Niramai gets USFDA nod for medical device SMILE-100 System

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".

Mr. 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."

NIRAMAI has now created its own reputed brand in India with their innovative breast health products. Partnering with experienced radiologists and reputed hospital/ diagnostic chains in India such as Apollo Clinics, HCG Cancer Hospitals, Rainbow Hospitals among others, Niramai provides breast screening services across 19 cities in India. Niramai also conducts large scale screening camps in association with Karnataka Cancer Society, Rotary International and other socially concerned organizations. With the FDA cleared SMILE-100 System and CE approved Thermalytix™ products, the company is now taking their Made-in-India innovation to global scale.