Deep-tech startup Niramai becomes the first Indian company to get FDA approval for a medical device in women’s health

On 14 March, Niramai Health Analytix, the Bangalore-based deep-tech healthcare company, received US FDA clearance for their first device called SMILE-100 System. It is the first Indian company to get a US FDA clearance for a medical device used for women's health. 

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

“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 Geetha Manjunath, CEO and Founder of Niramai, said, “

NIRAMAI Health Analytix’s flagship product is Thermalytix, a radiation-free, non-touch, accurate, breast cancer screening test for women of all age groups. NIRAMAI was co-founded in July 2016 by Dr Geetha Manjunath and Nidhi Mathur. 

Niramai is a pioneer in breast cancer screening with 26 granted international patents. Last year, the company announced European CE approval for their Thermalytix™ Solution and have already started pilots in multiple European countries. Niramai provides breast screening services across 19 cities in India.NIRAMAI has so far raised a total of USD 7 mn from institutional investors from India, Japan and Singapore. Investors include Dream Incubator, BeeNext, pi Ventures, Ankur Capital, Axilor Ventures, 500 Startups, and others.