Table 1.

Selection of neural engineering devices recently approved by the US Food and Drug Administration. PMA: premarket approval; HDE: humanitarian device exemption.

Device	Manufacturer or Sponsor	Indication	Year approved	Regulatory path	Innovations
Inspire	Inspire Medical Systems, Inc.	Treat obstructive sleep apnea	2014	PMA	Stimulation of the hypoglossal nerve during inspiration
TrueTear®	Allergan plc	Increase in real tear production	2018	de novo	Electrical stimulation to sensory neurons of the nasal cavities
Maestro®	EnteroMedics, Inc.	Weight reduction in people with obesity	2015	PMA	Electrical stimulation to block abdominal nerve trunks of the vagus nerve
gammaCore™	electroCore, Inc.	Acute treatment of migraine headache	2018	510(k)	Noninvasive vagus nerve stimulation (nVNS) on the side of the neck
Drug Relief®	DyAnsys, Inc.	Reduce opiod withdrawal symptoms	2018	510(k)	Electrical stimulation at branches of cranial nerve
RNS®	NeuroPace, Inc.	Reducing the frequency of seizures for people with epilepsy	2013	PMA	Cranially implantable neurostimulator that senses brain’s electrical activity and delivers stimulation to epileptogenic foci
Argus® II Retinal Prosthesis System	Second Sight Medical Products, Inc.	Inducing visual perception in blind patients due to retinitis pigmentosa	2013	HDE	Electrical stimulation of retina
Medtronic DBS System for Epilepsy	Medtronic, Inc.	Expand use of DBS system for treatment of epilepsy	2018	PMA	Bilateral stimulation of the anterior nucleus of the thalamus