FDA greenlights portable, wearable 3D breast POCUS
The U.S. Food and Drug Administration has approved a point-of-care ultrasound system that captures 3D images of whole breasts in two minutes without assistance from a sonographer or other expert human operator: The patient wears the device while the machine essentially operates itself.
San Francisco-based iSono Health announced the nod May 3, saying its ATUSA system features AI software that automatically analyzes the images the device acquires.
The system is aimed at breast radiologists who would offer patients its use as an in-office POCUS service, iSono suggests.
The announcement quotes radiologist Mohammad Eghtedari, MD, PhD, of UC-San Diego, who says such automated and versatile technology “will improve access to breast care for women worldwide and empower physicians with insightful data to make more informed clinical decisions.”
iSono says its R&D pipeline contains similar products, all of which will leverage ATUSA’s advanced algorithms to help clinicians detect and classify breast lesions.
iSono ATUSA’s FDA 510(k) premarket notification posted 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.