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.

Dave Pearson

Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.

Around the web

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns. 

One product is being pulled from the market, and the other is receiving updated instructions for use.

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?