Neocis said yesterday that it received FDA 510(k) clearance for a new robot-assisted drill to be used with its Yomi dental surgery system.
The Miami-based company said the clearance will lead to an easier workflow and provide enhancements to the surgeons’ drilling experience.
Yomi won FDA clearance in March 2017 for dental implant procedures, becoming the first robot-assisted device of its kind. The system is designed to offer physical guidance through haptic robotic technology, controlling the drill in position, orientation and depth. The system is supposed to offer a surgeon complete control and clear visualization of the surgical site.
Neocis announced in July that it raised $30 million for commercialization and R&D for the Yomi system.
“Streamlining the workflow for our robot-assisted surgery system is the most critical part of enabling this technology to be broadly adopted,” CEO Alon Mozes said in prepared remarks. “We are laser focused on creating a great experience for the surgeon and the patient.”
“I am tremendously impressed with the team at Neocis,” added the Arkansas Oral & Facial Surgery Center’s Dr. Scotty Bolding. “They are truly listening to the professionals and continue to advance the robotic technology to make the system more accurate and user friendly. This latest FDA clearance is just another example of how they are making the system easier to use and making Yomi not only routine in our practice, but establishing the standard of care for our patients.”
Original Article: (https://www.massdevice.com/fda-clears-new-drill-for-neocis-yomi-robot-assisted-dental-surgery-device/)