Home

RapidAI Extends the Reach of Deep Clinical AI with Five New FDA Clearances

via Business Wire

New clearances expand the Rapid Enterprise Platform, advancing radiology precision, and elevating neurology and vascular care through deep clinical AI

RapidAI, the pioneer of deep clinical AI and global leader in enterprise imaging, today announced the U.S. Food and Drug Administration (FDA) clearance of five new imaging modules: Rapid DeltaFuse™, Rapid LMVO, Rapid MLS, Rapid OH, and Rapid Aortic for measurement. Together, these clearances mark a significant expansion of the Rapid Enterprise™ Platform, reinforcing RapidAI’s identity as the only platform purpose-built to bring deep clinical intelligence, seamless workflow integration, and secure IT infrastructure to hospitals worldwide.

RapidAI is committed to building deep clinical AI—algorithms that not only can triage and find more diseases, but also reduce cognitive burden for radiologists, support acute patient treatment and transfer decisions, and enable improved longer-term patient management. RapidAI accomplishes this by pursuing AI that goes beyond simple triage, enabling physicians to characterize, quantify, visualize, and track changes over time.

These new clearances reaffirm RapidAI’s unique approach to building clinical depth to support decision-making across the entire patient journey, not just at the point of initial triage.

  • 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%.1
  • 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, inter-reader-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.

“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, 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.”

By pairing imaging precision with automation, these new capabilities reduce interpretation time, eliminate manual measurement variability, and enhance collaboration across clinical disciplines. The result is not just faster imaging, it’s a more innovative, more connected model of care that helps hospitals see earlier, decide faster, and act with confidence.

“Deep clinical AI simplifies what used to be complex,” said Kiran Nandalur, MD, Medical Director, Corewell Health Radiology. “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 integrated into the Rapid Edge Cloud, the cloud-first IT platform with on-prem capabilities that ensures continuous service during any disruptions. Additionally, all modules are seamlessly integrated into Rapid Navigator Pro™, the company’s next-generation radiology solution, as well as the Rapid mobile and web applications. Together, they create a seamless and secure experience across PACS, EHR, and reporting systems, allowing radiologists to access, compare, and act on critical findings without workflow disruption.

About RapidAI

RapidAI is the trusted leader in deep clinical AI, helping hospitals deliver faster, more informed care through intelligent imaging and integrated workflows. The Rapid Enterprise™ Platform supports disease states across the care spectrum, but it’s our clinical depth that drives the most meaningful impact—improving decision-making, patient outcomes, and health system performance.

Used by more than 2,500 hospitals in over 100 countries and backed by 700+ clinical studies, including research that helped expand national stroke-treatment guidelines, RapidAI is the most clinically validated AI platform in healthcare.

Discover the value of clinical depth at scale at rapidai.com.

1 Montouri J, et al., Improved radiology review time and accuracy with the Rapid DeltaFuse™ platform for head CT scan comparisons [abstract]. ASNR 2025, Atlanta, GA

New capabilities reduce interpretation time, eliminate manual measurement variability, and enhance collaboration across clinical disciplines.

Contacts