Nanox Receives FDA Clearance for HealthCCSng V2.0, Upgraded Version of Advanced AI Cardiac Solution Empowering Physicians in Assessment of Coronary Artery Calcium
21 August 2024 - 10:00PM
NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an
innovative medical imaging technology company, today announced that
its deep-learning medical imaging analytics subsidiary, Nanox.AI,
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for HealthCCSng V2.0.
HealthCCSng V2.0 is the upgraded version of Nanox.AI’s cardiac
solution, HealthCCSng, which has already shown tangible results in
several healthcare systems, identifying patients at high risk of
coronary artery disease while driving significant revenue to
cardiology departments. It has also been seamlessly integrated with
existing picture archiving and communication systems (PACS) and
electronic medical records (EMR) systems, and enabled timely and
appropriate preventive care.
HealthCCSng utilizes medical imaging data from routine
non-gated, non-contrast CT scans that include the entire heart of
adult patients of ages 30-85 to automatically measure coronary
artery calcium (CAC), which is the number one risk predictor for a
future cardiovascular event. The product aims to leverage the high
utilization of CT scans in the medical care environment, including
lung cancer screening programs, to automatically detect
calcification in the coronary arteries of patients in an
opportunistic manner. Patients with the highest category of CAC
levels are over 13 times more likely to suffer a cardiac event.
The device output is available to radiologists as part of their
standard workflow. A list of studies that received a successful
algorithm analysis result will also be available for further
clinical assessment by cardiologists, general practitioners and
other medical professionals.
HealthCCSng V2.0 introduces the following features that improve
its ability to inform physicians and help them conduct the most
appropriate risk assessment and subsequent preventative healthcare
for patients:
- Zero CAC
Category: HealthCCSng now enables
clinicians to easily distinguish between patients with zero and low
CAC levels. CAC levels of zero are associated with very low risk of
cardiac events. The new zero CAC category joins the previously
featured ‘low’, ‘medium’ and ‘high’ CAC categories.
- Numerical CAC
Scoring: HealthCCSng now provides the numerical
CAC score alongside the CAC category in its results interface,
allowing clinicians to finetune their cardiac risk assessments of
patients.
- CAC Category Configuration: HealthCCSng now
enables users to adjust the lower and upper bounds for the low
(1-99 Hounsfield units (HU) by default), medium (100-399 HU by
default) and high (400+ HU by default) categories of CAC scores.
This added customization allows users to finetune their cardiac
risk assessments of patients.
“We are pleased to receive another regulatory clearance from the
FDA for our AI cardiac solution, with new updates that reflect our
commitment to providing healthcare professionals with the tools
they need,” said Erez Meltzer, Nanox Chief Executive Officer. “The
AI cardiac solution helps to bridge the divide between radiology
and cardiology, two medical specialties that often use different
terms and descriptions to assess imaging data, and catches patients
who might otherwise fall through the cracks so that they can be
directed to appropriate preventative healthcare. We will continue
exploring opportunities to seamlessly integrate our AI solutions
with healthcare systems and clinician workflows, and ultimately
enhance patient care and outcomes.”
About Nanox.AINanox.AI is the deep-learning
medical imaging analytics subsidiary of Nanox. Nanox.AI solutions
are developed to target highly prevalent chronic and acute diseases
affecting large populations around the world. Leveraging AI
technology, Nanox.AI helps clinicians extract valuable and
actionable clinical insights from routine medical imaging that
otherwise may go unnoticed, potentially initiating further medical
assessment to establish individual preventative care pathways for
patients. For more information, please
visit https://www.nanox.vision/ai.
About NanoxNanox (NASDAQ:
NNOX) is focused on applying its proprietary medical imaging
technology and solutions to make diagnostic medicine more
accessible and affordable across the globe. Nanox’s vision is to
increase access, reduce costs and enhance the efficiency of routine
medical imaging technology and processes, in order to improve early
detection and treatment, which Nanox believes is key to helping
people achieve better health outcomes, and, ultimately, to save
lives. The Nanox ecosystem includes Nanox.ARC— a multi-source
Digital Tomosynthesis system that is cost-effective and
user-friendly; an AI-based suite of algorithms that augment the
readings of routine CT imaging to highlight early signs often
related to chronic disease (Nanox.AI); a cloud-based infrastructure
(Nanox.CLOUD); and a proprietary decentralized marketplace, through
Nanox’s subsidiary, USARAD Holdings Inc., that provides remote
access to radiology and cardiology experts; and a comprehensive
teleradiology services platform (Nanox.MARKETPLACE). Together,
Nanox’s products and services create a worldwide, innovative, and
comprehensive solution that connects medical imaging solutions,
from scan to diagnosis. For more information, please visit
www.nanox.vision.
Contacts
Media Contact:Ben ShannonICR
WestwickeNanoxPR@icrinc.com
Investor Contact:Mike CavanaughICR
Westwickemike.cavanaugh@westwicke.com
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