iSchemaView’s RAPID™ Approved for Use in Brazil

iSchemaView Expands RAPID’s South American Footprint by Bringing
Brazil the Only Clinically Validated, Next-Generation Imaging Platform
for Assessing Ischemic Stroke

MENLO PARK, Calif.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/irapid?src=hash” target=”_blank”gt;#irapidlt;/agt;–iSchemaView, the worldwide leader in advanced imaging for stroke, has
received approval from ANVISA (the Brazilian Health Regulatory Agency),
for the use of the RAPID imaging platform across Brazil. RAPID is
designed to provide physicians with fast, fully automated, elegant and
easy-to-interpret imaging that facilitates clinical decision-making
around stroke. The approval comes after iSchemaView’s quality system was
also certified through the Medical Device Single Audit Program (MDSAP) —
a global approach to auditing and monitoring the manufacturing of
medical devices, in an effort to improve safety and oversight on an
international scale.

Hospitals and clinics that treat ischemic stroke in Brazil will now have
access to RAPID’s automated CTP, MR, CTA and ASPECTS solutions. RAPID’s
expansion into Brazil represents significant market growth in South
America, and is another sign that RAPID has become the de facto standard
in stoke imaging around the world.

“RAPID signifies the massive leaps medical technology has made in the
last two years to better diagnose and treat stroke patients,” said Dr.
Francisco Mont’Alverne, MD, PhD, Director of Interventional
Neuroradiology Hospital Geral de Fortaleza. “This ANVISA clearance
means hundreds of thousands of Brazilians may now benefit from RAPID’s
state-of-the-art, AI-powered imaging technology.”

Developed by leading stroke experts, 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.

“Patients often arrive at the hospital several hours after stroke
symptom onset,” said Dr. Fabricio Oliveira Lima, MD, MPH, PhD, Director
of the Stroke Unit Neurology Service Hospital Geral de Fortaleza. “RAPID
allow us to see the status of the brain upon arrival and to quickly
identify patients who are eligible for clot removal, even as late as 24
hours after stroke onset. This increases the chances for recovery for
our patients, reduces disability and saves lives.”

The Complete RAPID Platform includes:

  • RAPID MRI 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 CT perfusion 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 automatically provides clear, easy to interpret CTA
    maps which 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 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.

“Over 1,000 stroke centers in more than 40 countries across North
America, South America, Europe, Asia and Australia have committed to
using the RAPID platform for stroke imaging,” said Don Listwin, CEO of
iSchemaView. “We are excited we can now bring RAPID to Brazil, give
hospitals of all sizes the tools they’ve needed, and help address more
patients than ever before. In addition, we have secured the support of
some of the best RAPID experts in Brazil to provide clinical training.”

For more information about working with RAPID in Brazil, contact info@irapid.com.

About iSchemaView

iSchemaView is the world-wide leader in advanced imaging for stroke.
Installed in over 1,000 stroke centers, iSchemaView’s RAPID (automated
CTP, MR, 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. For more information, visit www.iRAPID.com.

Contacts

Peter Evers
Natron Communications
(415) 524-8899
pr@irapid.com

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