MIMOSA Imager
MIMOSA Diagnostics IncThe 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.
Intended Use
The MIMOSA Imager is intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue, for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is suspicion of compromised circulation in medical environments including physician offices, hospitals, ambulatory care, and Emergency Medical Services.
Technology
The device is a non-contact, cordless, battery powered tissue oximeter. It captures spatially-resolved images triggered via a smartphone app, detecting spectral signatures using both visible (VIS) and near-infrared (NIR) LED wavelengths. The remitted light is used to calculate StO2 based on multispectral imaging principles, providing a heat-map of tissue oxygen saturation spatially registered to the tissue.
Performance
The device underwent non-clinical testing including LED system spectral response, transmittance profile, and stress testing for endurance and consistency. Software validation followed FDA guidance for medical device software. Clinical testing compared MIMOSA Imager with a predicate ViOptix ODISsey device in a vascular occlusion test with 39 subjects, showing high statistical agreement in StO2 measurements and no adverse events, demonstrating substantial equivalence and acceptable accuracy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/14/2019
8 months - 2
FDA Approval
11/1/2019
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