Predictmedix Announces
Completion of 1600-Person Clinical Study for Safe Entry's Medical
Device Regulatory Approval in Indonesia
-
The
1600-person study at a prestigious University in Jakarta, Indonesia
prepares Predictmedix's Safe Entry for regulatory approval listed
as a 'Medical Device'
-
Medical device
classification allows Predictmedix to commercialize Safe Entry at
scale in Indonesia
-
Third-party clinical validation yet another milestone for
Predictmedix's AI-Powered screening technology
Toronto, Ontario,
March 8, 2023 -- InvestorsHub NewsWire -- Predictmedix Inc.
("Predictmedix" or the "Company") (CSE: PMED) (OTCQB: PMEDF) (FRA:3QP), an emerging provider of rapid
health screening solutions powered by a proprietary artificial
intelligence (AI), today announced the completion of a 1600-person
clinical study taken place at a prominent University in Indonesia
for the purpose of validating the company's AI-powered non-invasive
screening technology in order to prepare for the regulatory
approval application to classify Safe Entry as a medical
device.
As the company's
commercialization efforts are underway in Indonesia, having Safe
Entry classified as a Medical Device is an integral step to scaling
into the landscape of the Indonesian market. The third-party
validation of the company's AI-powered screening technology marks
yet another milestone for the efficacy of Safe Entry.
The National Agency of
Drug and Food Control (NADFC) under the Indonesian Ministry of
Health (MoH) regulates medical devices. The organization overseas
all pre-market and post-market evaluation, standardization,
legislation, and Good Manufacturing Practices (GMP) certification.
All Medical Devices and IVDs (In Vitro Diagnostics) must receive a
registration number and product license issued by the Ministry of
Health to a local licensed distributor before import. Due to the
non-invasive nature of Predictmedix's Safe Entry unit, the approval
process is not expected to take a significant amount of time. The
University is expected to begin the certification process within
the month of March of 2023.
"The Safe Entry
Station powered by artificial intelligence is a highly effective
and intelligent instrument for detecting health problems and
modernizing medical examinations," commented Assoc. Prof. Ts. Dr.
Zulkarnain Kedah.
"AI powered screening
in a quick, non-invasive, no contact methodology is the way of the
future. The Safe Entry Unit has been validated by our University
with demonstrated high accuracy rates for multi functional
application. We look forward to getting this approved as a medical
device for Indonesia and assisting with commercial deployment",
commented Professor Dr. Ir. Untung Rahardja, M.T.I., MM, President
at the University of Raharja.
"With Indonesia being
the fourth most populous country in the world housing over 280
million people and being a part of the
ASEAN group of countries with over 680 million people and more than
10 trillion dollars in GDP - the market opportunity for Safe
Entry is immense, not only in Indonensia but also throughout the
Asean region. There's a strong demand for various medical devices
in Indoensia, and the sheer size of the population positions
Predictmedix to build a lucrative sales pipeline," commented Dr.
Rahul Kushwah, Chief Operating Officer at Predictmedix. "The
further validation of our technology from the University adds even
more credibility to Safe Entry and the work we are accomplishing at
Predictmedix."
About Predictmedix
Inc.
Predictmedix (CSE:
PMED) (OTCQB: PMEDF) (FRA:3QP) is an emerging provider of rapid
health screening and remote patient care solutions globally. The
Company's Safe Entry Stations – powered by a proprietary artificial
intelligence (AI) – use multispectral cameras to analyze
physiological data patterns and predict a variety of health issues
including infectious diseases such as COVID-19, impairment by drugs
or alcohol, fatique or various mental illnesses. Predictmedix's
proprietary remote patient care platform empowers medical
professionals with a suite of AI-powered tools to improve patient
health outcomes. To learn more, please visit our website at
www.Predictmedix.com or follow us on Twitter, Instagram or
LinkedIn.
Public Relations
Contact
For further media
information or to set up an interview, please contact:
Nelson
Hudes
Hudes Communications
International
(905) 660
9155
Nelson@hudescommunications.com
Dr. Rahul
Kushwah
(647) 889
6916
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