Niramai bags US FDA clearance for their medical device, SMILE-100 System

Bengaluru: Niramai Health Analytix, the deep-tech Bangalore-based healthcare company offering a novel radiation-free, non-touch, accurate, breast cancer screening solution in India, 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 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.

The SMILE-100 System assists experts to visualize 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 of 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.”

Niramai is a pioneer in breast cancer screening with 26 granted international patents. An US FDA approved device is a marquee asset for any Indian health-tech company. In fact, Niramai is the first Indian company to get an US FDA clearance for a medical device used for women’s health. Last year, the company announced European CE approval for their Thermalytix™ Solution and have already started pilots in multiple European countries. This FDA approval will now give Niramai a tool to foray into the US market and beyond.

Dr. Kiran Mazumdar Shaw, the global biotech business leader and Biocon chairperson 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”.

Manish Singhal, Founding Partner of pi Ventures and the lead investor of Niramai who has been part of their journey since 2017, commented, “In the last five years, we have seen Niramai grow in every aspect – product innovation, team strength, clinical provenance, product adoption and international recognition. I congratulate the team for this exciting win of the FDA clearance for their SMILE-100 System. It’s a great feat for any Indian Startup to get US approval for their medical device. This can be the key inflection point for the company to take their product truly global, saving lives all over the world.”