electroCore, Inc. Submits 510(k) Premarket Notification to FDA Seeking Clearance of Quell® for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Key Highlights
- ➤electroCore (ECOR) submits FDA 510(k) seeking Quell clearance for chronic CIPN
- ➤Clinical studies included 168 subjects, including a 142-subject randomized controlled trial
- ➤Quell cut neuropathic pain approximately 40% versus 24-33% for sham treatment
- ➤Randomized trial showed EORTC-CIPN20 improvement of 11.6% versus 8.7% sham
- ➤FDA clearance is not guaranteed and may require additional information or clinical data
Expert Statements
Peter S. Staats, M.D., MBA, Chief Medical Officer of electroCore
“Chemotherapy-induced peripheral neuropathy can persist long after cancer treatment has ended and can have a profound impact on patients’ daily lives.”
Peter S. Staats, M.D., MBA, Chief Medical Officer of electroCore
“The clinical evidence supporting this submission is particularly encouraging because it includes data from a randomized controlled trial shows encouraging improvements in symptoms that matter to patients, including neuropathic pain and quality of life.”
Peter S. Staats, M.D., MBA, Chief Medical Officer of electroCore
“Following our interactions with the FDA, we have determined to pursue the 510(k) pathway for this indication.”
Peter S. Staats, M.D., MBA, Chief Medical Officer of electroCore
“Submitting our 510(k) is an important step toward potentially bringing patients and clinicians a non-pharmacologic treatment option for this difficult-to-treat condition, and we look forward to continuing to work closely with the Agency during its review.”
ROCKAWAY, N.J., Oct. 28, 2026 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), (“electroCore” or the “Company”), a bioelectronic technology company, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking 510(k) clearance for its Quell® wearable neuromodulation platform (“Quell”) for the treatment of chronic chemotherapy-induced peripheral neuropathy (CIPN).
CIPN is a common and potentially persistent complication of certain neurotoxic cancer therapies that can significantly affect pain, sensation, physical function, and quality of life. There are currently no drugs or devices approved or cleared by the FDA with an indication specific to CIPN. Current management relies on therapies approved or cleared for other conditions, including off-label treatments. If cleared, Quell would be [among] the first FDA-cleared device[s] with a labeled indication specifically for chronic CIPN.
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