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March 7, 2017

First FDA clearance for robotic guidance system for dental implant procedures

Miami based Neocis has received FDA 510(k) clearance to market Yomi, a robotic guidance system for dental implant procedures. Yomi is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery, according to a Neocis press release. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

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The surgical robotics market is growing significantly across several medical markets and is estimated to reach $20 billion by 2021. Yomi is the only surgical robotic system focused on the dental industry an is as such the first of is kind, the company states. Neocis is a privately held company focused on improving health care through robotic assistance, It’s  venture-backed, including funding from Mithril Capital and robotic surgery industry pioneer Fred Moll.

Dental implant surgery is the standard of care for replacing missing teeth. Nearly 4 million implants are placed annually in the United States by 15,000 dental specialists and nearly 150,000 general practice dentists. More than 15 million implants are placed annually worldwide.

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Yomi delivers physical guidance through the use of haptic robotic technology, which constrains the drill in position, orientation, and depth. This assistive technology leaves the surgeon in control at all times. Unlike plastic surgical guides, Yomi allows for clear visualization of the surgical site and does not require custom manufacturing. Yomi also provides flexibility during the surgery by allowing the surgeon to dynamically change the plan.

Free-hand implants

"Yomi is a precision instrument that makes sure your implant goes exactly where you planned to put it," said Dr. Jeffrey Ganeles, D.M.D., periodontist at South Florida Center for Periodontics and Implant Dentistry and founding faculty at Nova Southeastern College of Dental Medicine. "I’ve done thousands of implants free-hand. Yomi will be a game changer for dental implant surgery."

Dr. Federico Grande, D.D.S., M.D., an oral surgeon with the Center for Specialized Dentistry, discussed the benefits to his practice and his patients. “Showing my patients the benefits of robotic guidance with Yomi gives them comfort. They know they are getting state-of-the-art treatment and reliable results.”

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