Medical Device

Sanuwave Health announced the FDA ruled its decision to allow the marketing of the dermaPACE System as a Class II medical device used for the treatment of Diabetic Foot Ulcers in the US.

Sanuwave Health (OTCQB:SNWV) announced the US Food and Drug Administration (FDA) ruled its decision to allow the marketing of the dermaPACE System as a Class II medical device used for the treatment of Diabetic Foot Ulcers (DFU) in the US.

As quoted in the press release:

This order by FDA is the culmination of intensive clinical studies by SANUWAVE and diligent work by both SANUWAVE employees and our regulatory partners, Musculoskeletal Clinical Regulatory Advisers (MCRA) in successfully submitting documentation and interacting with FDA during the clearance process.
The dermaPACE system was evaluated using two studies under an FDA approved IDE. The studies were designed as prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center 24-week studies at 39 centers. A total of 336 subjects were enrolled and treated with either active dermaPACE plus conventional therapy or sham dermaPACE plus conventional therapy (a.k.a. standard of care). Conventional therapy included, but was not limited to, debridement, saline-moistened gauze, and pressure reducing footwear. The objective of the studies was to compare the safety and efficacy of the dermaPACE System to sham-control application.

Click here to read the full press release.

Source: globenewswire.com

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