Nov 28, 2022, 05:00 ET
BALTIMORE, Nov. 28, 2022 /PRNewswire/ — Opteev Technologies, Inc. today announced it has developed an affordable breath analyzer, ViraWarn, that detects COVID-19, Influenza, and RSV in less than 60 seconds. The device, which is multiple-use and rechargeable, has been submitted to the FDA for review as a new easy-to-use and convenient way to self-test for COVID-19 and other respiratory illnesses.
The submission to the FDA was based on early data from on-going clinical trials. ViraWarn uses a silk-based biosensor that attracts the electrical discharge of respiratory viruses coupled with an artificial intelligence processor to filter out any potential inaccuracies. Extremely user-friendly, users simply turn it on, blow twice into the mouthpiece, and an LED notification light will indicate a positive or negative result in under 60 seconds. ViraWarn is reusable and comes with multiple biosensor replacement cartridges that only require being replaced after a positive result or after a period of 2 – 3 weeks of daily usage.
ViraWarn was submitted to the U.S. Food and Drug Administration (FDA) for Pre-Emergency Use Authorization (Pre-EUA), which is the first recommended step towards FDA recognition. The Pre-EUA process allows FDA scientific and technical subject experts to begin a review of information to assist in the development of conditions of authorization and other documentation needed for submission of a formal EUA and helps to facilitate complete EUA requests.
“We’re extremely enthusiastic about the development of the world’s first affordable breath analyzer that can rapidly detect COVID-19, RSV, and Influenza in exhaled breath sample,” said Conrad Bessemer, President and Co-Founder of Opteev. “ViraWarn is designed to allow users an ultra-fast and convenient way to know if they are spreading a dangerous respiratory virus. With a continued increase in COVID-19 and a new surge in RSV and Influenza cases, we’re eager to bring ViraWarn to market so consumers can easily blow into a personal device and instantly find out if they are positive or negative. Opteev is looking forward to working with the FDA on this interactive review so that we can get ViraWarn to the public in a timely, expedient manner.”
Disclaimer: The statements made regarding these products have not been evaluated by the Food and Drug Administration. This press release is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please check with your doctor. The news site hosting this press release is not associated with Opteev Technologies, Inc. It is merely publishing a press release announcement submitted by a company, without any stated or implied endorsement of the product or service.
Opteev Technologies, Inc, is a Baltimore, MD-based technology company that is revolutionizing self-diagnostics through its novel viral detection technology. Established in 2020, Opteev is a subsidiary company of Novatec, Inc., a 50-year-old manufacturer, and supplier of machinery and sensor technology, and employs over 200 individuals in Maryland, including engineers, virologists, and other clinical staff, and partners with testing laboratories and hospitals in New Jersey and in India to conduct ongoing clinical trials for its new and developing self-diagnostic devices like ViraWarn.
SOURCE Opteev Technologies, Inc.; https://www.prnewswire.com/news-releases/pocket-sized-breath-analyzer-detects-covid-19-rsv-influenza-in-under-60-seconds-301687394.html
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