DIAGNOS Successfully Completes ISO 13485 / MDSAP Audit and receives its certification to move forward with FDA and Health Canada
August 20 2024 - 8:45AM
Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK)
(OTCQB: DGNOF) a leader in early detection of critical health
issues through the use of its FLAIRE platform based on Artificial
Intelligence (AI), announces today that its quality management
system fully complies with ISO 13485 standard and applicable
regulatory requirements for medical devices.
As part of the requirements for the
commercialization of our flagship product CARA, DIAGNOS must
undergo thorough statutory quality compliance audits
under the Medical Device Single Audit Program (MDSAP). MDSAP is a
comprehensive approach to quality management systems auditing among
countries devoted to enhance the safety of medical devices.
“I would like to take this opportunity to thank
our employees for their hard work in this important process. Our
clients expect our healthcare solutions to perform in compliance
with the highest quality standards and DIAGNOS is able to meet
their expectations. Without this certification we are not allowed
to sell our solutions worldwide. This new certification also covers
all new AI based regulatory requirements that have been approved by
multiple governments including: Canada, USA and European
countries,” said Mr. Yves-Stephane Couture, Chief Operating
Officer of DIAGNOS.
“This huge achievement from our team comes at a
time where Artificial Intelligence is growing and we want to be the
leader in our field. DIAGNOS has reached an inflection point in its
sales growth going from a one test company for diabetics to a
company providing a suite of tests thereby accelerating
profitability and patient satisfaction. A report from Precedence
Research said that the global artificial intelligence (AI) in the
healthcare Market size, which was USD 19.27 billion in 2023 is
estimated at 26.69 billion in 2024 and is anticipated to reach
around USD 613.81 billion by 2034, expanding at a CAGR of 36.83%
from 2024 to 2034,” said Mr.
André Larente,
President of DIAGNOS.
DIAGNOS is currently in the process of obtaining
regulatory licences in Canada (Health Canada) and in the USA
(US-FDA) for four additional modules to assist health care
professionals in identifying generally abnormal through Optical
Coherence Tomography retinal images and in the grading of Fundus
images to detect signs of Retinopathy for general public adult,
Age-Related Macular Degeneration, Diabetic Retinopathy and
Hypertensive Retinopathy. DIAGNOS is also working on additional
diseases through the use of the retina imaging. More information
about these modules can be found in the April 16, 2024 press
release on the subject.
About DIAGNOS DIAGNOS is a publicly traded
Canadian corporation dedicated to early detection of critical
health problems based on its FLAIRE Artificial Intelligence (AI)
platform. FLAIRE allows for quick modifying and developing of
applications such as CARA (Computer Assisted Retina Analysis).
CARA’s image enhancement algorithms provide sharper, clearer and
easier-to-analyze retinal images. CARA is a cost-effective tool for
real-time screening of large volumes of patients.
Additional information is available
at www.diagnos.ca and www.sedarplus.com.
This press release contains forward-looking
information. We cannot guarantee that the forward-looking
information mentioned will prove to be accurate, as there may be a
significant discrepancy between actual results or future events and
those mentioned in this statement. DIAGNOS disclaims any intention
or obligation to publicly update or revise any forward-looking
information, whether as a result of new information, future events
or otherwise. The forward-looking information contained in this
press release is expressly covered by this caution.
Neither the TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
For further information, please contact:
Mr. André Larente, President
DIAGNOS Inc.
Tel: 450-678-8882 ext. 224
alarente@diagnos.ca
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