electroCore files a 510(k) for Quell in chemotherapy-induced neuropathy

MedDevice Startups Staff · 1 day ago · 2 min read · Via electroCore release via GlobeNewswire

electroCore submitted a 510(k) premarket notification on October 28 seeking clearance of its Quell wearable neurostimulation platform for chronic chemotherapy-induced peripheral neuropathy. The company says no drug or device currently carries an FDA indication specific to CIPN. Quell is marketed today but is not cleared for that use.

The submission rests on 168 subjects across two studies, a 142-subject randomized sham-controlled trial and a 26-subject open-label feasibility study. Neuropathic pain scores fell about 40 percent in the active arm against about 24 to 33 percent for sham. On the EORTC-CIPN20 quality of life measure the active arm improved 11.6 percent against 8.7 percent for sham, which the company says met a pre-specified significance threshold of 0.2 set for a preliminary efficacy design.

electroCore states in the release that FDA may find Quell not substantially equivalent, which would push it toward a De Novo request or another pathway, or may clear a narrower indication, or may ask for more data.

The 0.2 threshold on the quality of life endpoint is where a reviewer will stop, and the subgroup with moderate to severe baseline pain that showed a 50 percent drop was not pre-specified.

Questions & Answers

What did electroCore submit to FDA on October 28, 2026?

electroCore submitted a 510(k) premarket notification seeking FDA clearance of its Quell wearable neurostimulation platform for the treatment of chronic chemotherapy-induced peripheral neuropathy. Quell is not currently cleared for that indication.

What clinical data supports the electroCore Quell CIPN submission?

electroCore cited 168 subjects from two studies: a 142-subject randomized sham-controlled trial and a 26-subject open-label feasibility study. Neuropathic pain scores fell about 40 percent in the active group against about 24 to 33 percent for sham, and EORTC-CIPN20 quality of life scores improved 11.6 percent against 8.7 percent for sham.

Could FDA reject the electroCore Quell 510(k) for CIPN?

electroCore said FDA may find Quell not substantially equivalent, which could require a De Novo request or another pathway, and that the agency may instead clear a narrower indication or request additional data. The company describes its evidence as preliminary because it comes from a proof-of-concept design.

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