Bairitone Health Receives FDA Breakthrough Device Designation For Sleep Apnea Technology

Bairitone Health received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Somnar technology platform, which is under development for the assessment of obstructive sleep apnea (OSA). The platform is not yet commercially available.

The Somnar system includes a facial patch that uses passive sonar technology during sleep to measure airway vibrations and assess airway behavior across sleep stages and positions. The data is intended to help identify underlying causes of OSA and inform treatment selection.

OSA affects millions of people and is associated with cardiovascular, metabolic, and neurocognitive complications. The condition is widely considered underdiagnosed and . . .