Rhythm Express Launches RX-1 Sleep Software

The FDA-cleared cloud algorithm pairs sleep-apnea screening with atrial fibrillation monitoring in one at-home system.

Updated on Nov. 6, 2026 in Sleep Disorders

Isometric editorial illustration of two plain matte medical devices, a small cardiac monitor and a fingertip oximeter, resting on a nightstand in a quiet bedroom. — Rhythm Express has launched RX-1 Sleep, an FDA-cleared cloud algorithm pairing sleep-apnea screening with atrial fibrillation monitoring in one at-home system. AI Illustration. Upload story photo >

Rhythm Express has launched RX-1 Sleep, a cloud-based algorithm cleared under an FDA 510(k) to aid evaluation of sleep-related breathing disorders in adults. The software analyzes data from the RX-1 mini cardiac monitor and a Viatom pulse oximeter.

Why it matters

Atrial fibrillation and obstructive sleep apnea frequently coexist but have traditionally been evaluated through separate clinical pathways. Clinicians increasingly treat obstructive sleep apnea as a key modifiable risk factor in managing atrial fibrillation burden.

The software's performance rests on a multicenter validation of 476 polysomnography assessments, the standard sleep lab test, while the combined system tracks cardiac arrhythmias for up to 30 days and breathing disturbances for up to 3 days. The source does not report outcome data showing whether the system improves patient results.

The players

Rhythm Express

Rhythm Express is the company that developed and launched the RX-1 Sleep software and the RX-1 mini cardiac monitoring system.

U.S. Food and Drug Administration

The FDA is the federal agency that reviews and clears medical devices and software for sale in the United States, and it granted the 510(k) clearance for RX-1 Sleep.

The details

RX-1 Sleep generates apnea-hypopnea index, sleep/wake status, respiratory effort, and body position measurements from data captured at home. The combined system is designed to let clinicians assess cardiac rhythm and sleep-disordered breathing in a single compact monitoring approach.

November 6, 2026: Rhythm Express's RX-1 Sleep launch article was published.

Health Landscape

The FDA 510(k) clearance of RX-1 Sleep places a combined atrial fibrillation and sleep-apnea monitoring tool within the regulatory pathway used for cleared monitoring devices. The launch reflects a broader shift toward bundling cardiac and sleep testing that were historically evaluated through separate clinical pathways.

For people with atrial fibrillation who also have suspected sleep apnea, the compact at-home monitoring approach may reduce the need for separate testing arrangements. Patients should still discuss any sleep or heart symptoms with a clinician, since the device's clinical role is to aid evaluation rather than replace diagnosis.

The takeaway

Combined monitoring of heart rhythm and breathing during sleep may simplify care for people whose two conditions often occur together. Anyone with symptoms like loud snoring, daytime fatigue, or irregular heartbeat should raise them with a doctor for proper evaluation.