Paxman's neuropathy device application moves to FDA substantive review
The FDA completed the acceptance review of Paxman's De Novo application for its neuropathy device and advanced it to detailed evaluation. 134 review days remained.
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what happened
The FDA has completed the acceptance review of the De Novo application for the Paxman Neuropathy device and moved it into substantive review, Paxman said in a press release distributed via TradingView. The regulator considers the submission complete enough for detailed assessment of clinical, technical and supporting evidence.
The target review period for such an application is 150 review days from October 26, 2026, and 134 days remained at the time of the release. The timeline may shift: if the FDA requests more information, the review clock pauses until the company responds. CEO Richard Paxman said such requests are a normal part of the process and that De Novo reviews typically take roughly six to twelve months.
why it matters
For investors this is a regulatory milestone rather than an approval, since the FDA has not yet decided on the device. The next key event will be an FDA decision or a material update on information requests. The company is small, so the news is unlikely to move markets beyond its Nasdaq First North shares.
tags
instruments
sources
- PAXMAN AB (publ) (PAX) FDA Advances Neuropathy Device Application to Substantive Review — TradingView, 13 November 2026 at 11:45 UTC
- Paxman Announces FDA Advancement of Its Neuropathy Device De Novo Application to Substantive Review — TradingView, 13 November 2026 at 11:45 UTC
prepared by the newsmetry newsroom with ai assistance from the sources listed below. not investment advice.
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