Soterix Medical said today it won FDA 510(k) clearance for its IontoDC device designed to use direct current to introduce ions of soluble salts and other drugs into the body.
The New York-based company said that the newly-cleared IontoDC device provides 10, 20, 30 or 40 minutes of direct current at intensities varying between 1 and 2 mA, and includes resistance meters and automatic ramp up and down.
“This clearance represents a significant milestone for our organization as we can now offer the IontoDC system to the medical community in the U.S. The IontoDC was designed for ease-of-use including simple controls and clear status displays.” regulatory affairs VP Renato Moratore said in a prepared statement.
“The FDA clearance of this system builds on the reputation of Soterix Medical in providing equipment engineered to the highest medical device standards. The IontoDC technology is proven to provide exceptionally reliable and consistent performance.” CTO Dr. Abhishek Datta said in a press release.
Last September, Soterix Medical said it won Health Canada approval for and launched its PainX transcranial direct current stimulation technology designed for treating pain disorders in adults.
The PainX tDCS system is a non-invasive, battery-powered device designed to deliver mild current to a specific section of the cerebral cortex to modulate reaction to painful experiences or control pain perception, Soterix said. The company touted the device as a “highly-promising therapy” that avoids systemic side effects associated with oral pain medications.