iSchemaView, the worldwide leader in advanced imaging for stroke, has received approval from AMAR (Israel’s Ministry of Health medical device regulation unit), for the use of the RAPID imaging platform across the State of Israel.
This approval follows use and clearance of the iSchemaView RAPID technology across several of the founding Global Harmonization Task Force (GHTF) regions, including Australia, Canada, the United States and the EU. RAPID is designed to provide physicians with fast, fully automated, and easy-to-interpret imaging that facilitates clinical decision-making around stroke.
Hospitals and clinics that treat ischemic stroke in Israel will now have access to RAPID’s automated CTP, MR, CTA and ASPECTS solutions, as well as their unique mobile app that accelerates the provision of information to support treatment decision making. RAPID’s expansion into Israel represents continued market growth across the Middle East, and is further confirmation that RAPID has become the de facto standard for stoke imaging around the world.
“By having RAPID’s AI-powered imaging technology available in Israel we will be able to help tens of thousands of stroke suffering citizens in a way that was previously impossible,” says Simon Canham, iSchemaView Vice President & General Manager EMEA. “Moving forward we will be able to help better identify the best routes of care for patients, improving their chances of recovery and quality of life.”
Developed by leading stroke experts, RAPID technology has been selected for use in several groundbreaking 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, SMS/MMS, the RAPID app or corporate partner workflow systems.
Unique in the comprehensive depth and range of its clinical validation, RAPID is also the imaging standard in stroke research. iSchemaView’s imaging solution now has a research footprint across more than 300 stroke centers and more than 10 large-scale international 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, and has been granted FDA clearance for selection of patients for both early and late window thrombectomy.
The Complete RAPID Platform includes:
RAPID MRI, which provides fully automated, easy to interpret diffusion and perfusion maps that identify brain areas with low ADC values, as well as delayed contrast arrival. RAPID MRI perfusion automatically quantifies regions of reduced cerebral blood flow, volume and transit time that exceed pre-specified thresholds.
RAPID CTP, which automatically quantifies regions of reduced cerebral blood flow, volume and transit time that exceed pre-specified thresholds. Regions are color coded and the volumes of interest are automatically measured. Maps (including mismatch maps) of the severity of Tmax delays are provided using a four-color-coded scale.
RAPID CTA, which automatically provides clear, easy-to-interpret CTA maps that include a colored overlay to identify brain regions with reduced blood vessel density. The severity of reduction can be readily visualized by a simple, four-color-coded scale. Additionally, a 3D reconstruction of the vasculature allows physicians to rotate the image for optimal viewing of the vessels from multiple angles.
RAPID ASPECTS, which automatically generates a standardized score — based on clinically validated machine learning algorithms — that enables physicians to easily communicate about the extent of a patient’s ischemic changes and to determine eligibility for thrombectomy (clot removal). In addition, RAPID ASPECTS provides clear visualization of the brain so that clinicians can better scrutinize each region and confirm the automated score.
“With approval for RAPID in Israel we continue to greatly expand the number of health care facilities around the world that are able to assess stroke patients with the only clinically validated next-generation imaging technology,” said Don Listwin, CEO of iSchemaView. “Across the globe, stroke centers are now delivering over 250,000 RAPID cases a year. We are excited that we can bring RAPID to Israel and give more hospitals the tools they need to best help their patients and improve outcomes.”
Source: Company Press Release.