SoftSmile Secures FDA Clearance for Artificial Intelligence Powered Software VISION

SoftSmile Secures FDA Clearance for Artificial Intelligence Powered Software VISION

Orthodontic software solutions company SoftSmile has announced that its VISION software has received 510(k) US Food and Drug Administration (FDA) clearance. This clearance is indicated for pre-market notification.

VISION touts itself as a treatment planning software powered by artificial intelligence (AI). It is said to feature a user-friendly interface that allows clinicians to design clear aligner treatment plans which can then be 3D printed in the practice. SoftSmile hopes to increase efficiency by way of cutting out the middleman by allowing dental professionals to directly treatment plan and manufacture in the practice, according to Founder and CEO of SoftSmile Khamzat Asabaev.

"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. There are just a few orthodontic treatment planners that have obtained FDA clearance. SoftSmile's new status is a groundbreaking assurance for the market because the FDA is the best quality check for doctors and patients,” Asabaev said in a press release from SoftSmile. “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.”

SoftSmile hopes that VISION will pave the way for automated segmentation and comprehensive staging for treatment planning in the future. VISION is available now for any practice.