The clearances expand the company’s enterprise imaging platform across stroke, brain injury, hydrocephalus, and aortic assessment.
RapidAI has received US Food and Drug Administration (FDA) clearance for five new imaging modules, expanding the capabilities of its Rapid Enterprise Platform across neurology, vascular care, and longitudinal imaging analysis.
The newly cleared modules—Rapid DeltaFuse, Rapid LMVO, Rapid MLS, Rapid OH, and Rapid Aortic—are designed to support radiologists with automated analysis and measurement across a range of acute and follow-up clinical scenarios, from stroke and brain injury to aortic disease.
According to the company, the additions are intended to reduce manual interpretation work, standardize measurements, and support decision-making throughout the patient care pathway.
These new clearances are as follows:
- 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%.
- Rapid LMVO enables complete brain coverage (anterior, posterior, basilar, and distal territories) on CTA, extending innovation in ischemic stroke. Together with perfusion and non-contrast modules, Rapid offers a complete stroke solution from non contrast LVO detection to advanced imaging analysis with 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.
- 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.
- 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, inter-reader-free results, along with advanced automated 3D reconstruction and visualization. It also provides automated longitudinal comparisons and follow-up notifications.
“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,” says Karim Karti, CEO of RapidAI, in a release. “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.”
By pairing imaging precision with automation, the company says these new capabilities are designed to reduce interpretation time, eliminate manual measurement variability, and enhance collaboration across clinical disciplines.
“Deep clinical AI simplifies what used to be complex,” says Kiran Nandalur, MD, medical director at Corewell Health Radiology, in a release. “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, not data manipulation. This enables us to spend more time on decisions that impact patient care.”
Each module is fully into the Rapid Edge Cloud, a cloud-first IT platform with on-prem capabilities. Additionally, all modules are integrated into Rapid Navigator Pro, the company’s next-generation radiology solution, as well as the Rapid mobile and web applications.
ID 189779837 © Dzmitry Dzemidovich | Dreamstime.com
