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RapidAI touts five new FDA clearances ahead of RSNA

by Gus Iversen, Editor in Chief | November 30, 2025
Artificial Intelligence
RapidAI has received U.S. Food and Drug Administration (FDA) clearance for five new imaging modules, expanding its clinical decision-support portfolio across neurology and vascular care. The new tools — DeltaFuse, LMVO, MLS, OH, and Aortic for measurement — extend the capabilities of the company's Rapid Enterprise platform.

The new modules are designed to support radiologists and physicians in evaluating conditions such as intracranial hemorrhage, stroke, midline shift, hydrocephalus, and aortic pathology. All five modules are integrated into RapidAI’s cloud-based platform, with access via desktop, mobile, and web applications.

Rapid DeltaFuse helps enable longer-term patient management by automatically aligning and co-registering serial non-contrast head CTs to visualize subtle intracranial changes, such as acute or chronic hemorrhages, solid masses, or ventricular changes. Studies have shown that DeltaFuse reduces radiologist comparison time by over 36%.
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Rapid LMVO enables complete brain coverage (anterior, posterior, basilar, and distal territories) on CTA, extending Rapid’s leadership and innovation in ischemic stroke. Together with perfusion and non-contrast modules, Rapid offers the only complete stroke solution for the entire patient journey from non-contrast LVO detection all the way to advanced imaging analysis with the only CT and MR Perfusion analysis clinically validated in randomized clinical trials.

Rapid MLS detects and quantifies suspected midline shift, a key indicator of brain injury, delivering objective visualization with a mean absolute error of just 0.8 mm, helping clinicians identify meaningful shifts earlier.

Rapid OH identifies suspected obstructive hydrocephalus by detecting cerebrospinal fluid accumulation in the lateral ventricles and generating alerts in under one minute to expedite triage and transfer decisions. Rapid OH also qualifies for the CMS New Technology Add-on Payment (NTAP), underscoring its clinical and economic value.

Rapid Aortic analyzes any CT scan that includes the aorta, including non-contrast and post-treatment studies, to help clinicians identify and track pathology from the arch to the iliacs. It delivers guideline-based measurements with consistent, interreader-free results, along with advanced automated 3D reconstruction and visualization for confident surgical planning. Automated longitudinal comparisons and follow-up notifications simplify surveillance, reduce variability, and save care teams time.

“Deep clinical AI simplifies what used to be complex,” said Dr. Kiran Nandalur, medical director of radiology at Corewell Health. “By automatically calculating and visualizing changes we once did manually, RapidAI can reduce the cognitive burden and allow us to concentrate on clinical judgment and interpretation.”

All five modules are integrated into RapidAI's Navigator Pro platform and are designed to function across PACS, EHRs, and reporting systems without disrupting radiology workflows. The company says this unified approach aims to streamline acute and longitudinal care through more consistent imaging insights.

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