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Niramai bags US FDA clearance for SMILE-100 system

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The SMILE-100 System is a breast thermography device that helps healthcare personnel to review, measure and analyse thermally significant indications in the breast region

Niramai Health Analytix has now received US FDA clearance for their first device called SMILE-100 System. The SMILE-100 System is a breast thermography device that helps healthcare personnel to review, measure and analyse 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. 

The SMILE-100 System assists experts to visualise high thermal activity patterns clearly demarcated on thermal images as hotspots and can enable healthcare professionals to make better decisions in breast cancer screening and diagnosis.  Another unique feature of SMILE-100 is use of their patented artificial intelligence-based algorithms to check the quality of input thermal images, which can greatly reduce the errors in thermal image capture and enable low skilled health workers to confidently perform the imaging.

Dr Geetha Manjunath, CEO and Founder, Niramai, said, “We are super excited to announce the FDA 510(k) clearance of SMILE-100 System. A proud moment for the team. It was a great learning experience to go through the very rigorous US regulatory process. This win further validates the intrinsic power of the NIRAMAI team and has given us the confidence that we can build many more such world-class medical devices of high quality and help reduce untimely deaths due to cancer.”

Dr Kiran Mazumdar Shaw, Chairperson, Biocon appreciated this news and said “I congratulate Geetha and her team for this tremendous achievement. Niramai is one of the very few deep-tech startups from India which has obtained both European and US clearance for their innovative medical device. Indian startups are solving important healthcare problems that are the need of the hour today. Such milestones of innovation showcase the power of Indian women-led companies to the rest of the world”.

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