Niramai Gets FDA’s 510(k) Clearance for its Smile-100 Breast Thermography System

Bangalore, India-based Niramai Health Analytix has received the FDA’s 510(k) clearance for its Smile-100 System, a thermography device for breast cancer screening.

The device, which does not use radiation, is designed to help healthcare professionals analyze thermally significant indications in the breast region.

The touch-free product is cleared as an adjunctive diagnostic imaging device for use in hospitals, acute care settings, outpatient surgeries and other healthcare facilities, the company said.