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NIRAMAI receives CE Mark approval

The company plans to sell the product freely in any part of the European Economic Area

Niramai, a health tech company offering an innovative 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. The CE mark Approval indicates that the product may be sold freely in any part of the European Economic Area. The ISO 13485 and MDSAP certifications endorse medical device manufacturers for their compliance with the international medical device quality standards and regulatory requirements.

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NIRAMAI’s Thermalytix Solution and quality management processes were audited by an international notified body consisting of expert auditors from India, Germany and Australia. This CE mark approval shows that the product meets EU requirements for medical devices under MDD93/42/EEC for safety, and performance. With these quality certifications, NIRAMAI‘s Thermalytix solution can now be applied to all countries of Europe, as well as applicable to many Asian, African and Middle East countries.

NIRAMAI Thermalytix solution uses a high-resolution thermal sensing device to capture thermal images and a cloud-hosted analytics solution for analysing these thermal images using proprietary machine learning-based software for reliable, early and accurate breast cancer screening. The test has been clinically validated to show better sensitivity than mammography and the validation results have been published in international venues like the American Society of Clinical Oncology (ASCO) and San Antonio Breast Cancer Symposium (SABCS). 

Dr Geetha Manjunath, Founder and CEO, NIRAMAI, comments, “We plan to collaborate with renowned radiologists of the National Health Service (NHS) 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.”

Manish Singhal, Founding Partner of pi Ventures and lead investor of NIRAMAI said, “With the ISO and CE certification, now Thermalytix can be made available to women beyond India especially in entire Europe, Middle East and several countries in Southeast Asia leading to global impact. We are super excited to take this technology to the world.”

Another NIRAMAI board member and investor from the Japanese VC Firm, Dream Incubator, Munehiko Eto, said, “There is a strong global need for Niramai’s breakthrough technology innovation of AI-based screening solution for breast cancer, especially for women with dense breasts. NIRAMAI has continued to achieve success even in the challenging year of COVID-19. We are proud to have partnered with them.”

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