Monday, November 18, 2024

Monday, November 18, 2024

FDA Market Clearance for new Cranial Electrotherapy Stimulator


A new treatment for anxiety, depression and insomnia may be on the way now that Innovative Neurological Devices received FDA market clearance for its Cervella Cranial Electrotherapy Stimulator (CES).

It is the first CES device to work through an app with conductive treatment electrodes in noise-cancelling, Bluetooth-enabled headphones.

Innovative Neurological Devices hopes this will encourage patients to use the device as prescribed by their doctor and not find it to be a burden in their lives. The app also allows for patients to seamlessly record data, receive reminders, and study analytics.

“Anxiety, insomnia, and depression are disorders affecting at least 20 percent of the adult population,” said president and CEO of Innovative Neurological Devices Bart Waclawik. “Furthermore, recent research brought to light that 70 percent of teenagers list anxiety and depression as the main problem affecting the younger population. For many years, CES devices have been clinically validated as a safe and effective alternative to drug-based therapies without the side-effects that often exist with the use of antidepressants. By making the Cervella device appear indistinguishable from ordinary over-ear headphones, patients will have the freedom to use the device in anxiety-inducing situations without curious looks from onlookers. Last but not least, the automated data aggregation available through the proprietary Cervella app gives a patient an option to easily share treatment data with his or her health provider in order to better manage the treatment plan.”

The product was launched during the Anxiety and Depression Conference on March 28. It is available with a prescription in the U.S. for $695.

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