Inspire Medical Systems, a company specializing in innovative, minimally invasive solutions for obstructive sleep apnea (OSA), has announced the FDA approval of its Inspire V therapy system. This advanced system includes the next-generation neurostimulator, Bluetooth-enabled patient remote, and physician programmer, marking a significant development in treating moderate to severe OSA. The Inspire V system builds on Inspire's reputation as a leader in neurostimulation technology, being the first and only therapy approved by the FDA, EU MDR, and PDMA for this condition.
The approval of the Inspire V system signifies a crucial milestone for Inspire Medical Systems as it prepares for a full commercial launch in the United States. The company aims for a soft launch in late 2024, with a broader rollout in 2025. The focus remains on ensuring operational readiness, including manufacturing and inventory management, to meet the anticipated demand for this cutting-edge OSA treatment.
