Masimo Granted De Novo for the First FDA-Authorized Opioid Overdose Prevention, Alert System

IRVINE, California—Masimo announced that Masimo Opioid Halo, an opioid overdose prevention and alert system, has been granted a De Novo by the FDA, making it the first and only FDA-cleared monitoring solution for detecting opioid-induced respiratory depression, the leading cause of death from opioid overdose. With the De Novo, Masimo also becomes the first winner of an FDA Opioid Innovation Challenge to have an authorized solution designed to help solve the U.S. opioid crisis.

The De Novo authorizes Opioid Halo to be made available over the counter (OTC) without a prescription, for use on adults and children age 15 and up, and an Rx version for use by prescription from a health care provider. Opioid Halo advances the forefront of continuous monitoring through its unique Opioid Halo engine, an advanced pattern recognition algorithm that helps detect and quantify the risk of severe opioid-induced respiratory depression. Combined with its innovative distributed architecture, Opioid Halo helps to manage and send escalating alarms to family members, friends and caregivers, notifying them that help may be needed due to an opioid overdose—including triggering an automatic wellness call, which may lead to emergency medical services (EMS) being dispatched.

“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 U.S.,” 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. In 2018, we were honored to be chosen by the FDA, based on our expertise in patient monitoring technologies, to develop a device that could help prevent opioid overdose, as part of their Innovation Challenge addressing the opioid epidemic. We are delighted to have received the first De Novo for our response to that Innovation Challenge, Masimo Opioid Halo. Between then and now, the COVID-19 pandemic accelerated our development and refinement of the Masimo SafetyNet family of remote patient management and telehealth solutions, helping save many COVID patients’ lives. We thank the FDA for taking on the opioid epidemic and granting this De Novo—a clearance that is a huge step forward in preventing overdose deaths and helping to end the opioid crisis.” 

Opioid overdose is the leading cause of accidental death in the U.S., responsible for more than 80,000 of the approximately 100,000 drug-related deaths in 2021, from both illicit opioids, such as fentanyl and heroin, and prescription opioids. Hundreds of thousands more suffer non-fatal overdose events or the loss of a family member or friend to opioids. Opioids are readily prescribed in the U.S., with more than 143 million opioid prescriptions written in 2020, because they can be an effective way to help people manage pain, including after surgery or for chronic conditions. However, opioids also carry serious side effects, especially opioid-induced respiratory depression—slowed or stopped breathing—which is the leading cause of death from opioid overdoses. Anyone taking opioids, prescription or illicit, is at risk of experiencing an accidental overdose, the signs of which are unpredictable and can be difficult to detect. 

“Painkillers often called ‘opioids’ can have negative side effects, including opioid-induced respiratory depression,” said Kim Bennion, system director of research for respiratory care clinical services at Intermountain Health, a 33-hospital system based in Salt Lake City, Utah. “Intermountain Health has demonstrated that home monitoring of post-surgical patients receiving opioids for pain can help identify issues earlier and avoid adverse outcomes.  As a registered respiratory therapist and leader in the field of opioid-induced respiratory depression in the post-surgical setting, we are excited that Masimo’s breakthrough device will be available for our patients.”

Masimo Opioid Halo is designed to help family and friends identify the symptoms of an opioid overdose by detecting physiological markers present during opioid-induced respiratory depression, and ideally, helping them know when it’s time to intervene. For example, by administering a potentially life-saving dose of naloxone. Opioid Halo can be used at home or in the hospital or in other care settings, by patients prescribed opioids after surgery or managing a chronic or prolonged condition, as well as people suffering from opioid use disorder.

The Opioid Halo system consists of four components:

1. A tetherless, adhesive fingertip sensor
2. A reusable Masimo SET pulse oximeter and Bluetooth chip
3. A Bluetooth-to-Wi-Fi Masimo Home Medical Hub
4. A smartphone app

The fingertip sensor provides real-time monitoring for opioid-induced respiratory depression, enabled by the Opioid Halo pattern recognition algorithm and Masimo SET, Signal Extraction Technology—even during movement, when hands are cold, and on all skin pigmentations. Data from the sensor and chip are wirelessly relayed to the Masimo Home Medical Hub and the smartphone app, which continuously analyzes the user’s physiological data for trends and patterns associated with the physiology of an opioid-induced respiratory depression event to quantify the risk of an opioid overdose. As the level of risk rises, the app and hub provide alerts. Upon early onset, an audible and visual alarm, designed to trigger early intervention opportunities for the user to self-recover or get help, is provided. If the Opioid Halo risk score continues to worsen, in addition to the repeated alarms, automatic texts are sent to designated friends and family members, letting them know it may be time to intervene, for example, by administering naloxone or taking other action. Finally, if the severity of the risk level progresses even further, there is an optional setting that can be activated during setup that enables a service center to place an automatic wellness call to the user, the outcome of which may lead to EMS being dispatched.

“My son Parker lost his life after taking prescription opioids to manage his pain after a tonsillectomy,” said Yvonne Gardner, now a patient safety advocate. “No one warned us that this could happen. This technology can help save other parents from losing a child.”

“For more than 30 years, Masimo has been empowering clinicians with life-saving technologies that improve outcomes for countless patients around the world,” Kiani said. “Opioid Halo furthers our mission to expand beyond the hospital and into the home, empowering everyday people with a solution that we believe has the power to improve and save many more lives.”

For more information about Masimo Opioid Halo, and to pre-order it today for a loved one, a community hero, or an organization, visit opioidhalo.com.