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PNOĒ is preparing to launch the PNOĒ 2.0 device on October 1, a breath-analysis mask that users can operate themselves in gyms without a trained operator. The device measures 23 vital metrics, but it is not approved by the Food and Drug Administration and does not provide medical recommendations.
The Centers for Medicare and Medicaid Services is expanding the ACCESS program to include heart failure, chronic obstructive pulmonary disease, substance use disorders, and smoking cessation, while extending support for certain musculoskeletal conditions. The program combines outcome-linked payments with a regulatory pathway for collecting real-world data on certain digital health technologies.