The FDA has cleared its first wearable device designed to help prevent opioid overdoses, with an alert system that sounds the alarm if breathing slows.
Developed by Masimo, the Opioid Halo device checks for drug-induced respiratory depression, a specific condition that stands as the leading cause of death from an overdose.
The agency’s de novo clearance enables its sale both over-the-counter for the general public in addition to a prescription version aimed at front-line healthcare providers. Designed to be worn by people ages 15 and up, the Opioid Halo attaches to the hand and wrist and uses a pattern recognition algorithm to quantify the risks of severely slowed breathing by continuously measuring the levels of oxygen in the bloodstream.
When the wearer is in danger, the device can deliver escalating alarms and send text messages to family members, friends and caregivers to notify them that help may be needed—such as a dose of the opioid-countering naloxone, which was recently approved for over-the-counter use—as well as dispatch an automatic call to emergency services.
The Opioid Halo has been a project in the works for years. Masimo was tapped by the FDA in 2018 for an innovation challenge to develop a monitoring device aimed at the opioid epidemic, while overdoses continue to be the leading cause of accidental deaths in the U.S.
Since then, the COVID-19 pandemic only accelerated the company’s development of its SafetyNet family of remote patient management and telehealth programs, Masimo CEO Joe Kiani said in a release.
Now, the Opioid Halo is designed to potentially reach millions of people, Kiani added, whether they are taking prescription opioids or struggling with illicit opioid use. The company estimates that drugs including fentanyl, heroin and prescription opioid painkillers accounted for more than 80,000 of about 100,000 drug-related deaths in 2021, with hundreds of thousands more having nonfatal overdoses.