Inspire Medical Systems (INSP) FDA Approvals

Inspire Medical Systems' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Inspire Medical Systems (INSP). Over the past two years, Inspire Medical Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Inspire. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Inspire V FDA Regulatory Events

Inspire V is a drug developed by Inspire Medical Systems for the following indication: for patients with obstructive sleep apnea (OSA). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Outcome - October 10,2025

• Drug: Inspire V
• Announced Date: October 10, 2025
• Indication: for patients with obstructive sleep apnea (OSA)

Inspire Medical Systems, Inc. today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company's limited market release in the United States including single site experience at two leading centers.

Inspire Medical Systems, Inc. published clinical outcomes for its new Inspire V system from a Singapore study and a limited U.S. market release at leading centers. In Singapore, 44 patients were followed for six months after implantation. Surgeons cut implant times by 20% compared to the previous model, and all procedures succeeded. Internal respiratory sensing removed the need for external leads, and the device achieved 87% inspiratory phase overlap versus 79% with the older system. Patients averaged 5.5 hours per night on therapy, and their average apnea-hypopnea index dropped from 34 to 8 events per hour. Safety was strong, with only two minor infections.

In the U.S., 101 patients at ten centers completed implants without serious issues. At 60 days, patients used the device 6.8 hours nightly at 1.7 volts. Preliminary sleep studies on 34 patients showed AHI cut from 30 to 4.5 events per hour. Single-site data from Boston and Colorado confirm shorter procedure times and higher surgery volume.

Inspire Medical Systems FDA Events - Frequently Asked Questions

Has Inspire Medical Systems received FDA approval?

As of now, Inspire Medical Systems (INSP) has not received any FDA approvals for its therapy in the last two years.

What drugs has Inspire Medical Systems submitted to the FDA?

In the past two years, Inspire Medical Systems (INSP) has reported FDA regulatory activity for Inspire V.

What is the most recent FDA event for Inspire Medical Systems?

The most recent FDA-related event for Inspire Medical Systems occurred on October 10, 2025, involving Inspire V. The update was categorized as "Outcome," with the company reporting: "Inspire Medical Systems, Inc. today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company's limited market release in the United States including single site experience at two leading centers."

What conditions do Inspire Medical Systems' current drugs treat?

Currently, Inspire Medical Systems has one therapy (Inspire V) targeting the following condition: for patients with obstructive sleep apnea (OSA).