Vuzix M400 Smart Glasses Certified for Knee Replacement Surgery

Startup Pixee using computer vision, deep learning and augmented reality to aid surgeons.

Vuzix M400 Smart Glasses. (Image courtesy of Vuzix.)

Vuzix M400 Smart Glasses. (Image courtesy of Vuzix.)

Computer-assisted surgery (CAS) involves the use of a surgical navigation system guided by special instruments and computed tomography scans of patient-specific anatomy. The system provides feedback to surgeons who oversee the operation.

Vuzix is an optical company founded in 1997 that designs, manufactures and markets their waveguide and Smart Glasses products. Their products are monocular or binocular display systems that are highly customizable.

Recently, France-based startup Pixee Medical began using the Vuzix M400 Smart Glasses to create a computer-aided system to help surgeons perform knee replacement surgeries. The company was successfully funded with USD 2.7 million and won the last French I-Nov contest, receiving a grant of about 1.3 million.

Pixee’s Knee Replacement System with Vuzix M400 Smart Glasses

Pixee Medical’s system, called Knee+, utilizes a mixture of computer vision and deep learning algorithms to help the Vuzix M400 Smart Glasses track implants and instruments during surgical procedures. Robotics are often used in similar procedures, but they take up a lot of space and require preoperative Digital Imaging and Communications in Medicine (DICOM) standards that can amount to additional time-consuming daily tasks for surgeons. Robotic instruments used in computer-aided surgery are also very expensive.

Pixee Medical just received their Conformitè Europëenne (CE) marking certification for Knee+, meaning they took a big step forward into making their knee replacement CAS system a reality for surgeons in the operation room. The CE Mark is the European Union’s mandatory conformity marking for regulating goods sold in the European Economic Area (EEA).

Bottom Line

Computer-Aided Surgery helps surgeons (typically on minor surgeries) by augmenting their ability to see in real-time where instrumentation is relative to the patient’s anatomy. In another boost for Pixee Medical, they were granted ISO 13485:2016 certification.

The next step is to receive FDA approval for Knee+, which Pixee Medical and Vuzix are hoping for by the end of this year.