With FDA clearance, SoftSmile can market its Vision aligner treatment planning software directly to orthodontists.
SoftSmile announced that its Vision treatment planning software was cleared by the U.S. Food and Drug Administration under a 510(k) pre-market notification.
Vision is an end-to-end treatment planner that gives orthodontists the ability to create precise aligner treatment plans that can be manufactured through 3D printing.
SoftSmile is currently working with aligner manufacturers, and the FDA clearance will allow the company to begin marketing it directly to doctors as a standalone application.
“FDA clearance is a huge step for SoftSmile because it establishes Vision’s position as a leading software service that complies with all requirements imposed by FDA and is safe for use in the medical practice,” said Khamzat Asabaev, founder and chief executive officer of SoftSmile.
Vision features automated segmentation and comprehensive staging. The software automatically generates critical aspects of a digital treatment plan.
“It took nearly 18 months, enormous resources, and the coordinated efforts of our engineers and lawyers to be granted FDA clearance,” said Asabaev. “Fortunately, we have only the best at SoftSmile, which has now been given the FDA’s stamp of approval.”
Image courtesy of SoftSmile