Press release
Masimo Opioid Halo™ Granted De Novo for the First and Only FDA-Authorized Opioid Overdose Prevention and Alert System
Opioid Halo Is Indicated for the Detection of Opioid-Induced Respiratory Depression, with Escalating Alarms to Alert Loved Ones That Help Is Needed De Novo
About this update from Masimo Corporation
[{"type":"text","content":"\nOpioid Halo Is Indicated for the Detection of Opioid-Induced Respiratory Depression, with Escalating Alarms to Alert Loved Ones That Help Is Needed\n\n\nDe Novo Authorizes Both Over-the-Counter (OTC) Use, on Adults and Children Age 15 and Up, and Prescription Use\n\n\n IRVINE, Calif.--(BUSINESS WIRE)--\nMasimo (NASDAQ: MASI) today 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 healthcare provider. Opioid Halo advances the forefront of continuous monitoring through its unique Opioid Halo engine, an advanced pattern recognition algorithm which 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 EMS being dispatched.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230403005131/en/Masimo Opioid Halo™ (Photo: Business Wire)\nJoe Kiani, Founder and CEO of Masimo, said, “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. 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 ...