SANUWAVE Health, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued its decision on the de novo submission for the dermaPACE® System. Their decision, dated December 28, 2017, permits the marketing of the dermaPACE System as a Class II medical device used for the treatment of Diabetic Foot Ulcers (DFU) in the U.S., the world’s largest medical device market. This order by FDA is the culmination of intensive clinical studies by the company and diligent work by both the company employees and regulatory partners, Musculoskeletal Clinical Regulatory Advisers (MCRA) in successfully submitting documentation and interacting with FDA during the clearance process. The dermaPACE System offers a novel treatment modality for DFUs, delivering shock wave energy in a non-invasive manner. Treatment consists of 4 - 8 short, non-invasive applications over a 2 to 10 week period. Monitoring and standard of care is required thereafter. This non-invasive treatment provides lower patient adverse events compared with other procedures like amputation or skin grafting, and as a result, the dermaPACE System provides a safe and effective option for treating patients with diabetic foot ulcers.