OxyNov receives CE mark for Free O2 and ISO 13485 certification
On May 8, 2017, OxyNov announced that it had reached a major milestone in obtaining a CE mark for its FreeO2 medical device as well as an ISO 13485 certification for quality management of its products and related services.
On the strength of its European certification for the FreeO2, OxyNov will now be taking steps to obtain market approval from the Food and Drug Administration (FDA) in the United States and Health Canada in Canada.
It is worth recalling that the FreeO2 is a medical device used in oxygen therapy that automatically controls oxygen titration and patient weaning based on their condition or specific oxygenation needs. FreeO2 represents a key international innovation in oxygen therapy and targets, in the initial stage, pneumology, cardiology, neurology, pediatrics and emergency medicine in private and public hospitals.
This technology will contribute to the improvement of the quality of life and longevity of patients stricken with pulmonary disease and is in line with the concept of sustainable health, which has become a societal goal.
For additional information, please refer to the press release: