NIRAMAI Health Analytix Receives CE Mark Approval – Set To Go Global

Bengaluru, 06, April 2021: Niramai, the deep-tech healthcare firm providing an progressive AI-based, radiation-free breast most cancers screening take a look at has now acquired the celebrated CE Mark Approval, ISO 13485 and MDSAP (Medical Device Single Audit Program) International Certifications. The CE mark Approval signifies that the product could also be offered freely in any a part of the European Economic Area. The ISO 13485 and MDSAP certifications endorse medical system producers for his or her compliance with the worldwide medical system high quality requirements and regulatory necessities.

NIRAMAI’s Thermalytix™ Solution and high quality administration processes had been audited by a global notified physique consisting of professional auditors from India, Germany and Australia. This CE mark approval exhibits that the product meets EU necessities for medical units below MDD93/42/EEC for security, and efficiency. With these high quality certifications, NIRAMAI’s Thermalytix resolution can now be utilized to all nations of Europe, in addition to relevant to many Asian, African and Middle East nations.

NIRAMAI Thermalytix™ take a look at is revolutionizing breast well being screening by enabling privacy-aware, protected and correct breast well being checks in hospitals, in screening camps and in addition at houses. NIRAMAI Test is already being utilized in famend hospitals and clinics throughout varied Indian cities, together with HCG Hospital, Apollo Clinics, HealthSpring Diagnostics, amongst others. NIRAMAI Thermalytix™ resolution makes use of a high-resolution thermal sensing system to seize thermal photographs and a cloud-hosted analytics resolution for analysing these thermal photographs utilizing proprietary machine learning-based software program for dependable, early and correct breast most cancers screening. The take a look at has been clinically validated to indicate higher sensitivity than mammography and the validation outcomes have been printed in reputed worldwide venues just like the American Society of Clinical Oncology (ASCO) and San Antonio Breast Cancer Symposium (SABCS). NIRAMAI has additionally acquired a number of prestigious awards, together with the National Startup Award for 2020 in Healthcare Diagnostic class.

Dr. Geetha Manjunath, Founder and CEO of NIRAMAI feedback, “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.”

Investors of NIRAMAI are additionally enthusiastic about this information. Manish Singhal, Founding Partner of pi Ventures and lead investor of NIRAMAI mentioned, Niramai’s distinctive strategy of detection of breast most cancers utilizing AI and thermal is a game-changer on how lives could be saved from breast most cancers. With the ISO and CE certification, now Thermalytix could be made obtainable to ladies past India particularly in total Europe, Middle East and a number of other nations in Southeast Asia resulting in international influence. We are tremendous excited to take this know-how to the world.

Another NIRAMAI board member and investor from the Japanese VC Firm, Dream Incubator, Munehiko Eto, mentioned “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”.


NIRAMAI is a deep-tech startup providing a radiation-free, non-invasive, non-touch, breast most cancers screening resolution for hospitals and diagnostic centres. The resolution is correct, reasonably priced, privacy-aware, and can be utilized for ladies of all ages. NIRAMAI resolution has been awarded 10 granted US patents, 3 Indian patents, 2 Chinese and Singapore patents. Niramai has received many recognitions, together with the Gold prize in Hack Osaka 2019, Aegis Grahambell Award, Frost and Sullivan Award, choice to Google Launchpad, Philips Healthworks, Nvidia Inception, BIRAC WinER, Elevate 100, challenge help from Bill and Melinda Gates Foundation and the CDC-United Kingdom. NIRAMAI is the one Indian firm listed on the 2019 Top AI 100 startups on the planet introduced by CB Insights. NIRAMAI was additionally the winner of the National Startup Award 2020 within the Healthcare Diagnostics Category. NIRAMAI has raised a complete of seven Million USD from traders akin to piVentures, Dream Incubator, Axilor Ventures, Ankur Capital, BeeNext and others.



Please enter your comment!
Please enter your name here