Dear Friends & Colleagues,
I am pleased to report that our meeting with the FDA’s Neurological Devices Panel on February 10th yielded a favorable result. The Panel, comprised of top doctors from the fields of neurosurgery, psychiatry, neurology and sleep medicine, unanimously voted that CES is a safe therapy that carries no significant risk.
In voting whether CES research, most of which was performed between the early 1970’s and the 1990’s, is strong enough to pass contemporary standards of effectiveness, the Panel was divided, which we expected. Of note is that Dr. Suresh Kotagal, a renown sleep doctor at Mayo Clinic, and Dr. Richard Fessler, a neurosurgeon at Northwestern University School of Medicine, were among the Panelists who voted that CES research was indeed strong enough to pass contemporary standards of effectiveness.
This is truly a landmark moment in the history of CES. With the Panel unanimously voting that CES has no significant risk, it is unlikely that the FDA will decide to keep CES in Class 3, which is reserved for the highest risk devices. We feel confident that as a result of this panel decision, the FDA will move CES into Class 2, a low to moderate risk class that was granted to TMS last year. A final decision will take several months.
Thank you for your interest and support, and please let me know if you have any questions.
Sincerely,
Charles A. Fisher
President
Fisher Wallace Laboratories
P.S. We are offering a significant discount to clinicians and researchers who wish to purchase a device. Please email my assistant Ana Ostojic (ana@fisherwallace.com) if you would like one.
|
|
