Irvine, California-based Masimo now offers the first and only FDA-cleared monitoring system for detecting opioid-induced respiratory depression.
The company said in a news release that it also became the first winner of an FDA Opioid Innovation Challenge. In 2018, the FDA selected Masimo to develop a device that could help prevent opioid overdose as part of this challenge, the company said.
De Novo authorization allows for the over-the-counter availability of Opioid Halo. Adults and children aged 15 and up can purchase it without a prescription. Healthcare providers can also offer an Rx version for use by prescription.
Opioid Halo uses an advanced pattern recognition algorithm to detect and quantify the risk of severe opioid-induced respiratory depression. It combines with distributed architecture to manage and send escalating alarms to family members, friends and caregivers. Halo notifies that help may be required due to an opioid overdose. That includes triggering an automatic wellness call that may lead to the dispatching of EMS.
Masimo founder and CEO Joe Kiani called the opioid crisis “so devastating in its impact on the young” that it lowered overall U.S. life expectancy. He said the company is “very excited” to offer a new solution to combat the opioid crisis.
“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,” Kiani said. “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.”
More about the Masimo Opioid Halo
Masimo designed the Halo to identify the symptoms of an opioid overdose by detecting physiological markers. These markers present themselves during opioid-induced respiratory depression. Ideally, they help users know when intervention becomes necessary. That could include administering a potentially life-saving dose of naloxone. Interestingly, the FDA just last week approved over-the-counter Narcan (naloxone nasal spray).
Opioid Halo can offer help in the home or in the hospital or another care setting, Masimo said. It features a tetherless, adhesive fingertip sensor and a reusable Masimo SET pulse oximeter and Bluetooth chip. The system offers a Bluetooth-to-Wi-Fi Masimo Home Medical Hub and a smartphone app, too.
The fingertip sensor provides real-time monitoring. Masimo’s system wirelessly relays data from the sensor and chip to the Home Medical Hub and smartphone app. These platforms continuously analyze physiological data for trends and patterns associated with opioid-induced respiratory depression.
Upon early onset, the system delivers an audible and visual alarm. If risk scores worsen, in addition to repeated alarms, Halo sends automatic texts to designated friends and family members. These texts inform users that they may need to intervene. Finally, an optional setting enables a service center to place an automatic wellness call to the user. This can result in the dispatching of EMS.
“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.”
The analyst’s view
BTIG analyst Marie Thibault wrote in a report that Masimo previously suggested a market opportunity as large as $4.5 billion in this space. She expects Masimo to seek reimbursement.
“It is unclear if the planned go-to-market strategy has remained the same, but the company expected to focus on surgeons and pain specialists, both high-volume prescribers of opioids, as the appropriate sales target,” Thibault wrote.
Additionally, Thibault said questions remain as analysts await more details on commercial rollout plans. She also said issues linger over a less-than-stellar start to the system’s rollout in some European countries.
“[Masimo] had launched the SafetyNet Opioid System in a few European countries, but management has previously described the early response as underwhelming,” Thibault explained.
