What process did Artefill go through before it was FDA approved?
Artes Medical conducted clinical studies in the United States to demonstrate the safety and effectiveness of our microsphere dermal filler technology. The data from our clinical trials were subject to a full and open review in a public hearing by an FDA review panel. During the review, we worked with the FDA to further enhance our manufacturing process and testing to ensure that ArteFill meets the highest quality standards. ArteFill was approved by the FDA in October 2006 after eight years of clinical study and review.
