Scalp cooling tech provider gains expanded FDA approval

Provider of medical scalp cooling technology, Dignitana, has announced that it has received clearance from the US Food and Drug Administration, to expand the use of its medical device to patients in the US receiving chemotherapy for solid tumour cancers.

The company manufactures the DigniCap Scalp Cooling System, which was originally cleared by the FDA in 2015 as the first scalp cooling device to be used for women with breast cancer.

This year nearly 800,000 new cases of solid tumour cancers were diagnosed and over six million patients receive diagnoses worldwide.

Dignitana’s expanded FDA clearance means oncologists and surgeons treating cancer patients with solid tumours will be able to consider scalp cooling treatments for patients receiving chemotherapy.

Johan Ericsson, chief executive officer of Dignitana, said: “Scalp cooling is recognised around the world as a safe and effective therapeutic solution to one of the most traumatic side effects of chemotherapy. 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.”

The company state that with expanded FDA clearance, it can work with its cancer centre partners to make treatments available on a larger scale.

William Cronin, chief executive officer of Dignitana, said: “Dignitana’s mission remains focused on providing cancer patients with the best possible care and outcomes as they undergo treatment. As the first in the U.S. to provide an FDA-cleared solution to prevent chemotherapy induced hair loss, we’ve seen first-hand the tremendous impact this new technology can have on patient wellbeing. Together with our medical centre 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 tumours each year.”