FDA grants de novo authorization to opioid overdose prevention, alert system

Key takeaways:

• The FDA granted de novo approval to Masimo for an opioid overdose prevention and alert system.
• The approval makes it the only FDA-approved product that detects the top cause of death from opioid overdose.

The FDA has granted de novo authorization for an opioid overdose-related prevention and alert system , according to a press release from the manufacturer.

The Opioid Halo system from Masimo, a medical technology company, is the first product for detecting opioid overdose-related respiratory depression to receive FDA approval, according to the press release.

Under the authorization, Masimo’s Opioid Halo system can be acquired over the counter without a prescription for people aged 15 years or older. A prescription version can also be acquired when prescribed by a health care provider, according to the release.

Using an adhesive fingertip sensor and a reusable Masimo SET pulse oximeter and Bluetooth chip, the Opioid Halo system monitors for opioid-induced respiratory depression and conveys the data in real-time to the Masimo Home Medical Hub and an associated smartphone app. The hub and app alert the user as the risk for respiratory depression increases.

When respiratory depression begins, an audible and visible alarm will alert the user to get help or recover on their own. As respiratory depression gets worse, friends and family will receive automatic texts about the situation. During system set-up, the user can choose to enable a service center to call the user if symptoms continue to worsen, which may lead to emergency medical services to be called, according to the release.

“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.,” Joe Kiani, MS, founder and CEO of Masimo, said in the release. “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.”

The approval makes Opioid Halo the first winner of the FDA Opioid Innovation Challenge to be authorized by the administration.