Case Study

NightBalance Lunoa

NightBalance Lunoa is a compact, mask-free treatment for positional obstructive sleep apnea (POSA).

A palm-sized sensor device is worn across the chest and delivers gentle vibrations that prompt patients to change position without disturbing their sleep. A companion mobile app and online portal make treatment progress easy to see; with adherence and positional sleep data accessible via a streaming, cloud-based system.

Person wearing connected wearable device for POSA

Design and development of a connected wearable device for POSA

S3 Connected Health’s expertise in wireless connectivity, software development, SaMD, IoMT, medical device regulations, and data security were sought to support the development of NightBalance Lunoa, an EU CE Class IIa and FDA Class II medical device.

In compliance with 60601 Medical Electrical Equipment and Systems and 62304 Medical Device Software standards, we designed and developed a next-generation sensor device with Bluetooth Low Energy (BLE) connectivity, including electronics (PCBA), firmware, mobile application for iOS and Android, and cloud-based portal.

This project required the multidisciplinary expertise of S3 Connected Health’s hardware engineers, firmware engineers, software engineers, quality assurance engineers, web developers, security experts, and systems analysts.

They quickly and efficiently added secure wireless connectivity into a small, power-constrained medical device and developed a secure mobile app to communicate with the cloud-based portal.


Project Elements


The device has successfully passed through classification in the USA, Europe, and Australasia; it can now be prescribed by physicians to patients with positional OSA.

The mobile app and portal display therapy progress and sleep data, which allows patients and physicians to easily track progress. Adherence with NightBalance is significantly higher than PAP in patients diagnosed with positional OSA.

lunoa-case-study-graphicMore than 70%
of people using NightBalance reported a long-term improvement in the three most common positional OSA symptoms, including:

  • Non-refreshing sleep

  • Fatigue

  • Episodes of breathing cessations, gasping, and/or choking during the night

    *NightBalance OSA Symptoms survey: Reimbursement Dossier Netherlands.
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