{kanada_flagge}Following the successful completion of a 1600-person study at a prestigious university in Jakarta, Indonesia, Predictmedix Inc (CSE: PMED; OTCQB: PMEDF; FRA:3QP) is preparing for regulatory approval of its AI-powered non-invasive health screening technology as a medical device. The classification as a medical device would enable the Safe Entry solution to be widely commercialized in Indonesia. The clinical validation by independent third parties is another milestone for Predictmedix’s AI-assisted screening technology.
Summary: Indonesia is the fourth most populous country in the world with over 280 million people and is part of the ASEAN group of countries with over 680 million people and a GDP of more than $10 trillion. The market opportunities for Safe Entry are therefore immense, not only in Indonesia but also in the entire ASEAN region. Indonesia could become a first mover in the use of disruptive technologies such as non-invasive diagnostics.
{kanada_flagge}Following the successful completion of a 1600-person study at a prestigious university in Jakarta, Indonesia, Predictmedix Inc (CSE: PMED; OTCQB: PMEDF; FRA:3QP) is preparing for regulatory approval of its AI-powered non-invasive health screening technology as a medical device. The classification as a medical device would enable the Safe Entry solution to be widely commercialized in Indonesia. The clinical validation by independent third parties is another milestone for Predictmedix’s AI-assisted screening technology.
Predictmedix will submit the regulatory application for Safe Entry’s classification as a medical device to the National Agency of Drug and Food Control (NADFC), which is under the Indonesian Ministry of Health. The organization is responsible for all pre-market and post-market assessments, standardization, legislation and Good Manufacturing Practice (GMP) certification. All medical devices and IVDs (in vitro diagnostics) must obtain a registration number and product license prior to importation, which is issued by the Ministry of Health to a licensed local distributor. Due to the non-invasive nature of Predictmedix’s safe entry unit, the registration process is not expected to take much time. It is expected that the university will begin the certification process in March 2023.
Dr. Rahul Kushwah, Chief Operating Officer at Predictmedix stated, “The University’s further endorsement of our technology adds even more credibility to Safe Entry and our work at Predictmedix.”
Professor Dr. Ir. Untung Rahardja, M.T.I., MM, President of the University of Raharja commented, “AI-assisted screening in a rapid, non-invasive and non-contact method is the way of the future. The Safe Entry Unit has been validated by our university and has proven high accuracy rates in multifunctional applications. We look forward to receiving approval as a medical device in Indonesia and supporting its commercial launch.”
Summary: Indonesia is the fourth most populous country in the world with over 280 million people and is part of the ASEAN group of countries with over 680 million people and a GDP of more than $10 trillion. The market opportunities for Safe Entry are therefore immense, not only in Indonesia but also in the entire ASEAN region. Indonesia could become a first mover in the use of disruptive technologies such as non-invasive diagnostics.
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