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FDA expands Dignicap clearance in the US


Dignitana has received clearance from the U.S. Food and Drug Administration (FDA) to expand use of its medical device to patients in the United States receiving chemotherapy for solid tumor cancers.

Originally cleared in December 2015 by the FDA as the first scalp cooling device for use in women with breast cancer, the clinically-tested automated scalp cooling device is administered in medical facilities as patients receive their chemotherapy infusion.

“Scalp cooling is recognized around the world as a safe and effective therapeutic solution to one of the most traumatic side effects of chemotherapy,” said Johan Ericsson, Chief Executive Officer of Dignitana AB. “Dignitana takes great pride in our ability to lead the way and remain at the cutting edge of technological developments that provide a transformative quality of life experience for people coping with a cancer diagnosis. This FDA decision allows us to help even more patients in the U.S. as they navigate life with the disease.”

“Dignitana’s mission remains focused on providing cancer patients with the best possible care and outcomes as they undergo treatment,” said William Cronin, Chief Executive Officer of Dignitana, Inc. “As the first in the U.S. to provide an FDA-cleared solution to prevent chemotherapy induced hair loss, we’ve seen firsthand the tremendous impact this new technology can have on patient wellbeing. Together with our medical center partners we are working to lessen the emotional burden that so many patients have faced until now. We hope this expanded FDA clearance will be welcome news for thousands of Americans diagnosed with solid tumors each year.”

DigniCap is available at more than 80 clinical sites across 21 states in the United States.