Niramai pioneering women’s health medical device gets US FDA clearance

Cancer is a name that sparks fear in the masses instantly. The World Health Organization (WHO) estimates that 2.3 million women has been diagnosed with breast cancer in 2020, with 685,000 fatalities. Breast cancer is the most common malignancy that affects every woman, it is possible to state. 

Niramai is a Bangalore-based deep-tech healthcare firm, founded by Dr Geetha Manjunath and Nidhi Mathur in July 2016. The firm is working on a breast cancer diagnosis AI technology that uses a unique AI algorithm to analyse breast images captured with a thermal camera to determine the presence or absence of breast cancer with a high detection rate. It is anticipated that it will aid in the early discovery of carcinogenic cells.   

NIRAMAI Health Analytix’s flagship product ,Thermalytix,is a radiation-free, non-touch, accurate breast cancer screening test for women of all ages. They recently gained US FDA approval for their first device, the SMILE-100 System, on March 14th. It is the first Indian business to receive FDA approval for a medical device for women’s health in the United States. This is also the first Indian firm to have medical devices approved by the FDA in the field of women’s health. With 26 approved worldwide patents, Niramai is a pioneer in breast cancer screening.  

“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, quoted.  

Since joining Niramai as a lead investor in Series A in 2019, DI has followed the company’s expansion into the Japanese and US markets, as well as the consideration and implementation of regulatory policies. We feel that obtaining FDA certification will be a significant step forward in the global support of breast cancer medical care, and we will continue to advocate for companionship.  

The company received European CE approval for their ThermalytixTM Solution last year and has already begun pilots in several European countries. Niramai offers breast screening services in 19 Indian cities.