SoftSmile, a medical technology company based in New York, US, and developer of advanced orthodontic software solutions, has announced that its software device, Vision, was cleared by the US Food and Drug Administration (FDA).
SoftSmile’s software Vision is an end-to-end treatment planner made by doctors for doctors. Its user-friendly interface gives doctors the ability to create precise aligner treatment plans which are then manufactured using advanced 3D printing technologies.
SoftSmile has plans to transform the market by offering doctors treatment planning software directly, which makes it possible to offer more options to patients, thereby cutting costs and increasing efficiency. This development clears the way for this software solution with capabilities including, but not limited to, an automated segmentation feature and an intuitive and comprehensive staging. The software automatically generates key aspects of a digitally optimised treatment plan.
“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 CEO of SoftSmile. “There are just a few orthodontic treatment planners that have obtained FDA clearance. SoftSmile’s new status is a ground-breaking assurance for the market because the FDA is the best quality check for doctors and patients. This achievement opens new opportunities for the company and proves that our team can solve any type of challenge. It took nearly 18 months, enormous resources, and the coordinated efforts of our engineers and lawyers to be granted FDA clearance. Fortunately, we have only the best at SoftSmile which has now been given the FDA’s stamp of approval.”
The company is currently working with established aligner manufacturers. With this FDA clearance, the company can start marketing Vision as a standalone application to be used directly by doctors. Vision can also now be used in any practice without a doctor having to go through third-party designers or manufacturers.