Niramai SMILE-100 System: FDA-Cleared Thermal Imaging for Breast Health
The SMILE-100 System (also called BreastHealth-100) is a medical device developed by Niramai. It is an US FDA cleared test that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It can be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel. It is intended for use as adjunctive diagnostic imaging for thermally significant indications in the breast region.
For more information:
- Niramai gets US FDA clearance for their first medical device, SMILE-100 System
- US FDA 510k Summary for SMILE-100
This picture gives you the differences between SMILE-100 and Thermalytix. Please note that the SMILE-100 System includes only a subset of functionality of Thermalytix. In particular, it does not include the AI-based scoring and Vascularity analysis that Thermalytix has.