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Niramai, the deep-tech healthcare company offering an innovative AI-based, radiation-free breast cancer screening test has now received the prestigious 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.

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™ test is revolutionizing breast health screening by enabling privacy-aware, safe and accurate breast health checks in hospitals, in screening camps and also at homes. NIRAMAI Test is already being used in renowned hospitals and clinics across various Indian cities, including HCG Hospital, Apollo Clinics, HealthSpring Diagnostics, among others. 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 reputed international venues like the American Society of Clinical Oncology (ASCO) and San Antonio Breast Cancer Symposium (SABCS). NIRAMAI has also received several prestigious awards, including the National Startup Award for 2020 in Healthcare Diagnostic category.

Dr. Geetha Manjunath, Founder and CEO of NIRAMAI comments, “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. Moving forward, 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.”



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