DIAGNOS Successfully Completes ISO 13485 / MDSAP Surveillance Audit
January 14 2020 - 9:30AM
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 fully 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, the Food and Drug Agency in the US (FDA) and CE
in Europe, DIAGNOS must undergo thorough statutory annual
quality compliance audits, such as the Medical Device Single Audit
Program (MDSAP). The MDSAP is a comprehensive approach to quality
management systems auditing and includes the development of an
international coalition of countries devoted to pooling resources,
technology, and services to enhance the safety and oversight of
medical devices worldwide.
“I would like to take
this opportunity to personally 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 well while being
safe and DIAGNOS is able to meet their expectations”, said Mr.
André Larente, President of DIAGNOS.
DIAGNOS is also
announcing that Dr. Jean-François Yale has accepted a new role as
scientific advisor to the Corporation and, effective today, Dr.
Yale is no longer a member of the board of directors of the
Corporation.
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 and is CE marking compliant in Europe.
Additional information is available at
www.diagnos.ca and www.sedar.com
This news release contains 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.
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
Diagnos (TSXV:ADK)
Historical Stock Chart
From Aug 2024 to Sep 2024
Diagnos (TSXV:ADK)
Historical Stock Chart
From Sep 2023 to Sep 2024