FDA approves DigniCap scalp cooling system to reduce chemotherapy induced hair loss- Dignitana
Dignitana, a world leader in medical scalp-cooling technology, announced that the FDA has granted the company’s de novo application to market the DigniCap scalp cooling system, designed to reduce the severity of chemotherapy-induced hair loss. After rigorous clinical studies and wide use overseas the DigniCap scalp cooling system is now FDA-cleared for use in the United States. The system, which is the only such device to have completed an FDA approved multi-center clinical trial, is used by patients undergoing chemotherapy infusion, and is cleared for use with treatment regimens associated with breast cancer.
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