Bairitone Health’s platform uses passive sleep sonar and a facial patch to map airway anatomy during natural sleep, aiming to pinpoint the root causes of obstruction and guide personalized therapy.
Key takeaways:
- Bairitone Health received FDA Breakthrough Device Designation for its noninvasive technology designed for obstructive sleep apnea.
- The platform utilizes a facial patch to map airway vibrations to anatomy.
- The technology aims to provide clinicians with accessible tools to make informed care decisions and create clearer pathways for patients who do not benefit from standard therapies.
Bairitone Health has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its sleep sonar for anatomic polysomnography technology to pinpoint the root cause of airway obstruction in people with obstructive sleep apnea (OSA).
The FDA grants Breakthrough Device Designation to technologies that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions and that address a significant unmet need. The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.
According to Bairitone, this designation underscores several important unmet needs in OSA care:
- Too many patients still do not get the insight needed to guide the right treatment
- Clinicians need more accessible, less invasive tools to support better care decisions
- Patients who cannot tolerate or do not benefit from standard therapies need clearer pathways forward
“At Bairitone, we’re honored to receive FDA Breakthrough Device Designation for our noninvasive diagnostic technology in obstructive sleep apnea. We see this as recognition of the significant unmet need in OSA care and the importance of tools that can help support more informed treatment decisions. Our goal is to bring more precise anatomical insight to sleep apnea care in a way that is less invasive, more accessible, and more practical for patients and clinicians,” says Meagan Pitcher, PhD, CEO and co-founder of Bairitone Health.
Bairitone’s platform maps patient anatomy during natural sleep, pinpointing the root cause of airway obstruction. Its passive sleep sonar maps airway vibrations to anatomy utilizing a facial patch, without the need for an MRI, X-ray, or ultrasound.
The technology features dynamic airway mapping to pinpoint obstruction causes by tracking airway behavior across sleep stages, positions, and other metrics. This precision therapy guidance is designed to match effective therapies to each patient by identifying root issues.
Specific capabilities of the platform include the ability to profile multi-level obstruction, reveal primary versus secondary collapse, detect flow-limiting sites, phenotype and select patients, optimize therapy titration, and explain unexpected outcomes.
It is currently for investigational use only, pending FDA clearance.
