FDA Clears Rapid Hyperdensity Tool for Inclusion in RapidAI Platform for Neurovascular Conditions

The FDA has cleared a new tool for RapidAI’s neurovascular artificial intelligence (AI) platform, called Rapid Hyperdensity, as part of the clinical decision support and patient workflow. Rapid Hyperdensity allows for quick assessment of injury severity among those with traumatic brain injury and brain hemorrhages, with a goal of improving and speeding up patient care decisions.¹

The tool uses noncontrast CT scans to evaluate the hyperdense tissue volume during the identification and assessment of intracerebral hemorrhage. In the hospital and mobile stroke unit settings, the Rapid Hyperdensity tool can provide additional contextual data to help inform triage and transfer decisions, which have been a top-of-mind area of focus in the clinical care of stroke and neurovascular conditions.

"As a neurosurgeon who treats many patients with intracranial hemorrhage (ICH), I am very excited for the recently approved Rapid Hyperdensity product that builds on the well-established RapidAI stroke platform,” Alejandro M. Spiotta, MD, director, Neuroendovascular Surgery Division, Medical University of South Carolina, said in a statement.¹ “Detection of ICH via AI can save lives by helping to speed up diagnosis and accelerate transfer to the best physician and hospital that can take care of the patient. With the addition of automatic hyperdense volume measurement, physicians can more easily track volume over time and help quickly identify which patients may require an intervention. This is an exciting time for those of us treating ICH."

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The benefits of this new addition to the RapidAI platform include the automatic detection of intracranial hyperdensities of less than 1 mL; the quick identification of hyperdensity volume to improve clinical hemorrhage management; and fast access to results via the Rapid mobile app, PACS/Workstation, or email, according to RapidAI. Karim Karti, CEO of RapidAI, said in a statement that the tool can importantly help clinicians in the crucial and early stages of head trauma and hemorrhagic stroke protocols.¹

“As the only comprehensive neurovascular decision support platform to offer this functionality, RapidAI aims to alleviate the enormous pressure of determining the best next course of action. This FDA clearance is a symbol of RapidAI’s ongoing commitment to push the boundaries of neurovascular care, while designing every product with physicians first in mind,” Karti said.¹

This news follows data announced earlier in 2022 that showed that the telehealth software had relatively high sensitivity and very high specificity in detecting ICH, as well as high accuracy in detecting high grade stenosis (HGS) and large vessel occlusion (LVO). Presented at the 2022 International Stroke Conference (ISC), held February 9-11, in New Orleans, Louisiana, the data included 2 abstracts: the first from a study of 1388 patients, 1251 from the emergency department (ED) and 137 inpatients who received head CTs on the ED scanner at a level 1 trauma center;² and the second study evaluated Rapid LVO, another subtool of RapidAI, on its ability to detect LVO and its impact treatment time and clinical outcomes, and included 1203 patients presenting with stroke symptoms who received CTAs with Rapid LVO were included.³

During ISC, Russell Cerejo, MD, vascular neurologist, Allegheny Health Network, and an author on the studies, told NeurologyLive^® that the benefit of RapidAI is that "it sort of bypasses the radiologist and spits out the results to a phone or the back system. Obviously, the radiologist reads the scan over to confirm that’s what we’re seeing, but it’s so quick and takes somewhere less than a minute to get the scan to your phone to tell you if there’s bleeding in the brain or if there’s large vessel occlusion. That can help expedite stroke therapy."

REFERENCES
1. RapidAI Receives FDA Clearance for Rapid Hyperdensity. News release. RapidAI. July 21, 2022. Accessed July 21, 2022. https://www.rapidai.com/press-release/rapid-hyperdensity
2. Chang W, Eisenmenger L, Cerejo R, Li C, Goldberg MF. Artificial intelligence for automated detection of intracranial hemorrhage (Rapid ICH): initial clinical experience. Presented at: ISC 2022; February 9-11; New Orleans, LA. Poster WP129
3. Chang W, Eisenmenger L, Cerejo R, Li C, Goldberg MF. Artificial intelligence for automated detection of large vessel occlusion using relative vessel density (Rapid LVO): one year experience in a multihospital integrated delivery network. Presented at: ISC 2022; February 9-11; New Orleans, LA. Poster WMP68