www.fdanews.com/articles/200809-spark-biomedicals-opioid-withdrawal-treatment-earns-fda-ok
Spark Biomedical’s Opioid Withdrawal Treatment Earns FDA OK
January 11, 2021
The FDA has granted 510(k) marketing clearance for Spark Biomedical’s Sparrow Therapy system, a wearable neurostimulator for treating opioid withdrawal.
The system, which is designed to be worn up to 24 hours a day during detoxification, stimulates nerves on and around the ear to help reduce withdrawal symptoms.
The Sparrow system is “the first clinically proven, drug-free, needle-free, wearable neurostimulation solution for opioid withdrawal relief,” offering an alternative to treatments that use drugs or acupuncture, Spark said.