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FDA-Cleared Wearable Device Redefines Sleep Apnea Monitoring with Promising Clinical Data

Apnimed's pulse oximeter and pending software platform show potential to revolutionize OSA care by enabling multi-night home monitoring and shared decision-making.

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Overview

  • Clinical trials presented at ATS 2025 highlight robust patient adherence, with 85% exceeding recommended usage and one patient wearing the device for 44 days.
  • The device uses advanced transmittance-based photoplethysmography for accurate oxygenation monitoring, even in low perfusion states.
  • Researchers suggest multi-night monitoring with fewer data channels could rival traditional in-lab polysomnography for assessing OSA treatment response.
  • The wearable connects to a smartphone app, allowing patients and providers to share data and collaborate on treatment plans.
  • While the pulse oximeter is FDA-cleared, the connected software platform requires regulatory approval before broader clinical deployment.