Paxman's Limb Cryocompression System Application to Undergo US FDA's De Novo Process

01:12 AM EDT, 08/11/2026 (MT Newswires) -- Paxman (PAX.ST) said Monday that the US Food and Drug Administration will implement the De Novo process to review its Limb Cryocompression System for the reduction of chemotherapy-induced peripheral neuropathy. The Swedish scalp cooling company noted that the regulatory pathway will stretch its approval timeline. However, a potential approval could make Paxman the first company to lower or prevent chemotherapy-induced peripheral neuropathy using cryocompression technology in the US. The Limb Cryocompression System is already approved for the said indication in the UK and Europe.