Dignitana Receives FDA Clearance to Market DigniCap Cooling System
The FDA has awarded Lund, Sweden-based Dignitana clearance to market its DigniCap Cooling System, a cooling cap to reduce hair loss in female breast cancer patients being treated with chemotherapy.
Specifically, the device is indicated for patients being treated with alopecia-inducing chemotherapeutic agents and doses.
The computer-controlled system circulates cooled liquid to a head-worn cooling cap during chemotherapy treatment with the aim of constricting blood vessels in the scalp to reduce the amount of chemotherapy that reaches the hair follicles.
The system met its primary endpoint in a clinical trial using self-assessment of hair loss by the women using standardized photographs at one month after the last chemotherapy cycle. — Michael Cipriano