TEL AVIV Jan 9 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
Brainsway's shares were up 16.3 percent to 38.6 shekels in
afternoon trade in Tel Aviv.