FDA Approves Yomi, the First Dental Robotic Navigation System, Praised by Surgeons

VCBeat has learned that Neocis, a developer of robotic medical devices, recently announced that its Yomi robotic navigation system has received FDA 510(k) clearance for use in dental implant surgery. This marks the first assisted system to gain FDA approval for such applications.

Neocis is a privately held company headquartered in Miami, Florida. Founded in 2012, it secured $1.32 million in Series A financing in August 2014. Its core product is Yomi, a computer-assisted navigation system designed to assist surgeons with preoperative planning and intraoperative guidance for dental implant procedures.

The Yomi Robotic System can accurately set up surgical procedures and provide physicians with a visual interface.

The system operates via haptic robotic technology to provide navigational guidance for surgical instruments, constraining the drill in terms of direction and depth. Haptic robotic technology offers physical guidance on the drill’s position, orientation, and depth. Unlike plastic surgical guides, Yomi enables physicians to visualize the surgical site and provides the flexibility to adjust plans in real time during the procedure.

When used by dentists, Yomi formulates surgical procedures based on the patient’s CT scans. During surgery, the system continuously tracks the patient and precisely controls the direction of the drill bit as the clinician advances it into the tissue, ensuring no deviation from the planned position and depth.

Dental implant surgery is the standard of care for replacing missing teeth. In the United States, 15,000 dental specialists and nearly 150,000 general dentists perform approximately 4 million implant procedures annually. Worldwide, more than 15 million implants are placed each year. Clearly, the surgical robotics market is experiencing rapid growth with substantial demand, and was estimated to reach $20 billion by 2021. Yomi, the only surgical robotic system focused on the dental industry, holds immense promise.

Following FDA approval, Alon Mozes, co-founder of Neocis, stated, “We are thrilled that Yomi has achieved this significant milestone. Our next step is to demonstrate the benefits and convenience of the system to more surgeons and patients, and to secure endorsements from key opinion leaders in the dental industry.” VCBeat has learned that Dr. Federico Grande, a U.S. dental professional, has expressed willingness to showcase the system’s reliability to his patients, encouraging them to try this state-of-the-art approach to dental implantation, while also emphasizing the high reliability of surgical outcomes.