FDA grants 510(K) clearance to Insight’s wearable surgical navigation system
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The FDA granted 510(K) clearance to Insight Medical Systems for its surgical navigation technology ARVIS (Augmented Reality Visualization and Information System).
According to a company press release, ARVIS is the first wearable surgical navigation system to be approved for both hip and knee procedures and is designed to improve component positioning precision in joint arthroplasty.
“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, vice president of research and development at Insight. The FDA approval follows DJO’s March 2021 announcement of their investment in Insight to support their range of surgical tools and digital resources as well as the expanding computer assisted surgery market.
“This is an important milestone for Insight,” said CEO of Insight Nick Van der Walt in the release. “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.”
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