RapidAI Secures Five New FDA Clearances to Expand Deep Clinical AI Capabilities

RapidAI has announced U.S. Food and Drug Administration clearance for five new imaging modules—Rapid DeltaFuse™, Rapid LMVO, Rapid MLS, Rapid OH, and Rapid Aortic for measurement—marking a substantial expansion of the Rapid Enterprise Platform. The new clearances reinforce the company’s focus on deep clinical AI, designed to support acute triage, reduce cognitive burden, and improve longer-term patient management through characterization, quantification, visualization, and follow-up analysis.

The additions highlight RapidAI’s strategy to extend beyond point-in-time triage by enabling clinicians to track disease progression and make more informed decisions across the care continuum. Rapid DeltaFuse supports longitudinal patient management by aligning and co-registering serial non-contrast head CT scans to detect subtle intracranial changes, with studies showing a reduction of radiologist comparison time by more than 36%. Rapid LMVO provides complete brain coverage on CTA across all major territories, complementing perfusion and non-contrast modules to form a comprehensive stroke imaging suite.

Rapid MLS offers automated detection and quantification of suspected midline shift with a mean absolute error of 0.8 mm, supporting early identification of brain injury. Rapid OH detects suspected obstructive hydrocephalus in under one minute and qualifies for the CMS New Technology Add-on Payment. Rapid Aortic analyzes CT scans that include the aorta, producing guideline-based measurements, 3D reconstructions, and automated longitudinal comparisons to support surgical planning and follow-up.

Karim Karti, CEO of RapidAI, stated that “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.” The company emphasized that pairing imaging precision with automation enables faster interpretation, reduces manual variability, and strengthens collaboration across specialties.

Kiran Nandalur, MD, Medical Director at Corewell Health Radiology, said, “Deep clinical AI simplifies what used to be complex,” noting that automated visualization and quantification allow clinicians to focus on clinical judgment rather than manual measurement tasks.

All modules are integrated into Rapid Edge Cloud, providing cloud-first architecture with on-premises capability, and are accessible through Rapid Navigator Pro as well as the company’s mobile and web applications. This integration allows radiologists to review, compare, and act on findings within existing PACS, EHR, and reporting workflows.

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