FDA Clears Amma, a Scalp-Cooling Device to Prevent Chemo-Related Hair Loss in Patients With Cancer

The Food and Drug Administration (FDA) granted clearance to Amma, a scalp-cooling device made to prevent chemotherapy-related hair loss in patients with cancer. The device is manufactured by Cooler Heads, a tech company whose CEO, Kate Dilligan, is a breast cancer survivor.

"Cancer patients undergoing chemo are dealing with the hardest challenge one can face; keeping their hair is critical to their mental health, their sense of self, and their recovery process,” Dilligan said in a recent statement. “Scalp cooling is an effective way for cancer patients to save their hair, but existing methods are prohibitively expensive and difficult to use.”

Dilligan stressed the importance of making Amma affordable and accessible to all. When going through treatment for stage 2b breast cancer, she paid $8,000 to keep her hair. She knows that while she was able to afford it, not all patients can.

The Cooler Heads cold cap is sent directly to patients’ homes, where they then undergo remote training. Patients then put the cap on during chemotherapy treatment and keep it on for an additional two hours after treatment ends. The cap can be rented, and it costs about $2,000 for patients — a fourth of what Dilligan paid — according to an interview with MedGadget. When patients finish chemotherapy treatment, they ship Amma back to Cooler Heads.

Cooling caps work by making the scalp cold, causing blood vessels to constrict and thus limiting the amount of chemotherapy that is carried to the hair follicles.

To Dilligan, preventing hair loss is more than just vanity.

“It's about recognizing yourself in the mirror; it's about privacy, dignity, and not letting cancer take your identity from you,” she said.

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