The ISO 13485 and MDSAP (Medical Device Single Audit Programme) international certifications endorse medical device manufacturers for their compliance with the international medical device quality standards and regulatory requirements. With these quality certifications, Niramai‘s Thermalytix solution can now be applied to all countries in Europe and will be applicable to many Asian, African and West Asian countries as well.
“These certifications enable us to expand our operations internationally and meet the strong global demand we are seeing for our novel solution,” said Niramai CEO Geetha Manjunath. “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.”
The solution and quality management processes were audited by an international notified body consisting of expert auditors from India, Germany and Australia. 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.
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.”
Another Niramai board member and investor from the Japanese venture capital firm 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.”
The Niramai solution has been granted 10 US patents, three Indian patents, and two Chinese and Singaporean patents.