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Niramaiâs breast cancer screening test receives CE mark approval Niramaiâs breast cancer screening test receives CE mark approval 06 April 2021 | News NIRAMAIâs Thermalytix solution can now be applied to all countries of Europe, as well as applicable to many Asian, African and Middle-East countries. Niramai, the deep-tech healthcare company at Bengaluru 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 Programme) 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. ....