Neocis’s robotic-assisted implant surgery software is now cleared by the U.S. Food and Drug Administration.
Robot-assisted dental implant surgery leader Neocis® has announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for its YomiPlan Go™ software. This clearance comes after a clinical study that demonstrated YomiPlan Go’s utility in robotic-assisted implant surgery.
YomiPlan Go interacts directly with Yomi, Neocis’s FDA-cleared robotic system for dental surgery, according to a press release from Neocis. Yomi works in both the planning and operative phases of dental implant placement using both software and direct guidance. The software, YomiPlan Go, is a workflow that visualizes patient anatomy, sets desired location and angulation, and performs osteotomy with robotic guidance. With YomiPlan Go, clinicians do not need to take a CT scan for case planning.
Yomi’s robotic guide arm is able to stabilize the drill without overdrilling, and has a variety of features that are the result of direct feedback from clinicians, according to Chief Commercial Officer at Neocis, Wayne Craig.
“We’re thrilled to introduce another innovation that directly resulted from our users’ input,” Craig said in the press release. “I’ve never been with a company that so closely partners with and listens to its clients to develop innovative, solution-oriented offerings. We’re excited to provide freehand surgeons with a more precise and versatile alternative to this method, without sacrificing speed and clinical efficiency.”
This is the 13th FDA clearance that Neocis has received for its innovations.