RapidAI’s Rapid ICH Product Cleared by FDA for Intracranial Hemorrhage Management

November 9, 2022—RapidAI announced it has received FDA 510(k) clearance for the latest release of Rapid ICH, the company’s intracranial hemorrhage (ICH) triage and notification product.

According to the company, the Rapid ICH provides 97% sensitivity and 100% specificity to support physicians’ ability to address ICH management accurately and comprehensively.

Rapid ICH uses artificial intelligence to quickly analyze noncontrast CT scans and notify clinicians of possible hemorrhage. Then, the company’s Rapid Hyperdensity technology automatically quantifies and characterizes tissue to identify the location and volume of hyperdense regions.

This additional contextual data helps physicians at hospitals and mobile stroke units make more informed triage and transfer decisions, stated the company.

RapidAI outlined the following key benefits of Rapid ICH: detects suspected ICH as small as 0.4 ml in volume; prioritizes cases within the radiology worklist; streamlines decision making by automatically sending notifications of suspected ICH to PACS, email, and the Rapid mobile app; and reduces the number of false positives, addressing the concern of “notification fatigue” for physicians.

David Fiorella, MD, a neuroradiologist at Stony Brook Medicine in Stony Brook, New York, commented in RapidAI’s press release, “With the sheer number of CT scans performed daily, even relatively low rates of false positive ICH notifications can be disruptive and contribute to notification fatigue. The latest release of Rapid ICH essentially eliminates false positives and gives physicians a high degree of confidence to make critical decisions about patients with acute brain hemorrhages. This degree of specificity is a remarkable achievement.”