Masimo secures FDA De Novo clearance for Masimo Opioid Halo system

2023-04-04

The De Novo authorisation will enable the OTC availability of Opioid Halo for adults and children aged 15 and over without the need for prescription Masimo Opioid Halo system. (Credit: Business Wire) Masimo has received De Novo authorisation for its Masimo Opioid Halo system from the US Food and Drug Administration (FDA) to detect opioid-induced respiratory depression. According to the California-based medical technology company, Masimo Opioid Halo is now the first FDA-cleared opioid overdose prevention and alert system. The De Novo authorisation will enable the over-the-counter (OTC) availability of Opioid Halo for adults and children aged 15 and over without the need for prescription. Healthcare providers can also provide an Rx version of the system for use by prescription. Designed to be worn on the wrist, the monitoring solution identifies and quantifies the risk of severe opioid-induced respiratory depression using the Opioid Halo engine, which is an advanced pattern recognition algorithm. Masimo said that Opioid Halo has a distributed architecture to manage and send alarms to family members, friends, and caregivers. It notifies them about opioid overdose, including an automatic wellness call which could lead to emergency medical services, (EMS) being dispatched. Masimo founder and CEO Joe Kiani said: “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 honoured 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. “And today, we are delighted to have received the first De Novo for our response to that Innovation Challenge, Masimo Opioid Halo.” The medical technology company has designed the Opioid Halo to detect the signs of an opioid overdose by identifying physiological markers. It can be used at home, hospital, or care setting by patients prescribed opioids post-surgery or managing a chronic or prolonged condition, as well as people suffering from opioid use disorder, Masimo said. It features a tetherless, adhesive fingertip sensor, a reusable Masimo SET pulse oximeter, a Bluetooth chip, and a Bluetooth-to-wi-fi Masimo home medical hub, and a smartphone app.

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