Soterix Medical Inc., the technology leader in non-invasive electrotherapy devices, announced today it has received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for its IontoDC™ device intended to use a direct current to introduce ions of soluble salts or other drugs into the body.
“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.,” said Mr. Renato Moratore, VP Regulatory Affairs of Soterix Medical. “The IontoDC™ was designed for ease-of-use including simple controls and clear status displays.”
Dr. Abhishek Datta, CTO of Soterix Medical commented that, “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.”
With the FDA clearance of the IontoDC™, Soterix Medical Inc. is announcing the addition of two Field Clinical Specialists to provide support to clinical centers including on-site product training, reimbursement, and customer needs.
The FDA cleared IontoDC™ device provides 10, 20, 30, or 40 minutes of Direct Current with an intensity of 1, 1.5, 1.75, or 2 mA. It includes current and resistance meters, automatic ramp up and down, and comes with an anode and cathode cable.