TEL AVIV, Jan 9 (Reuters) - Brainsway received U.S. Food and Drug Administration approval for use of its Deep TMS device for the treatment of depression in patients who fail to respond to medication.
The FDA certification of the Deep TMS (transcranial magnetic stimulation) device for such a broad indication demonstrates the device’s efficacy and safety in treating depression and could be a key milestone in changing the treatment for depression, Israel’s Brainsway said in a statement on Wednesday.
The company estimates the U.S. market at tens of billions of dollars a year.
Brainsway said it was evaluating how to market and distribute the device in the United States and other countries, including collaboration with experienced companies in the sector.
Brainsway’s shares were up 16.3 percent to 38.6 shekels in afternoon trade in Tel Aviv.