The U.S. Food and Drug Administration has authorized a “smart knee” implant developed by Warsaw-based Zimmer Biomet Holdings Inc. (NYSE: ZBH) and Canary Medical in Canada. Zimmer Biomet says the FDA’s De Novo classification grant allows the companies to bring their Persona IQ device to market.
Zimmer Biomet says Persona IQ combines its Persona knee implant with Canary Medical’s proprietary tibial extension sensor technology, which can measure and determine range of motion, step count, walking speed, and other gait metrics. Once it is implanted in the knee, the company says the device can record and wirelessly transmit the metrics, allowing surgeons to assess post-surgery recovery progress.
The device works with Zimmer Biomet’s mymobility remote care management platform and is part of its ZBEdge connected intelligence suite. Bryan Hanson, chief executive officer of Zimmer Biomet, says the smart knee implant is the first of its kind in the world.
“As the newest component of ZBEdge, Persona IQ advances our vision of creating a seamlessly connected suite of digital health and robotic technologies to deliver objective data to clinicians throughout the surgical journey,” Hanson said in a news release. “Following a recent expansion of our partnership with Canary Medical, we now expect that Persona IQ will be the first in a broader portfolio of smart implant technologies in various orthopedic surgery applications.”
According to Indianapolis-based Greenlight Guru, which works to help medical device companies navigate the global regulatory landscape, the De Novo classification process is another way for companies to receive approval from the FDA to bring low-to-moderate risk devices to market.
Zimmer Biomet says it licensed the sensor technology through an exclusive partnership agreement with Canary Medical. You can learn more about Persona IQ by clicking here.