Thermal imaging–AI breast cancer exam cleared for sales in Europe

The European Union has granted CE mark approval to a breast cancer screening system that combines a thermal imaging device with cloud-hosted AI analytics.

Bengaluru, India-based Niramai says that, in clinical trials, its newly approved Thermalytix system bested mammography on sensitivity. It also says the system can be used in homes as well as in professional healthcare settings.

Niramai says its software has received 10 patents in the U.S., three in India and two in China.

The company adds that Thermalytix can now help women aim for early diagnosis or cancer rule-out not only across the European Economic Area but also in “many Asian, African and Middle East countries.” News release here.

Also receiving a nod from the EU this month is Netherlands-based Quantib, whose AI prostate package earned FDA approval last fall. April Quantib news release here.