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US Medicare Creates New Code For Theranica’s Headache Device

 
• By Brian Bossetta

Medicare beneficiaries suffering from migraines will soon have access to an innovate drug-free treatment at the touch of their smartphones.

WOMAN WITH MIGRAINE.
• Source: Alamy

In its most recent Level II Healthcare Common Procedure Coding System (HCPCS), the US Centers for Medicare & Medicaid Services (CMS) has established a new code for Nerivio, an electroceutical migraine device treatment from digital therapeutics company Theranica Ltd.

Level II codes are used primarily for products and services, such as ambulance transport, durable medical equipment, prosthetics, orthotics, and...

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• By Amanda Maxwell

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FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
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The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

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EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
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EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

From Imitation To Action: Johns Hopkins Robot Autonomously Performs Key Step In Gallbladder Surgery

 
• By Marion Webb

Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 
• By Malcolm Spicer

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.