RapidAI has received U.S. Food and Drug Administration (FDA) clearance for five imaging modules: Rapid DeltaFuse, Rapid LMVO, Rapid MLS, Rapid OH, and Rapid Aortic for measurement.
The FDA clearances mark a significant expansion of the company's Rapid Enterprise platform for neurology and vascular care, it said.
Each module is fully integrated into the Rapid Edge Cloud IT cloud-first platform with on-premise capabilities as well as Rapid Navigator Pro and the Rapid mobile and web applications. They are designed to work across PACS, EHR, and reporting systems.
Rapid DeltaFuse aligns and coregisters serial noncontrast head CTs to visualize intracranial changes, such as acute or chronic hemorrhages, solid masses, or ventricular changes. Rapid LMVO provides complete brain coverage (anterior, posterior, basilar, and distal territories) on CTA. Rapid MLS detects and quantifies suspected midline shift, a key indicator of brain injury, while Rapid OH identifies suspected obstructive hydrocephalus by detecting cerebrospinal fluid accumulation in the lateral ventricles and generates alerts to expedite triage and transfer decisions.
Rapid OH also qualifies for the U.S. Centers for Medicare and Medicaid Services' (CMS) New Technology Add-on Payment (NTAP), the firm noted.
Rapid Aortic analyzes any CT scan that includes the aorta, including noncontrast and post-treatment studies, to help clinicians identify and track pathology from the arch to the iliacs. The Aortic Management module for Rapid Aortic also received FDA clearance this month.
