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Dignitana receives FDA clearance

The United States Food and Drug Administration has cleared DigniCap Delta for use by U.S. health care providers.

The new device is the fourth generation of The DigniCap Scalp Cooling System and is indicated to prevent chemotherapy-induced hair loss in patients with solid tumors.

European installations of DigniCap Delta began last month after the device received CE Marking in March 2019.

DigniCap Delta

“DigniCap Delta changes everything about the way scalp cooling is done today,” said William Cronin, CEO of Dignitana. “In the value-based U.S. health care system providers tell us they want to improve the clinical process, reduce nursing intervention and optimize patient outcomes. This new device, developed along with our partner sites, allows them to accomplish all three of these objectives. We are thrilled to offer patients and clinicians this state-of-the-art advancement in cancer care.”

DigniCap Delta uses solid state cooling for precise temperature control in an advanced and redesigned model of the 2015 FDA cleared DigniCap Scalp Cooling System. The new device delivers significant improvements over other scalp cooling systems on the market, states the company in their press release.

Delivery to customers will begin in July

DigniCap Delta is now available to medical centers in the United States and delivery to customers will begin in July. The current DigniCap device is already in use in 30 states in the U.S. and in 37 markets globally. The addition of a disposable cap for single patient use provides a new global revenue stream for the company. Existing revenue comes from leasing fees, treatment fees to patients, service agreements and machine sales outside the United States.