ARVIS® 510(k) Clearance 

Insight Medical Systems gained 510(k) clearance from the FDA for its flagship product, ARVIS® (Augmented Reality Visualization and Information System). This is the first wearable surgical navigation system to be cleared for both hip and knee arthroplasty. ARVIS combines tracking cameras with both a 3D display and handsfree interface in an integrated eyepiece for total joint arthroplasty. Unlike other augmented reality (AR) platforms, ARVIS is the first system with proprietary hardware designed to assist arthroplasty surgeons in enhancing component positioning precision to improve joint arthroplasty outcomes.

“Developing our own hardware allowed us to make a system that’s optimized for arthroplasty surgeons and to avoid the compromises that come with adapting off the shelf augmented reality glasses,” said Jonathan Nielsen, VP of R&D at Insight.

“This is an important milestone for Insight. We are excited to move forward with commercializing ARVIS with our partner DJO and to bring the benefits of augmented reality to hip and knee surgeons without the typical cost and complexity,” said Nick van der Walt, CEO of Insight.

In March of 2021, DJO® announced a strategic investment in Insight Medical Systems to support DJO’s commitment to the growing computer-assisted surgery market. ARVIS® complements DJO’s ASC 360™ solutions and adds to their full range of implant solutions, surgical tools, and digital care solutions that uniquely span the continuum of care, well positioning DJO as a leader in the rapidly expanding ASC setting.