Predictmedix To Launch Infectious Diseases Clinical Trial in North American Hospital for FDA Medical Device Classification of Safe Entry Stations
Predictmedix Inc. (CSE:PMED)(OTCQB:PMEDF) has announced a clinical study set to begin in February 2022 at a North American hospital, aimed at validating its AI-driven Infectious Diseases Detection Solution. The study will utilize the company's Safe Entry Stations to screen staff and incoming patients for infectious diseases, including COVID-19. This step is crucial for FDA Class II medical device certification and commercial launch. Results will be published in a peer-reviewed journal. The study aims to enhance the AI algorithms and data collection, supporting the company's expansion in healthcare.
- Initiation of clinical study for AI technology to detect infectious disease symptoms.
- Expected FDA Class II certification as a crucial step toward commercialization.
- Third-party validation anticipated to support the efficacy and productivity of technology.
- Potential delays in FDA approval process may impact commercialization timeline.
- Dependence on successful study results could pose risks if outcomes are unfavorable.
Independent Study for Infectious Diseases Symptom Detection in a Clinical Setting to Provide Additional Third-Party Validation; Prerequisite Ahead of Planned FDA Certification as Class II Medical Device
TORONTO, ON / ACCESSWIRE / January 26, 2022 / Predictmedix Inc. (CSE:PMED)(OTCQB:PMEDF) ("Predictmedix" or the "Company"), an emerging provider of rapid health screening solutions powered by a proprietary artificial intelligence (AI), today announced a clinical study set to begin in February 2022 with researchers and doctors at a North American hospital to use the Company's patent-pending, proprietary AI technology to detect symptoms of infectious diseases.
Predictmedix 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 COVID-19 positive patients that will then be validated by PCR tests. The Company expects that this hospital study will provide a third-party independent validation of the Company's Infectious Diseases Detection Solution, ahead of a commercial launch and fulfilling a prerequisite for certification by the U.S. Food and Drug Administration (FDA).
The results of the study will be published in a peer-reviewed medical journal. Predictmedix has engaged an accredited consulting firm to assist the Company in seeking classification of the technology as a Class II Medical Device in the United States. Class II devices are FDA approved for the market through the Premarket Notification, or 510(k) process. 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 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 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.
"Usage of our technology in a hospital setting to protect staff and patients while gathering important data is key step as we seek to expand our business into the North American healthcare sector," said Dr. Rahul Kushwah, Interim Chief Executive Officer of Predictmedix. "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.
"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. We look forward to providing additional updates as we work to expand upon our existing markets across North America, India and beyond," concluded Kushwah.
About Predictmedix Inc.
Predictmedix (CSE:PMED)(OTCQB:PMEDF) 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, 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.
Investor Relations Contact
Lucas A. Zimmerman
MZ Group - MZ North America
949-259-4987
PMEDF@mzgroup.us
www.mzgroup.us
Caution Regarding Forward-Looking Information:
THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management's reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances. The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful. Additionally, there are known and unknown risk factors which could cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein, such as, but not limited to dependence on obtaining regulatory approvals; the ability to obtain intellectual property rights related to its technology; limited operating history; general business, economic, competitive, political, regulatory and social uncertainties, and in particular, uncertainties related to COVID-19; risks related to factors beyond the control of the Company, including risks related to COVID-19; risks related to the Company's shares, including price volatility due to events that may or may not be within such party's control; reliance on management; and the emergency of additional competitors in the industry.
All forward-looking information herein is qualified in its entirety by this cautionary statement, and the Company disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except required by law.
Disclaimer: "The Company is not making any express or implied claims that its product has the ability to diagnose, eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time."
SOURCE: Predictmedix
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