Neocis Announces FDA 510(k) Clearance for Streamlined, Imageless YomiPlan Go Workflow

MIAMI, June 30, 2022 (GLOBE NEWSWIRE) — Neocis®, manufacturer of Yomi® and the global leader in robot-assisted dental implant surgery, announced today that their latest software offering, YomiPlan Go™, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) after the successful completion of a recent clinical study. This marks the 13th FDA clearance Neocis has received to date.

Yomi, the first and only FDA-cleared robotic system for dental surgery, assists clinicians in both planning and operative phases of dental implant placement via interactive digital planning (using YomiPlan™ software) and robotic guidance of surgical instrumentation, respectively.

YomiPlan Go, which is expected to be commercially available later this summer, is a software-based workflow that allows doctors to directly visualize a patient’s anatomy, set the desired location and angulation of an implant using their drill tip, and then perform an osteotomy under robotic guidance. This mode differs from the platform’s other workflow options (YomiPlan Complete™ and YomiPlan Dynamic™) as it frees clinicians from having to take a CT scan for case planning in YomiPlan, allowing them to get underway with surgery faster.

“This new FDA-cleared workflow demonstrates our commitment to continuous innovation,” said Alon Mozes, Neocis Co-founder and CEO. “We are dedicated to providing all of our partners with versatile solutions that allow them to use Yomi for the wide variety of clinical cases they take on every day.”

YomiPlan Go’s fast, flexible workflow is similar to freehand surgery but offers the enhanced precision and repeatability of robotic assistance. In this mode, Yomi’s guide arm stabilizes the drill, maintains positional and angular precision as the clinician changes bits, and prevents overdrilling. Users can also accurately parallelize multiple fixtures by using the initial implant as a reference point.

“By combining the feel of freehand surgery with the advantages of haptic guidance, YomiPlan Go adds a human touch to robotic implant placement,” said Massachusetts-based general dentist Dr. Sathish Palayam. “It’s as simple as point and place.”

The growing YomiPlan software suite gives dental practices the flexibility to choose a robotic workflow that best fits their needs, so they can perform robot-assisted surgery with minimal disruption to their existing clinical processes and techniques. “We’re thrilled to introduce another innovation that directly resulted from our users’ input,” said Wayne Craig, Chief Commercial Officer at Neocis. “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.”

Neocis continues to advance implant dentistry, having secured more than 40 patents since the company’s founding. Earlier this year, Neocis released its latest software update, YomiPlan 2.3, which includes YomiPlan Dynamic–a CT-based workflow that allows clinicians to plan a case intra-operatively using just a day-of scan.

Yomi is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

Since 2016, Yomi has been helping clinicians around the country plan and place dental implants with a high level of precision and efficiency, so they can operate with confidence, expand their implant practice, and deliver an excellent patient experience. The platform has assisted in the placement of more than 13,000 implants. Visit neocis.com to learn more about Yomi or schedule a hands-on demo.