"the US Food and Drug Administration FDA cleared for marketing in the United States the first cooling cap to reduce alopecia in female breast cancer patients undergoing chemotherapy. Hair loss is a common side effect of certain types of chemotherapy commonly associated with the treatment of breast cancer. Hair may fall out entirely gradually in sections or may become thin. Hair loss due to cancer treatment is usually temporary but minimising or relieving these kinds of side effects are considered important to overall treatment. The Dignitana DigniCap Cooling System is indicated to reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients in which alopeciainducing chemotherapeutic agents and doses are used. It is a computercontrolled system that circulates cooled liquid to a headworn cooling cap during chemotherapy treatment. The cooling cap is covered by a second cap made from neoprene which holds the cooling cap in place and acts as an insulation cover to prevent loss of cooling. The cooling action is intended to constrict blood vessels in the scalp which in theory reduces the amount of chemotherapy that reaches cells in the hair follicles. The cold also decreases the activity of the hair follicles which slows down cell division and makes them less affected by chemotherapy. The combined actions are thought to reduce the effect chemotherapy has on the cells which may reduce hair loss. DigniCap may not work with some chemotherapy regimens. Interested patients should talk with their doctors. The efficacy of the cooling system was studied in  stage I and stage II women with breast cancer who were undergoing chemotherapy using recognised chemotherapy regimens that have been associated with hair loss. The data from this study may also be applied to some stage III and IV breast cancer patients because they may have a benefitrisk profile comparable to the patients enrolled in this study. The primary endpoint was a selfassessment of hair loss by the women using standardised photographs at one month threesix weeks after the last chemotherapy cycle. More than  of patients treated with the DigniCap reported losing less than half their hair.  Prevention of hair loss in these patients may be a significant benefit to their quality of life and the risk of the chemotherapy drug missing an isolated grouping of the breast cancer cells in the scalp because of the cold cap is extremely rare.   The most common side effects of the cooling system include coldinduced headaches and neck and shoulder discomfort chills and pain associated with wearing the cooling cap for an extended period of time. The FDA reviewed data for DigniCap cooling system through the de novo classification process a regulatory pathway for some low to moderaterisk devices that are novel and not substantially equivalent to any legally marketed device.  The DigniCap Cooling System is manufactured by Dignitana Inc. in Lund Sweden."