Spectral Submits Application for UKCA Mark Classification
29 Januar 2024 - 3:33PM
Spectral MD, Inc. (“SMD”), a subsidiary of Spectral AI,
Inc. (NASD: MDAI; MDAIW) (“Spectral AI” or the
“Company”), an artificial intelligence
(AI) company focused on medical diagnostics for faster and more
accurate treatment decisions in wound care, today announced the
submission of an application in the United Kingdom for its
predictive software DeepView AI®-Burn to be registered as UK
Conformity Assessed (UKCA) for burn wound use in the UK.
“We are pleased to reach this milestone towards
the initial commercialization opportunity for our DeepView AI®-Burn
algorithm, which contains our first AI software release that can be
used for assessment and management of thermal burn wounds,” said
Niko Pagoulatos, Ph.D., Chief Operating Officer of Spectral AI. "We
look forward to hearing about our application in the first half of
2024.”
There is currently no diagnostic tool in the
market to be used for burn wounds, and early and reliable
assessment of burn severity is critical for better management of
burn patients. The predictive software DeepView
AI®-Burn seamlessly integrates with our UKCA granted application
for our imaging device, DeepViewSnapShot.® The DeepView System
processes the image and displays the original wound, while
highlighting the nonhealing parts of the burn, defined as deep 2nd
and 3rd degree burns. This diagnostic predictive analysis is
delivered within seconds and aids physicians in making an informed
decision on patient treatment protocols.
UKCA marking is a product certification system
established by the UK government to ensure that products sold in
the UK market (England, Wales, and Scotland) comply with relevant
laws and technical standards. The DeepView AI®-Burn indication is
for individuals aged eighteen years and older. The Company is
looking towards expanding its technology to serve pediatric
populations and is continuing to initiate case studies and case
series with surgeons at leading burn centres.
About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive
AI company focused on medical diagnostics for faster and more
accurate treatment decisions in wound care, with initial
applications involving patients with burns and diabetic foot
ulcers. The Company is working to revolutionize the management of
wound care by “Seeing the Unknown®” with its DeepView® System.
DeepView® is a predictive diagnostic device that offers
clinicians an objective and immediate assessment of a wound’s
healing potential prior to treatment or other medical intervention.
With algorithm-driven results and a goal of substantially exceeding
the current standard of care in the future, DeepView® is
expected to provide faster and more accurate treatment insight
towards value care by improving patient outcomes and reducing
healthcare costs. For more information about DeepView®,
visit www.spectral-ai.com.
Forward Looking
StatementsCertain statements made in this release are
“forward looking statements” within the meaning of the “safe
harbor” provisions of the United States Private Securities
Litigation Reform Act of 1995, including statements regarding the
Company’s strategy, plans, objectives, initiatives and financial
outlook. When used in this press release, the words “estimates,”
“projected,” “expects,” “anticipates,” “forecasts,” “plans,”
“intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,”
“propose” and variations of these words or similar expressions (or
the negative versions of such words or expressions) are intended to
identify forward-looking statements.
These forward-looking statements are not
guarantees of future performance, conditions or results, and
involve a number of known and unknown risks, uncertainties,
assumptions and other important factors, many of which are outside
Company’s control, that could cause actual results or outcomes to
differ materially from those discussed in the forward-looking
statements. As such, readers are cautioned not to place undue
reliance on any forward-looking statements.
Investors should carefully consider the
foregoing factors and the other risks and uncertainties described
in the “Risk Factors” sections of the Company’s filings with the
SEC, including the Registration Statement and the other documents
filed by the Company. These filings identify and address other
important risks and uncertainties that could cause actual events
and results to differ materially from those contained in the
forward-looking statements.
Contacts:
Investors:
The Equity GroupDevin SullivanManaging
Directordsullivan@equityny.com
Conor RodriguezAnalystcrodriguez@equityny.com
Media:Russo PartnersDavid
SchullRusso Partners(858)
717-2310david.schull@russopartnersllc.com
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