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FDA Formally Classifies Cardiac Surgery Device, Robotic Arm

 
• By Elizabeth Orr

Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.

A device used in cardiac surgery and a powered-arm prosthesis will both be regulated as moderate-risk, class II devices, US FDA affirmed in a pair of Oct. 17 Federal Register notices.

Both classifications stem from new device types that were previously cleared for market via the de novo process. Manufacturers of...

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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
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The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
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Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

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Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
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Medtech Experts Debate EU Recertification Gridlock

 
• By Amanda Maxwell

Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.