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FDA Clears World’s First and Only Smart Knee Implant

by Jasmine Pennic 08/31/2021 Leave a Comment

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FDA Clears World’s First and Only Smart Knee Implant

What You Should Know:

– Zimmer Biomet Holdings, a global medical technology leader, and Canary Medical, a medical data company, announced U.S. Food and Drug Administration (FDA) De Novo classification grant and authorization to market the tibial extension for Persona IQ®, the world’s first and only smart knee cleared by the FDA for total knee replacement surgery.

– Persona IQ® combines Zimmer Biomet’s proven and trusted knee implant, Persona® The Personalized Knee®, with Canary Medical’s proprietary implantable canturio tetibial extension sensor technology that monitors implant function to inform surgeons and patients of post-surgery progress.

– The knee implants are fitted with a sensor that wirelessly transmits information to a secure cloud server through a base station inside the patient’s home. Key information (e.g., range of motion, step count, walking speed) is then aggregated and analyzed, to provide both patients and doctors a more complete snapshot of recovery progress. Historically, surgeons rely on patients to report on their progress during infrequent follow-up visits conducted in person.

– Persona IQ will be available to healthcare professionals and patients in the coming months.

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Tagged With: FDA, Medical Device

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