FDA Clears Monitoring Device That Detects Opioid-Induced Respiratory Depression

The Food and Drug Administration (FDA) has granted marketing authorization for the Masimo Opioid Halo^™, an opioid overdose prevention and alert system.

Using a tetherless, adhesive fingertip sensor, the device monitors several physiological markers to detect the impairment of oxygenation due to opioid use. The data is then sent wirelessly to the Masimo Home Medical Hub and the Opioid Halo App. Using an advanced pattern algorithm, the system is able to recognize and quantify the risk of severe opioid-induced respiratory depression.

Audible and visual alarms are triggered early to allow the user to self-recover or get help. As the level of opioid-induced respiratory depression risk increases, the system begins to send escalating notifications to the user and their emergency contacts. If the risk continues to rise, the system can trigger an automated wellness call that may lead to emergency services being dispatched; this is an optional setting that would need to be activated during the setup.

“We are very excited to be able to offer this solution to our fellow Americans and the community heroes who are helping to battle the opioid crisis – a crisis so devastating in its impact on the young that it has lowered overall life expectancy in the US,” said Joe Kiani, Founder and CEO of Masimo. “Now, with Opioid Halo, we hope to help make a big difference by providing a much needed tool that can help millions, whether they are taking prescribed opioids or struggling with illicit opioid use.

The FDA’s De Novo authorization allows for both prescription and over-the-counter (OTC) use of the Opioid Halo system in adults and children 15 years of age and older. The Company will begin shipping the system, which retails for $249.99, in May 2023; it is available for pre-order now.