-- 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, ON / ACCESSWIRE / March 8, 2023 /
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
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Dr. Rahul Kushwah
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