Predictmedix Inc. (CSE:PMED, OTCQB:PMEDF) has announced the completion of a 1,600-person clinical study at a prominent University in Indonesia to validate the company's AI-powered non-invasive screening technology 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, it said 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, it added.
"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 in GDP - the market opportunity for Safe Entry is immense, not only in Indonesia but also throughout the ASEAN region,” Predictmedix chief operating officer Dr Rahul Kushwah said in a statement.
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“There's a strong demand for various medical devices in Indonesia, and the sheer size of the population positions Predictmedix to build a lucrative sales pipeline," Kushwah added. "The further validation of our technology from the University adds even more credibility to Safe Entry and the work we are accomplishing at Predictmedix.”
Predictmedix explained that the National Agency of Drug and Food Control (NADFC) under the Indonesian Ministry of Health (MoH) regulates medical devices. The organization oversees 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 company said the approval process is not expected to take a significant amount of time. The University is expected to begin the certification process within March of 2023, it added.
"The Safe Entry Station powered by artificial intelligence is a highly effective and intelligent instrument for detecting health problems and modernizing medical examinations," commented associate professor Ts (professional technologist) Dr Zulkarnain Kedah.
Professor Dr Ir Untung Rahardja, president of the University of Raharja, added: "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.”
Predictmedix 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, fatigue or various mental illnesses.
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