Rhythm Express - RX-1 Sleep is a Software as a Medical Device (SaMD) that measures the apnea–hypopnea index (AHI), sleep/wake, posture and respiratory effort. RX-1 Sleep is indicated for patients suspected of having sleep apnea. RX-1 Sleep employs two cloud-based static/locked AI deep learning models for AHI and for sleep/wake that receive inputs from two FDA-cleared devices used in the clinical and home environment: a) the Rhythm Express RX-1 mini Remote Cardiac Monitoring System (RCMS) (K241179), and b) a Viatom pulse oximeter (K191088). Additionally, RX-1 Sleep includes two non-AI device software functions (DSFs) that rely on inputs from the RX-1 mini and use traditional signal processing techniques for respiratory effort estimation and posture detection during sleep. These non-AI-DSFs do not interact with the AI-DSFs. The RX-1 mini is worn on the chest and communicates ECG and heart rhythm information, as well as actigraphy from an on-board triaxial accelerometer to the RS-1 cloud-based server via a cellular or Wi-Fi connection. The pulse oximeter is worn as indicated and records functional oxygen saturation of arterial hemoglobin (SpO2) while the patient is asleep. Pulse oximetry data are communicated to the RX-1 mini via a secure Bluetooth link for upload of SpO2 data to the RS-1 server and all data are synchronized. RX-1 Sleep resides on the RS-1 Server and outputs a consolidated sleep report, accessible via the RX-1 mini Clinic Portal. The Operator Portal presents RX-1 Sleep outputs and full disclosure signals for review by a qualified healthcare professional.
2026-10-01