Total knee AI/AR cleared for sales in the US

The FDA has granted 510(k) clearance to a French startup for surgery software that combines AI with augmented reality and computer vision.

Pixee Medical says its Knee+ helps orthopedic surgeons position instruments in real time and within the surgeon’s field of view, facilitating better and faster total knee replacements.

The company says the system has sold briskly in Europe and Australia, where it has caused changes in operating technique among only 10% of surgeons for whom Knee+ represents an introduction to real-time digital assistance.

The system uses smart glasses for its AR interface. CEO Sébastien Henry says Pixee plans to build out its platform for hip and shoulder replacements.

Announcement here, animated video demonstration 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?