Inogen Secures Major Regulatory Approvals Across Two Key Markets

Medical device innovator Inogen has successfully navigated regulatory frameworks in both Europe and the United States, earning the necessary certifications to expand its portfolio of portable oxygen concentrator offerings. The company’s expanded product pipeline reflects a strategic commitment to advancing respiratory care technology.

European Approval Paves Way for Market Expansion

In December 2022, the British Standards Institution (BSI), serving as the Notified Body, granted Inogen European Medical Device Regulation (EU MDR) certification. This authorization enables the commercialization of the Inogen One G4 and the refreshed Inogen One G5 lines throughout EU markets. The Rove 6, featuring advanced 6-setting functionality, has already begun distribution in select European territories with established reimbursement pathways.

US Market Clearance Drives Next Generation Launch

Following its EU success, Inogen received FDA 510(k) premarket clearance on December 9, 2022, for its Rove 4 model—a 4-setting portable oxygen concentrator engineered for enhanced performance and mobility. The company projects a US market introduction during the latter half of 2023, representing a significant step forward in portable oxygen concentrator innovation.

Product Differentiation and Market Strategy

The newly approved Rove series establishes the next generation of Inogen’s portable oxygen concentrator platform. The Rove 4 emphasizes portability without compromising therapeutic capability, while the earlier-launched Rove 6 delivers advanced clinical features for markets with grandfathered reimbursement status. Together, these offerings address diverse patient needs across global healthcare systems.

According to Nabil Shabshab, President and Chief Executive Officer: “These regulatory victories reinforce Inogen’s leadership position in portable oxygen concentrator development. The Rove series represents our commitment to delivering next-generation respiratory solutions for COPD patients and other chronic respiratory conditions globally.”

Strategic Outlook

The dual regulatory achievements position Inogen to capitalize on growing demand for home-based oxygen therapy solutions. With products now cleared for deployment across major markets, the company’s innovation roadmap continues advancing toward enhanced offerings that extend patient mobility while managing chronic respiratory disease.

For additional information on Inogen’s respiratory care solutions, visit www.inogen.com

Forward-Looking Statement Notice

This announcement contains forward-looking statements regarding product launches, market expansion, and innovation initiatives. Actual results may differ materially due to regulatory uncertainties, supply chain constraints, component availability, reimbursement policy changes, competitive pressures, and other factors detailed in company SEC filings.