DIAGNOS Successfully Completes ISO 13485 / MDSAP Audit
January 21 2021 - 10:01AM
Diagnos Inc. (“DIAGNOS”, the “Corporation” or ”we”) (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 continues to comply with the applicable regulatory
requirements for medical devices.
As part of the
requirements for the commercialization of our flagship product CARA
from Health Canada and the Food and Drug Agency in the US (FDA),
DIAGNOS must undergo thorough statutory annual 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 each of our employees for their hard work
and commitment to the quality of our products. Our clients expect
our healthcare solutions to perform in compliance with the highest
quality standards, while being safe, and DIAGNOS is able to meet
their expectations”, said Mr. André Larente, President of
DIAGNOS.
About DIAGNOSDIAGNOS is a publicly-traded
Canadian corporation with a mission of early detection of critical
health issues through the use of its Artificial Intelligence (“AI”)
tool CARA (Computer Assisted Retina Analysis). CARA is a
tele-ophthalmology platform that integrates with existing equipment
(hardware and software) and processes at the point of care. CARA’s
Artificial Intelligence image enhancement algorithms make standard
retinal images sharper, clearer and easier to read. CARA is
accessible securely over the internet, and is compatible with all
recognized image formats and brands of fundus cameras, and is EMR
compatible. CARA is a cost-effective tool for screening large
numbers of patients in real-time. CARA complies with local
regulations, is FDA cleared for commercialization in the United
States of America, is Health Canada licensed for commercialization
in Canada, licensed by the Saudi FDA, COFEPRIS in Mexico and is CE
marking compliant in Europe.
Additional information is available at www.diagnos.com and
www.sedar.com.
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.
This news release may contain forward-looking
information. There can be no assurance that forward-looking
information will prove to be accurate, as actual results and future
events could differ materially from those anticipated in these
statements. DIAGNOS disclaims any intention or obligation to
publically 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 news release is
expressly qualified by this cautionary statement.
For further information, please contact:
Mr. André Larente, PresidentDIAGNOS Inc.Tel:
450-678-8882 ext. 224alarente@diagnos.ca
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