Neocis wins FDA clearance for Yomi S dental robot in pterygoid implant placement

Neocis, the Miami maker of the Yomi dental surgery robot, said in a press release on Oct 29 that the US Food and Drug Administration cleared Yomi S and its YomiPlan planning software through a 510(k) for pterygoid implant placement. The company described it as the first FDA clearance of digitally guided surgery for this procedure. It did not publish the 510(k) number.

Pterygoid implants anchor in dense bone behind the upper molars. According to the release they are 15 to 24 millimetres long and placed at 17 to 45 degree angles, so any drift from the planned path is magnified at the tip. Surgeons use them to avoid a sinus lift and to treat patients whose upper jaw has resorbed. Neocis said it ran a verification and validation programme showing Yomi S keeps its accuracy specification across the workflow, and that human-factors testing found trained dental professionals need no extra robot training beyond the user manual.

The new indication joins single-tooth, multiple-tooth, full-arch and dual-arch cases and guided alveoplasty on the same platform. Neocis says more than 125,000 implants have been placed with Yomi assistance.

MEKAWIRE context: our database records disclosed Neocis rounds of USD 30 million (2019), a USD 72 million Series D (2020), USD 40 million (2022) and USD 20 million (2024), at least USD 162 million in total. Its backers include NVIDIA's NVentures and Intuitive Ventures, the venture arm of the da Vinci maker covered in our surgical robots market explainer. Dental robotics competes on indications rather than new hardware: each clearance on the existing base lets installed robots handle more of a full-arch practice's caseload. What the release leaves open is how many Yomi units are installed and what share of the 125,000 implants were full-arch cases.