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US Medicare Add-On Payments Granted To NuVasive, Gore

 
• By Elizabeth Orr

The Medicare hospital inpatient final rule gives new technology add-on payments to just two devices, Ellipse Technologies's Magec spinal bracing and distraction system, and Gore's Excluder iliac branch endoprosthesis. Two other requests were turned down, and another device was not FDA-approved in time.

Only two devices that applied for new-technology bonus US Medicare payments for fiscal year 2017 made the cut in the latest Medicare hospital inpatient final rule.

Of the five devices up for new technology add-on payments in the Centers for Medicare and Medicaid Services' April proposed...

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UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
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An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
• By Elizabeth Orr

The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

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NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
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FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
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Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.