Healthtech Startup Niramai receives CE Mark Approval to Expand to Europe

By: WE Staff | Wednesday, 7 April 2021

Bengaluru based Niramai, the deep-tech Health Analytix, which offers Artificial Intelligence (AI)-based, radiation-free breast cancer screening test has received the CE Mark approval, ISO 13485, and MDSAP (Medical Device Single Audit Program) International Certifications. This allows the startup to sell the product in any part of the European Economic Area. 

Breast cancer is the most common and leading cancer among women. According to the World Health Organization, one out of every eight women in the U.S. is at risk of developing a breast abnormality during her lifetime. It is well known that early detection is crucial in saving a cancer patient's life.

In 2021, women in the U.S. are predicted to be diagnosed with 2,81,550 new cases of invasive breast cancer and 49,290 new cases of non-invasive (in situ) breast cancer. A 2018 report of Breast Cancer statistics recorded 1,62,468 new cases and 87,090 reported deaths in India. Cancer survival becomes more difficult in higher stages of its growth, and more than 50 percent of Indian women suffer from stage 3 and 4 of breast cancer.

Niramai, founded in 2016, has developed a novel breast cancer screening solution that uses Thermalytix, i.e. machine intelligence over thermography images and cloud hosted analytics solution that uses big data analytics, artificial intelligence, and machine learning algorithms for early & accurate breast cancer screening. Cancer can be detected at a much early stage than traditional diagnostic methods. The method they use can detect tumors that are five times smaller than what a clinical exam can detect.

The solution is already in use across several hospitals and clinics, including HCG Hospital, Apollo Clinics, and Healthspring Diagnostics among others, across the country and now it has received approval to offer its product service abroad.

“We are delighted to receive the CE marking, ISO, and MDSAP certifications for our technology, further strengthening our resolve to detect breast cancer in early stages and save lives. These certifications enable us to expand our operations internationally and meet the strong global demand we are seeing for our novel solution,” said Dr. Geetha Manjunath, Founder & CEO, Niramai.

She also said that the startup is planning to collaborate with radiologists of the National Health Service and other key opinion leaders for an initial market testing in Europe, Africa, and Asia.

“In addition, we are in the process of partnering with more Indian healthcare providers for pan-India adoption,” Dr. Geetha added.

The startup has so far raised a total of $7 million from investors such as pi Ventures, Dream Incubator, Axilor Ventures, Ankur Capital, BeeNext, and others. 

Its solution has been already received 10 granted US patents, three Indian patents, as well as two Chinese and Singaporean patents. The startup has won many recognitions, including the Gold prize in Hack Osaka 2019, Aegis Grahambell Award, Frost and Sullivan Award among others.  

 In 2020, Niramai also bagged the National Startup Award in Healthcare Diagnostic category.