+ Regulatory
Robert Hadley | Jul 15, 2017

FDA approves use of cooling cap to stall hair loss from chemotherapy

Chemotherapy may save lives, but it can also cause hair loss in patients, an unpleasant side effect that a special cap developed by pharmaceutical device maker Dignitana aims to prevent.

The company's DigniCap Cooling System recently received FDA approval for patients receiving chemotherapy for solid tumor cancers, a company release said. The device routes coolant to the scalp during treatment and insulates to keep cool air next to the skin. According to the release, this stanches blood vessels and minimizes hair follicle exposure to chemical agents.

"We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss," Dr. Binita Ashar, who directs the FDA's Center for Devices and Radiological Health, said in a July 3 press release. "Managing the side effects of chemotherapy is a critical component to overall health and quality of life."

The FDA authorization comes two years after DigniCap received trial approved for use by breast cancer patients. The latest  approval expands its use to patients suffering other cancers. The cap may not be used on children or with certain types of cancer or specific chemotherapeutic agents.

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