Masimo opioid overdose alert system Halo gets FDA De Novo tag
Iryna Drozd
- Masimo (NASDAQ:MASI) said the U.S. FDA granted De Novo to Masimo Opioid Halo, an opioid overdose prevention and alert system.
- The status makes the system the first and only FDA-cleared monitoring solution for detecting opioid-induced respiratory depression, according to the company.
- The company added that the De Novo authorizes Opioid Halo to be made available over the counter (OTC) without a prescription for use by people aged 15 years and above, and an Rx version for use by prescription from a healthcare provider.
- Opioid Halo sends alarms to family, friends and caregivers, notifying them that help may be needed due to an opioid overdose – including an automatic call, which may lead to EMS being dispatched.
- The FDA's De Novo request provides a marketing pathway to classify novel medical devices for which general controls provide reasonable assurance of safety and effectiveness for the intended use. However, for these devices there are no legally marketed predicate device. De Novo classification is a risk-based classification process, according to the FDA.