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# ‘Breakthrough’ Status for Enhanced Pulse Oximeter
- URL: https://www.fdaweb.com/breakthrough-status-for-enhanced-pulse-oximeter/
- Published: 2019-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:51:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145379

FDA has granted Breakthrough Device status to Med-botics for its Oxalert EPO (Enhanced Pulse Oximeter) device. The wrist-worn “arousal” device is designed to prevent respiratory arrest and death from opioid overdose. It is intended to continuously monitor SpO2 (blood oxygen levels) in post-operative patients and at-home users receiving opioids and to arouse them to breathe if SpO2 decreases below 90%, the company says. A clinical trial is planned at a major medical center soon, it says.