Other
Personalized Therapy Comfort Settings (PTCS)
ResMed Corp
FDA
FDA-cleared AI medical device
Machine-learning software, marketed as Smart Comfort, that recommends personalized CPAP comfort settings for adults with obstructive sleep apnea through the myAir app on compatible ResMed therapy devices, drawing on de-identified real-world sleep data and user characteristics to support acclimatization to and adherence with prescribed positive airway pressure therapy.
FDA Submission Metadata
- Submission number
- K251657
- Decision date
- December 2025
- FDA panel
- Anesthesiology
- Product code
- BZD
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA