Zimmer Biomet, Canary Medical Win FDA De Novo For First Smart Knee Implant

Zimmer Biomet and Canary Medical’s FDA de novo clearance of the Persona IQ total knee implant intensifies Zimmer Biomet’s focus on data collection and analytics across continuum of care to improve outcomes and surgery methods, an analyst wrote.

Zimmer Biomet’s Persona-IQ smart implant

Zimmer Biomet Holdings, Inc. and its partner Canary Medical announced on 30 August that the US Food and Drug Administration cleared a de novo application for their Persona IQ implant, the first implantable smart device for total knee replacement that uses sensor-based technology to provide real-world post-surgical patient data for the care team and patients.

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Staff Cuts At CDRH Focus On Administrative Workers, Spare Reviewers

 

About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.

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First At-Home Test For Multiple STIs Gets FDA Clearance

 
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The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.

LDT Saga Comes To A Grinding Halt As Judge Sides With Labs, Vacates FDA’s Final Rule

 

A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.

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