Spectral AI’s DeepView SnapShot® Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification
19 Ottobre 2023 - 2:00PM
Spectral AI, Inc. (Nasdaq: 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 that its
DeepView SnapShot® Wound Imaging System
(DeepView SnapShot®) is now UK Conformity Assessed
(UKCA)-marked for use in the United Kingdom and has received Class
1 medical device classification with the United States Food and
Drug Administration (FDA).
“We are thrilled to announce the UKCA marking
and Class 1 medical device classification from the FDA for our
DeepView SnapShot® Wound Imaging System. Spectral AI's
commitment to advancing medical diagnostics in tissue health is
reflected in these important milestones,” said Wensheng Fan, CEO of
Spectral AI. “We are confident that our unique AI-driven imaging
platform will empower healthcare professionals in making critical
decisions around the world, and these regulatory developments are
significant steps towards achieving that goal.”
UKCA marking is a product certification system
launched by the UK government to ensure that products sold in the
UK market (England, Wales, and Scotland) comply with the relevant
technical standards and requirements. Following this marking, the
Company has designated six DeepView SnapShot® devices to be
used for evaluation by healthcare professionals in the UK.
Furthermore, the DeepView SnapShot® device obtained Class 1
medical device classification from the FDA. The FDA employs a
comprehensive classification system to rigorously ensure the safety
and effectiveness of medical devices. Within this framework, Class
1 medical devices are specifically categorized for their minimal
risk potential to patients and operators.
Now that the Company has received classification
for the DeepView SnapShot® imaging device, Spectral AI will
seek the regulatory approval for its DeepView AI® - Burn software
to commercialize the complete DeepView SnapShot® System in the
United States and across the globe.
“The unpredictability of severe burn injuries is
a growing and critical problem around the world. We believe that
Spectral AI’s DeepView® platform will allow healthcare providers to
make more accurate, timely and informed decisions regarding the
treatment of these wounds,” said Niko Pagoulatos, Chief Operating
Officer of Spectral AI. “We are very pleased with these important
incremental regulatory developments in the UK and the US as part of
our ongoing efforts to commercialize the DeepView® platform.”
Spectral AI's DeepView SnapShot® is a
patented, universal imaging platform that can house multiple
clinical indications and predictive AI software to assist
clinicians to make faster, accurate decisions in wound care.
DeepView® integrates optical technology and AI-enabled algorithms
using a proprietary database of 263 billion clinically validated
data points to see deep below the skin's surface and distinguish
between healthy and damaged tissue.
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:
Spectral AIChristine Marks VP Marketing and
Commercialization ir@spectral-ai.com
The Equity GroupDevin SullivanManaging
Directordsullivan@equityny.com
Conor RodriguezAnalystcrodriguez@equityny.com
Media:Russo PartnersDavid
SchullRusso Partners(858)
717-2310david.schull@russopartnersllc.com
Guillermo Ruiz, M.D., Ph.D.Russo Partners(646)
218-4604guillermo.ruiz@russopartnersllc.com
Grafico Azioni Spectral AI (NASDAQ:MDAI)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Spectral AI (NASDAQ:MDAI)
Storico
Da Set 2023 a Set 2024