements between the MIMOSA Imager and the predicate device, with the 95% confidence interval for the slope of the best-fit line between 0.998 and 1.02. No adverse events or complications were reported during or after the clinical testing, supporting the device's safety and effectiveness.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the MIMOSA Imager's use of six specific LED wavelengths (620, 630, 700, 810, 880, 980 nm) improve StO2 measurement reliability and dataset robustness compared to devices using fewer or different wavelengths, such as the predicate's 690nm and 830nm laser diodes?; What is the validated range of distances and angles for the non-contact measurement, and how does the device ensure consistent accuracy if these parameters vary during clinical use?; Beyond the tested Fitzpatrick skin types 1-5, how does the device's accuracy perform on higher Fitzpatrick skin types or in the presence of conditions like significant edema, tattoos, or scarring in the measurement area?; How does the spatial resolution of the StO2 heat-map generated by the MIMOSA Imager aid in differentiating various types of circulatory compromise or in monitoring the precise boundaries of ischemic tissue?; What are the specific chromophores tracked by the device, and how does the algorithm differentiate their spectral signatures to calculate StO2, especially in tissues with complex optical properties?