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Bengaluru-based healthtech startup Niramai Health Analytix’s AI-based, radiation-free breast cancer screening solution, Thermalytix™, has received CE mark approval, ISO 13485, and MDSAP (Medical Device Single Audit Programme) International Certifications.  

In an official statement, the startup revealed that the CE mark approval will now enable its product to be sold in any part of the European Economic Area. Meanwhile, the ISO 13485 and MDSAP certifications validate its international medical device quality standards and regulatory requirements compliance.

“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,” Dr Geetha Manjunath, Founder and CEO of Niramai, said in a statement. 

She adds that the startup is looking to collaborate with radiologists of the National Health Service (NHS) and other key opinion leaders for 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 said.

Founded in 2016, Niramai has developed an AI-based breast cancer screening solution. Thermalytix, a cloud-hosted analytics solution, uses big data analytics, artificial intelligence, and machine learning algorithms for early breast cancer screening.

Thermalytix™ solution mainly uses a high-resolution thermal sensing device to capture thermal images and a cloud-hosted analytics solution for analysing them and provide breast cancer screening. 

According to the startup, the solution is already being used in several hospitals and clinics, including HCG Hospital, Apollo Clinics, and HealthSpring Diagnostics among others, across the country.

To date, the startup has raised a total of $7 million from investors such as piVentures, 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.