PAXMAN announces FDA clearance for an expanded indication of its scalp cooling system in the US
PAXMAN’s advanced scalp cooling system has now been cleared by the US Food and Drug Administration (FDA) for use during treatment of patients with solid tumours. The expanded FDA clearance substantially increases the potential number of new cancer patients per year that the system can be marketed to in the USA – from an estimated 250,000 breast cancer patients to over one million breast cancer and solid tumour cancer patients.PAXMAN’s 510k application for expanded use of its scalp cooling system was submitted to the US Food and Drug Administration (FDA) in October 2017, and was thereafter