The Medical Device Business Journal — Medical Device News & Articles | MassDevice
MASSDEVICE ON CALL — Brain stimulation using electrical currents is a safe and effective depression therapy and may even have other surprise perks for the body, according to research conducted at the University of New South Wales.
More than half of all patients in what researchers called the largest and most definitive study of transcranial direct current stimulation experienced "substantial improvements" after getting the therapy, according to a press release.
Consumer advocacy group Public Citizen petitioned the FDA to require a more stringent standard for cranial electrotherapy stimulator devices, after a panel of agency experts recommended that the products not be downgraded to a lower-risk category.
The FDA’s Neurological Devices Panel met last month to discuss whether CES devices need more regulatory oversight, concluding that "since the benefits did not outweigh the risks, the device should be Class III."
The FDA set a date in February for the public meeting on whether cranial electrotherapy stimulators need increased regulatory oversight.
The devices, heretofore cleared for the U.S. market via the 510(k) process, apply electrical currents to the brain through the skin for the treatment of anxiety, depression, insomnia and pain.
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.
