The expanded clearance allows patients with moderate to severe obstructive sleep apnea using the latest Inspire implants to undergo high-resolution 3.0 Tesla MRI scans under specified conditions.

Key takeaways:

The FDA has approved expanded magnetic resonance imaging (MRI) compatibility for Inspire IV and V systems to include 3.0 Tesla (3T) scanners.
This approval builds on the previous July 2022 clearance for 1.5T full-body MRI scans, allowing patients with the sleep apnea implant access to higher-resolution imaging.
Inspire V, the latest generation of the therapy, was released in May 2025.

The US Food and Drug Administration (FDA) has approved expanded magnetic resonance imaging (MRI) for both the Inspire IV and V systems to include use at 3.0 Tesla (3T).

Under specified conditions, patients implanted with the Inspire IV or Inspire V devices can now undergo high-resolution 3.0T MRI scans. A 3.0T MRI refers to the strength of the scanner’s magnetic field, and these scans produce detailed images of the brain, spine, joints, prostate, and other critical structures. The FDA previously approved expanded, full-body MRI compatibility for 1.5T scans in July 2022.

The Inspire implant is a small device that works inside the body during sleep, delivering gentle pulses with each breath to move the tongue forward and keep the airway open for patients with obstructive sleep apnea (OSA). Inspire V, the latest generation of the therapy, was released in May 2025.

“We are excited to expand access to some of the most advanced imaging technology in modern medicine,” says Tim Herbert, chairman and chief executive officer of Inspire Medical Systems Inc, in a release. “MRI compatibility is an important milestone to achieve. We hope this further strengthens long-term confidence in Inspire therapy for both patients and clinicians.”

“This recent FDA approval to expand MRI imaging capability to 3.0T under specified conditions for Inspire IV and V patients demonstrates our commitment to optimize the patient experience,” says Dr Ruchir P. Patel, vice president and senior medical director, in a release. “We are pleased to know more patients with moderate to severe OSA have an opportunity to access our therapy with less restrictions when undergoing MRI imaging.”

Clinicians and patients can review the “Inspire MRI Guidelines for Inspire Therapy” at manuals.inspiresleep.com for specific imaging conditions at 3.0T.