The DigniCap is made by Dignitana AB of Sweden. The company will lease the device to cancer centers and patients will be charged a fee for each use, the Associated Press reported.
A half-hour before a chemotherapy session, the patient puts on a tight-fitting cap connected to a cooling machine. The device gradually chills the scalp, which becomes numb by the time chemotherapy infusion begins.
The cooling system is used throughout the treatment and for about an hour and a half after chemotherapy ends, the AP reported.
The DigniCap was tested on 122 early-stage breast cancer patients receiving standard chemotherapy. More than two-thirds of those who used the device kept their hair. Common side effects were cold-induced headaches, neck and shoulder discomfort, and chills and pain, according to the FDA.
Scalp cooling is meant to temporarily reduce blood flow and cell metabolism in the scalp, reducing the amount of chemotherapy drugs that reach and harm hair follicles. Several types of cold caps are available worldwide, the AP reported.
While some question if such devices could prevent chemotherapy drugs from reaching cancer cells in the scalp, the FDA said the chance of that "is extremely rare."
"Because women tend to survive early breast cancer for so many years, the FDA should provide the evidence to show if there's any long-term risk," Dr. Len Lichtenfeld, of the American Cancer Society, told the AP.
Patients should discuss the use of the cooling cap with their doctors, he advised.