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Zimmer Surgical Robot Class I Recall Due To Software Glitch

 
• By Elizabeth Orr

The problem could cause incorrect display of neurological scans that could potentially lead to errors in surgical planning.

Zimmer ROSA One surgical robot in use.
• Source: Zimmer Biomet

Zimmer Biomet Holdings, Inc. is recalling its ROSA One 3.1 Brain Application, a robotic platform designed to help neurosurgeons position medical tools during surgery. The US Food and Drug Administration, which announced the recall on 29 October, has identified the action as a high-risk class I recall.

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Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 
• By Brian Bossetta

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Makary Proposes Combined Adverse Event Reporting Systems In Megyn Kelly Interview

 
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FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 
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The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

One Death Linked To Calyxo Urological System

 
• By Brian Bossetta

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.

More from Policy & Regulation

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.