Masimo announced that it received FDA de novo classification for its Bridge neuromodulation-based opioid withdrawal device.

Bridge uses neuromodulation to aid in reducing the symptoms associated with opioid withdrawal. Irvine, Calif.-based Masimo touts it as the first evidence-based, drug-free, non-surgical device of its kind.

The wearable, single-patient-use, percutaneous neurostimulator fits behind the ear and applies gentle electrical impulses to branches of the cranial nerves around the ear, reducing heightened neuron activity associated with opioid withdrawal symptoms. It can be easily applied by a healthcare professional in a non-surgical procedure and doesn’t interfere with normal daily activities.

Bridge aims to reduce the withdrawal symptoms to help patients with opioid-use disorder (OUD) transition away from opioids into an appropriate treatment program. Masimo said in a news release that the device was found to reduce opioid withdrawal symptoms within 15-30 minutes and provide continuous relief for as long as it was applied, which can be up to 120 hours per device.

A study of 73 adult OUD patients revealed that withdrawal symptoms were reduced by 85% after the first hour of using the device and 97% after five days of use, using the clinical opiate withdrawal scale.

“The opioid epidemic continues to impact millions of people around the world,” Masimo founder & CEO Joe Kiani said in the release. “Unassisted withdrawal from long-term use can be lengthy, extremely unpleasant, and there is a high risk of relapse. Effectively helping to reduce opioid withdrawal symptoms, which is what Bridge has been shown to do, is a critical first step toward successful illicit opioid cessation and treatment.

“This is the first tool that we are introducing to help with the opioid epidemic. We are committed to doing what we can to help reduce opioid-related deaths.”

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