FDA greenlights ultrasound MSK software with AI
Clarius Mobile Health of Vancouver, B.C., has won FDA approval to market an AI model that works with the company’s handheld point-of-care ultrasound devices to identify and measure tendons of the foot, ankle and knee.
Clarius says its MSK AI product homes in on and highlights the patellar, Achilles and plantar fascia tendons, enabling users to make point-of-care clinical decisions as well as educate trainees.
The software places virtual moveable calipers corresponding to the thickest points in the top and bottom of the tendon under examination, displaying as a transparent overlay on a mobile device.
In a Feb. 1 news release announcing the FDA clearance, the company offers that its handheld scanners start at $3,395 USD with a $595 annual membership.
The release quotes orthopedic surgeon and sports medicine specialist Alan Hirahara, MD, of Sacramento, Calif., an early tester of Clarius’s newly approved AI model.
“In research, interobserver variability exists for any measurement of structures,” Hirahara says. “With the AI standardization of measurements, interobserver reliability problems will now be non-existent. I am excited to see where this technology will go as Clarius continues to innovate.”
Clarius president and CEO Ohad Arazi calls AI automation “the new frontier,” adding “we’re excited to be the world’s first to receive FDA clearance to use AI for musculoskeletal ultrasound.”
Full announcement here.
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.