Paxman says FDA flags De Novo review path for limb cryocompression system to cut chemo neuropathy

• Paxman said the FDA has set the De Novo pathway to review its Limb Cryocompression System for reducing chemotherapy-induced peripheral neuropathy.
• The agency deemed the indication a new intended use, ruling out the 510(k) route.
• A successful De Novo review would create a new device classification, potentially making Paxman first to win US clearance for CIPN cryocompression.

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.