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