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Niramai receives CE Mark approval, set to go global

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Plans to collaborate with radiologists of the National Health Service and other key opinion leaders for an initial market testing in Europe, Africa and Asia

Niramai, the deep-tech healthcare company offering an AI-based, radiation-free breast cancer screening test has now received the CE Approval, ISO 13485 and MDSAP (Medical Device Single Audit Program) International Certifications.

As per a release, 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 promotes breast health screening by enabling privacy, safe and accurate breast health checks in hospitals, in screening camps and also at homes. According to a media handout, it is already being used in 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 reportedly 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).

Commenting on how this certification impacts the company Dr Geetha Manjunath, Founder and CEO, Niramai said, “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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