RAPID Receives Registration Approval in Japan

iSchemaView, developer of advanced imaging for stroke, has received registration approval under the Japanese Pharmaceutical Affairs Law through third party review by the Japanese Association for the Advancement of Medical Equipment for its RAPID imaging platform. With this news the technology is available to hospitals across Japan, with the support of Micron, the Japanese RAPID distributor. RAPID is designed to provide physicians with fast, fully automated, and easy-to-interpret imaging that facilitates clinical decision-making around stroke.
 
“Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health burden on the country,” said Dr. Manabu Inoue from National Cerebral and Cardiovascular Center. “With RAPID’s AI-powered imaging technology we will be able to better address our patients to provide them with the best routes of care, improving their chances of recovery.”
 
Developed by leading stroke experts, RAPID technology has been selected for use in several ground-breaking trials that have changed treatment guidelines issued by both the American Heart Association and American Stroke Association. The RAPID Artificial Intelligence framework combines deep learning, machine learning and expert feature extraction. Together these provide unparalleled sensitivity and specificity across stroke modules (CT perfusion, MR diffusion and perfusion, CTA and CT ASPECT scoring). Results are then delivered by the RAPID Intelligence Services Platform via PACS, email, text, the RAPID app or corporate partner workflow systems.
 
The Complete RAPID Platform includes:
 
● RAPID CTP: fully-automated perfusion maps; accurately quantifies reduced cerebral blood flow, cerebral blood volume and transit time
● RAPID MRI: fully-automated diffusion and perfusion maps that quantify brain areas with low ADC values, as well as delayed contrast arrival
● RAPID CTA: automatically delivers CT angiography maps and identifies brain regions with reduced blood vessel density in 2D and 3D outputs
● RAPID ASPECTS: automatically identifies areas of early ischemic change on non-contrast CT scans, which predicts irreversible injury
● RAPID Mobile App: Securely review RAPID results from multiple sites with customizable notifications
 
“With approval for RAPID in Japan, we extend a global footprint that gives more hospitals the tools they need to help stroke patients achieve the best outcomes and quality of life,” said Anil Singhal, M.D., senior vice president, Worldwide Operations, at iSchemaView. “Our goal is to help as many stroke patients as possible by delivering the only clinically validated, next-generation imaging technology available.”
 
RAPID develops advanced imaging for stroke. Installed in over 1,200 hospitals, RAPID (automated CTP, MRI, CTA and ASPECTS), with enhanced AI framework, is the most advanced stroke imaging platform. In clinical trials, RAPID has been shown to aid in the selection of patients in early and late-window stroke trials, including SWIFT PRIME, EXTEND IA, DAWN, DEFUSE 3 and EXTEND. In addition to achieving the best clinical outcomes and largest treatment effects ever obtained, these landmark studies led to new American Heart Association and American Stroke Association guidelines and have dramatically altered the management of acute stroke around the world.
 
Micron is a Japanese imaging contract research organization and provides clinical trial support services with expertise in medical image handling. Micron offers a wide range of services, including imaging protocol standardization, image analysis, site management, and clinical monitoring to enhance the efficiency, reproducibility, and reliability of clinical trials. The company also engages in the development, sales, and marketing of the imaging analysis software which can be utilized in clinical trials for evaluating the efficacy or safety of drugs and in clinical disease progression. RAPID is one of such software, and was approved as a medical device by Pharmaceutical Affairs Law successfully in a short period of time with the great contribution of Micron.