Alpha-Stim launched a campaign to change a proposed FDA ruling regarding pre-market approval for its cranial electrotherapy stimulation devices.

The FDA is proposing a rule that would require pre-market approval of CES devices, which have heretofore been cleared for the U.S. market via 510(k) process for the treatment of anxiety, depression, insomnia and pain.

Since the announcement, the federal watchdog agency has received more than 100 written objections by patients and medical professionals vouching for device safety, efficacy and lack of side effects on behalf of Alpha-Stim.