Masimo has received a De Novo classification from the FDA for Bridge, a neuromodulation device for reducing opioid withdrawal symptoms. The agency assigns the De Novo classification to new devices that are not equivalent to existing Class I or Class II devices.
The neurostimulator is worn behind the ear and delivers gentle electrical impulses to reduce the heightened neuron activity caused by opioid withdrawal. The treatment reduces the severe flu-like symptoms caused by the drug withdrawal.
The device is easily applied to patients by a healthcare professional in a nonsurgical procedure, the company said.