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Inogen achieves regulatory milestones to support portable oxygen products
The Fly

Inogen achieves regulatory milestones to support portable oxygen products

Inogen announced that it has achieved regulatory milestones in the EU and the US to support its portable oxygen concentrator products. Inogen received European Medical Device Regulation certification from its Notified Body, the British Standards Institution , BSI, in December 2022, granting permission to sell and commercialize Inogen One G4 and the updated version of its Inogen One G5 portable oxygen concentrators in the EU. Additionally on December 9 , Inogen was granted clearance for its 510k premarket notification by U.S. Food and Drug Administration FDA for a new portable oxygen concentrator, Rove 4, which will take Inogen’s leadership in portability of POCs to the next level. These regulatory achievements enhance Inogen’s portfolio of portable oxygen concentrator products with the addition of the Rove series. Rove 6, a new and improved 6-setting device has already been launched in European countries where reimbursement is grandfathered, and Rove 4, a 4-setting device delivering ultimate performance and portability, is expected to launch in the US by the back half of 2023 having received FDA market clearance in December. "We are pleased to announce the receipt of both the EU MDR certification and US FDA clearance," said Nabil Shabshab, President and Chief Executive Officer. "This is an important next step in Inogen cementing its commitment to continue leading POC innovations to serve patients in need of oxygen therapy around the world. The Rove series will serve as our next generation POC platform with product launches being planned for 2023. We are excited about these new products and the progress in the overall innovation roadmap towards next generation offerings to serve COPD patients and beyond."

Published first on TheFly

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