The FDA has approved the next-generation Inspire V therapy system for the treatment of moderate to severe obstructive sleep apnea.
RT’s Three Key Takeaways
- FDA Approval: Inspire Medical Systems Inc has received FDA approval for its next-generation Inspire V therapy system.
- Advanced Features: The new system includes an updated neurostimulator and Bluetooth-enabled patient remote and physician programmer.
- Launch Plans: Inspire is preparing for a soft launch in late 2024 and a full commercial launch in 2025 in the United States.
Inspire Medical Systems Inc, a medical technology company focused on developing minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced it has received US Food and Drug Administration (FDA) approval for the Inspire V therapy system.
The Inspire V therapy system includes the next-generation neurostimulator and the associated Bluetooth patient remote and physician programmer.
“We are thrilled to announce the FDA approval of our next-generation Inspire neurostimulation system,” says Tim Herbert, chairman and chief executive officer of Inspire Medical Systems, in a release. “The FDA approval marks a key milestone for the future of Inspire therapy and reinforces the many years of hard work by our team members.”
Inspire emphasizes in a release that its focus remains on operational readiness, which includes product manufacturing and establishing inventory levels to support a full commercial launch in the United States. The company continues to target a soft launch in late 2024 and a full launch in 2025.
Inspire’s Inspire therapy is FDA, EU MDR, and PDMA-approved neurostimulation technology for the treatment of moderate to severe obstructive sleep apnea.
Photo credit: Inspire Medical Systems
