The SMILE-100 System is 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.
Niramai gets US FDA clearance for their first medical device, SMILE-100 System