RapidAI Garners Four New FDA Clearances For CT-Based AI Modules

The Food and Drug Administration (FDA) has granted four new 510(k) clearances for artificial intelligence (AI)-powered modules that will be available on the Rapid Enterprise Platform.

The cleared modules include Rapid LMVO, which offers adjunctive AI assessment of ischemic stroke, ranging from large vessel occlusion on non-contrast CT to advanced imaging evaluation, according to RapidAI, the developer of the modules. The company said Rapid DeltaFuse bolsters the visualization of subtle intracranial changes through automated alignment of serial non-contrast head CTs.

RapidAI noted the newly cleared Rapid MLS helps quantify midline shifts with potential brain injuries and RapidOH facilitates triage in suspected cases of obstructive hydrocephalus.

Rapid Aortic, which provides guideline-based measurements and automated 3D image reconstruction for AI-powered detection and tracking of aortic pathology, was cleared by the FDA earlier this month.

“The FDA clearances of these solutions underscore our commitment to deep clinical AI and reducing cognitive burden for radiologists, as well as supporting superior decision-making and outcomes,” said Karim Karti, the CEO of RapidAI. “RapidAI algorithms help set new standards by enabling radiologists to practice at the top of their license, reducing cognitive burden, and improving clinical decision-making for better outcomes in both acute and long-term settings.”