Neocis Announces New FDA 510(k) Clearance for Yomi® to Enhance CT Scanner Compatibility

Tuesday, 12. May 2020 21:00

MIAMI, May 12, 2020 (GLOBE NEWSWIRE) -- Neocis, Inc., the leader and innovator in dental implant surgery using advanced robotics, today announced a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new component for use with Yomi. This component reduces the CT scanner field-of-view (FOV) requirements, which broadens the target market for adopting robot-assisted dental surgery.

Yomi, the first and only FDA cleared robot-assisted dental surgery system, provides robot-assisted guidance relative to a pre-operative plan based on a CT scan. Many dental offices have in-office cone beam CT scanners, which provide a true 3D visualization of the patient as compared to a 2D x-ray or projected panoramic scan. The Yomi system is compatible with all DICOM format CT scans, which includes most scanners on the market. CT scanners vary in the field-of-view that they offer. With the latest clearance, Yomi will be compatible with a wider variety of scanners across a larger range of fields-of-view.

"Increasing the compatibility of Yomi enables us to reach a wider market of implant surgeons,” said Alon Mozes, PhD, Chief Executive Officer of Neocis. “As we continue to improve the technology and the workflow, we’re excited to get this into the hands of more dental implant surgeons so they can benefit from the use of robot-assisted technology.”

Dr. Arthur Lyford, a Yomi user and practicing dentist in New Hampshire, says, “Yomi continues to get easier to incorporate into my practice. I use it for every dental implant. This latest development will make the workflow even easier and provide an opportunity for any dentist with a CT scanner to adopt this state-of-the-art technology."

About Yomi
Yomi® is the first and only FDA cleared robot-assisted dental surgery system. It is indicated for use to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. Yomi provides computerized navigation to assist in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system offers physical guidance through haptic robotic technology, which constrains the drill in position, orientation, and depth. The assistive technology provides the surgeon with complete control and, unlike plastic surgical guides, allows for clear visualization of the surgical site. Yomi® enables a minimally invasive flapless approach, which has been proven to lead to faster surgery, faster recovery, and less pain for the patient. The Yomi Robotics system has been used to place over 1000 implants across the United States.

About Neocis, Inc.
Neocis Inc. is a private company located in Miami, Florida that is transforming dental surgery with advanced robotics, with a vision of advancing healthcare through the latest technology. Neocis manufactures and markets Yomi®, the first and only robot-assisted surgical platform for the dental industry. Neocis is venture-backed, including funding from Mithril Capital Management, Norwest Venture Partners and robotic surgery industry pioneer Fred Moll. For more information visit www.Neocis.com.

Contact
Cassie Hallberg
Vice President of Marketing
(732) 688-8839
info@neocis.com

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