FDA greenlights intracranial hemorrhage AI
RapidAI has been cleared for U.S. marketing of updated AI-outfitted software that quickly detects or rules out acute brain hemorrhage on unenhanced CT.
The San Mateo, Calif.-based company says the latest release of its Rapid ICH product detects hemorrhages as small as 0.4 ml in volume and reduces false positives with 97% sensitivity and 100% specificity.
The software is designed to complement the company’s Rapid Hyperdensity product, which automatically quantifies and characterizes tissue to identify the location and volume of hyperdense regions, the company explains in an announcement posted Nov. 9.
Rapid AI adds that Rapid ICH prioritizes cases within radiology worklists and automatically notifies neuroradiologists of suspected hemorrhage via their preference of PACS, email or mobile app.
The announcement quotes neuroradiologist David Fiorella, MD, PhD, of Stony Brook Medicine.
“With the sheer number of CT scans performed daily, even relatively low rates of false positive ICH notifications can be disruptive and contribute to notification fatigue,” Fiorella says. “This degree of specificity is a remarkable achievement.”
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.