NIRAMAI breast cancer screening test, Thermalytix, is a computer aided diagnostic engine that is powered by Artificial Intelligence. The solution uses a high resolution thermal sensing device and a cloud hosted analytics solution for analysing the thermal images for reliable, early and accurate breast cancer screening.
Thermalytix cancer screening test has been used by more than 100,000 women in 150+ hospitals/diagnostic center as well as 5000+ screening camps in India. The product is commercially available in India, UAE, Kenya, Philippines, Sweden, Bulgaria and Turkey. Niramai Thermalytix test has obtained a CE Mark for all European countries and regulatory clearance in the above countries.
Niramai Quality Management Processes are certified to be compliant with ISO 13485 and MDSAP. We follow good clinical practices, comply with information security and data privacy policies, as per EU GDPR and US HIPAA requirements.
Results of multiple clinical studies comparing Thermalytix with current standard of care have been published in peer reviewed conference/journals. The results from these clinical trials indicate very high accuracy of Thermalytix that is non-inferior to X-Ray Mammography in general, and 25% better sensitivity than mammography in women with dense breasts.
Some clinical studies and real world evaluations published in top peer reviewed journal publications are listed below.
- Study 1: BMJ Open Journal, https://pubmed.ncbi.nlm.nih.gov/34667011/
- Study 2: ASCO JCO Journal: https://pubmed.ncbi.nlm.nih.gov/33001739/
- Study 3: Frontiers in AI Journal, https://www.frontiersin.org/articles/10.3389/frai.2022.1050803/full
- Study 4: International Journal Of Community Medicine And Public Health https://www.ijcmph.com/index.php/ijcmph/article/view/10481
- Study 5: Lancet Oncology https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00419-3/fulltext
Complete list of Peer-Reviewed Publications in Medical and AI journals (Restricted Access)
The innovative methods used in our test have led to 31 Granted Patents, including 11 Granted US patents, 11 granted Indian patents, and rest granted in Japan, Singapore, China and Canada.