OxyNov Filed 510(k) Submission for FreeO2 Device
Quebec, Canada-based OxyNov has filed a 510(k) submission to the FDA for its FreeO2 device that automatically adjusts a patient's oxygen flow.
The device is designed to continuously adjust the patient's oxygen for their individual needs to help them remain within the target oxygen saturation set by the clinician.
The system proved superior in clinical studies to manual or constant flow oxygen titration in maintaining the desired oxygen level, the company said, adding that it also minimized the duration of desaturation or severe supersaturation compared to conventional oxygen therapy.
In anticipation of a 510(k) clearance by the FDA in several months, the company is now preparing to launch the product in the U.S. market.
The FreeO2 device previously gained Europe’s CE mark and a license from Health Canada.