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Oxynov Announces 510(K) Submission To U.S. FDA For Its FreeO2™ Device

Thursday, September 29, 2022

OxyNov Inc., a medical device company, has taken a significant step in gaining marketing authorization for its oxygen therapy device, the FreeO2™, in the United States. The company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA), the government agency responsible for ensuring the safety and efficacy of medical devices.

The FDA plays a crucial role in protecting public health by regulating medical products and promoting innovation that enhances their effectiveness, safety, and affordability. By filing the 510(k) submission, OxyNov aims to obtain clearance from the FDA for the commercialization of the FreeO2™ device in the U.S. market.

This submission is an important milestone for OxyNov and demonstrates its commitment to advancing healthcare. Patrice Allibert, PhD, the President and CEO of OxyNov, expressed the significance of this achievement and its implications for the company's customers and patients.

The FDA review process for the 510(k) submission typically takes several months. While waiting for clearance, OxyNov is actively preparing for the launch of the FreeO2™ device in the United States. The company recognizes the importance of establishing a strong reputation among distributors and sees the U.S. market as a key opportunity for growth and success.

Gaining FDA clearance for the FreeO2™ device would open doors for OxyNov to bring its innovative oxygen therapy solution to healthcare providers and patients in the United States. The FreeO2™ device offers advanced features and capabilities that can significantly improve oxygen therapy delivery and enhance patient care.

OxyNov's FreeO2™ device has been designed to address the challenges and limitations associated with traditional oxygen therapy. It utilizes cutting-edge technology to deliver oxygen to patients in a precise and personalized manner. The device incorporates intelligent algorithms and sensors to continuously monitor the patient's oxygen levels and adjust the therapy accordingly.

The FreeO2™ device offers numerous benefits compared to conventional oxygen therapy methods. Its ability to provide precise and tailored oxygen delivery helps optimize treatment outcomes and improve patient comfort. The device's intelligent algorithms enable real-time adjustments based on the patient's condition, ensuring that the right amount of oxygen is delivered at the right time.

Moreover, the FreeO2™ device supports healthcare professionals in making informed decisions by providing comprehensive data and analytics. It records and analyzes oxygen saturation levels, respiratory rate, and other relevant parameters, allowing clinicians to monitor patients' progress and adjust treatment plans as needed.

By streamlining the oxygen therapy process and enhancing its effectiveness, the FreeO2™ device has the potential to improve patient outcomes and quality of life. It empowers healthcare providers with a powerful tool to optimize oxygen therapy and deliver personalized care to patients with various respiratory conditions.

OxyNov is dedicated to advancing the field of healthcare and bringing innovative solutions to the market. The company's commitment to research and development has led to the creation of the FreeO2™ device, which has garnered attention and recognition for its potential to revolutionize oxygen therapy.

The success of OxyNov's 510(k) submission and subsequent FDA clearance would be a significant achievement for the company. It would pave the way for the commercialization of the FreeO2™ device in the United States, opening new opportunities for growth and expansion.

In conclusion, OxyNov's filing of a 510(k) submission for the FreeO2™ device with the FDA represents a crucial step towards obtaining marketing authorization in the United States. This milestone demonstrates the company's commitment to advancing healthcare and delivering innovative solutions to improve patient care. The FreeO2™ device's potential to optimize oxygen therapy and enhance patient outcomes positions OxyNov for success in the U.S. market and establishes its reputation among distributors and healthcare providers.

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