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FDA approves marketing of Dermapace System for diabetic foot ulcers

January 2, 2018

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The US Food and Drug Administration (FDA) has granted approval to Sanuwave for the marketing of the Dermapace System designed to treat diabetic foot ulcers.

The external shock wave device is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring less than 16cm² that extends through to the epidermis, dermis, tendon, or capsule, without bone exposure.

The device uses pulses of energy, which is similar to sound waves, to mechanically stimulate the wound.

Read More on medicaldevice-network.com