Radiology AI vendor Bot Image may market its prostate software not only for diagnosing cancer when suspected but also for performing prostate screenings.
The March 28 approval follows the product’s initial approval last summer, when Bot Image secured the FDA’s go-ahead for diagnostic use cases.
The expanded clearance for the software, called ProstatID, allows its use with bi-parametric MRI for unenhanced and expedited scans.
Bot Image says its algorithm achieved 93.6% accuracy and improved physician performance in the company’s own clinical trials.
The company says the newly OK’d capability has “huge implications for men’s health and for healthcare costs savings by being a highly accurate tool for active surveillance—meaning conducting periodic low-cost MRI scans supplemented with the AI interpretation of ProstatID.”
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.