electroCore Submits FDA 510(k) Notification for Quell CIPN Treatment
electroCore said it submitted a 510(k) premarket notification to the FDA seeking clearance for Quell to treat chronic chemotherapy-induced peripheral neuropathy.
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12:04:16 PM UTC
SquawkNews
Submission backed by clinical data from two clinical studies representing 168 subjects demonstrating quality of life improvements and an approximately 40% reduction in neuropathic pain scores in the active treatment groupROCKAWAY, N.J., Oct. 28, 2026 (GLOBE NEWSWIRE) -- electroCore, Inc. NASDAQ:ECO…
12:05:15 PM UTC
SquawkNews
electroCore submitted a 510(k) to the FDA to clear its Quell wearable for chronic CIPN, supported by two studies (n=168) showing QoL gains and ~40% pain reduction vs ~24—33% sham. There are currently no FDA-cleared therapies with a CIPN-specific indication.Material DetailsContext by AI AnalystThis…