Niramai, the deep-tech healthcare company offering an innovative AI-based, radiation-free breast cancer screening test has now received the 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 (EEA) as well as applicable to many Asian, African and Middle East countries. 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.
The test allows safe and accurate breast health checks in hospitals, screening camps and also at homes. Healthcare majors including HCG Hospital, Apollo Clinics, HealthSpring Diagnostics, among others use Niramai Thermalytix.
The high-resolution thermal sensing device captures thermal images and a cloud-hosted analytics solution uses proprietary machine learning-based software. 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 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.”
Manish Singhal, founding partner of pi Ventures and lead investor of Niramai said, Niramai's unique approach of detection of breast cancer using AI and thermal is a game-changer on how lives can be saved from breast cancer. 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.
Munehiko Eto, 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.”