QUEBEC CITY, Sept. 28, 2022 /PRNewswire/ - OxyNov Inc. has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA) for the FreeO2™ device, an oxygen therapy device developed by the company itself.
The FDA is a U.S. government agency responsible for protecting the public health by ensuring the safety, efficacy, and security of medical devices, among other things. FDA is also responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.
This 510(k) submission by OxyNov is an important step in obtaining marketing authorization in the United States for the FreeO2™ device.
"Today marks an important milestone in our commitment to our customers and patients to advance the world of healthcare," said Patrice Allibert, PhD, President and CEO of OxyNov.
The application is currently under review by the FDA, and the process is expected to take several months. While waiting for FDA clearance, OxyNov is continuing its preparations for the launch of the FreeO2™ device in the United States.
The commercialization of the FreeO2™ device in the U.S. market will help establish OxyNov's reputation among distributors.
In 2009, two physician-researchers joined forces after a clinical research project to develop a device to automate the administration of oxygen therapy. They founded OxyNov Inc. to focus entirely on developing the FreeO2™ device and improving the application of this treatment on a daily basis. The company has been in business in Europe since 2017 and in Canada since 2019.
The FreeO2™ is a revolutionary oxygen therapy device. It was developed by physician-researchers at Laval University and licensed by Health Canada in 2019. It continuously and automatically adjusts each patient's oxygen flow, accounting for individual needs and dynamics to help patients remain within the target oxygen saturation (SpO2) set by the clinician. The results of various published studies suggest that the FreeO2 device is statistically superior in maintaining normoxia compared to manual or constant flow oxygen titration. Equally important, the FreeO2 device minimizes the duration of desaturation or severe supersaturation compared to conventional oxygen therapy; in all studies, there was a statistically significant difference in favour of the FreeO2 device.
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