STAAR Surgical (NASDAQ:STAA) announces that the FDA in a letter dated August 23, 2019, has determined that the company has provided sufficient data to support initiation of a human clinical study in the U.S. of the EVO/EVO+ VISIAN Implantable Collamer Lens for Myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for Myopia with Astigmatism.
FDA also recommended study design modifications, which STAAR plans to incorporate into the investigational plan in a revised submission in the coming month.
Finalizing the Investigational Device Exemption (IDE) with the FDA is an important step towards the future availability of the EVO Visian ICL family of products in the U.S.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.