Predictmedix Inc. (CSE:PMED, OTCQB:PMEDF) has announced that a clinical study is set to begin in February 2022 with researchers and doctors at a North American hospital to use its patent-pending, proprietary artificial intelligence (AI) technology to detect symptoms of infectious diseases.
The Toronto-based company said it is providing one Safe Entry Station to be used to screen staff to provide protection, and two units to screen incoming patients as well as collect symptom data from coronavirus (COVID-19) positive patients that will then be validated by PCR tests.
It said it expects that the hospital study will provide third-party independent validation of its Infectious Diseases Detection Solution, ahead of a commercial launch and fulfilling a prerequisite for certification by the US Food and Drug Administration (FDA).
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"Usage of our technology in a hospital setting to protect staff and patients while gathering important data is a key step as we seek to expand our business into the North American healthcare sector," the company’s interim CEO Dr Rahul Kushwah said in a statement.
“The data and results from the study will be crucial for our application as a Class II Medical Device and can additionally be used to fine-tune our AI algorithms, further improving efficacy.”
Predictmedix said the results of the study will be published in a peer-reviewed medical journal. It has also engaged an accredited consulting firm to assist it in obtaining classification of the technology as a Class II Medical Device in the US.
Class II devices are FDA approved for the market through the Premarket Notification, or 510(k) process, the company explained. The 510(k) process entails a complex application to the FDA, which demonstrates that a device is safe and effective by showing that the device is equivalent to another device or a combination of devices taken together that are on the market.
While individual aspects and features of the Safe Entry Station are comparable to FDA class II devices, it said it is important to note that the Safe Entry Station differs from other medical devices that have this functionality in that it assimilates multiple features and combines them with proprietary artificial intelligence-driven decision making. As a result, the Safe Entry Station has a wide range of potential applications in healthcare as well as any situation where groups of people gather and must be screened rapidly.
“With the already strong results from our previous work, we are confident this study will further validate the abilities of our technology in detecting symptoms of infectious diseases - moving us closer to commercialization of this highly promising application as a medical device,” concluded Kushwah.
“We look forward to providing additional updates as we work to expand upon our existing markets across North America, India and beyond.”
Predictmedix is a leading provider of rapid health screening and remote patient care solutions globally. The company's Safe Entry Stations 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, or various mental illnesses.
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