Dignitana Completes Patient Recruitment in a Multi-Center Pivotal Trial for FDA approval in the United States
Dignitana on track with U.S. Premarket Approval (PMA)Dignitana AB, a world leader in medical scalp-cooling technology for reducing hair loss related to chemotherapy, is pleased to announce that it has completed patient recruitment in the multi-center pivotal trial of the patented DigniCap® System. Dignitana is conducting a Premarket Approval (PMA), a regulatory process with the aim to obtain product and market approval for the DigniCap® System in the United States (U.S.) by the Food and Drug Administration (FDA). Dignitana obtained approval from the FDA to implement a module based