FDA Clears AI-Powered Module for Detecting Hemispheric Subdural Hematomas on CT

The Food and Drug Administration (FDA) has granted 510(k) clearance for RapidAI’s Rapid SDH, an artificial intelligence (AI)-enabled module that reportedly notifies radiologists of suspected hemispheric subdural hematomas within one minute of reviewing a computed tomography (CT) scan.

For suspected acute and chronic hemispheric subdural hematomas > 1 mL, the Rapid SDH module offers a sensitivity rate of 93 percent and a specificity rate of 99 percent, according to RapidAI.

In addition to flagging suspected cases of hemispheric subdural hematomas, RapidAI said the Rapid SDH module facilitates multidisciplinary collaboration for the management of these patients via automated notification sent via the RapidAI app, PACS and e-mail.

"The FDA's clearance of Rapid SDH significantly enhances our expanding range of hemorrhagic and trauma care solutions at this crucial time of rapidly growing patient numbers, clinician shortages, and advancements in potential treatment options,” said Amit Phadnis, the chief innovation and technology officer of RapidAI. “Our goal is to continue to expand the capabilities and applications of our deep AI to deliver comprehensive clinical solutions that provide care teams with the crucial insights necessary to evaluate patients, streamline decision making, and expedite care for this common and dangerous disease.”