Paxman pursues FDA De Novo route for CIPN indication after 510(k) setback

• Paxman’s Limb Cryocompression System for CIPN will not qualify for a 510(k) review, based on FDA feedback.
• FDA directed the program to the De Novo pathway, extending the U.S. regulatory timeline for the CIPN indication.
• The device already holds UK and EU clearances for reducing CIPN, supporting European commercialization plans while the U.S. filing advances.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Paxman AB published the original content used to generate this news brief on August 10, 2026, and is solely responsible for the information contained therein.