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ZimVie Wins Investigational Device Exemption For Disc Replacement Device, Plans To Begin Study

 
• By Brian Bossetta

The US FDA has granted Investigational Device Exemption to Colorado life sciences company ZimVie for its cervical disc implant. The approval means the company can begin enrolling patients in a study to further evaluate the device.

ZimVie Mobi-C
• Source: ZimVie

ZimVie announced today that the US Food and Drug Administration has granted Investigational Device Exemption (IDE) for its Mobi-CCervical Disc, which is approved to treat more than one level of the spine.

The IDE approval means ZimVie can begin enrolling participants in a hybrid study following patients who receive simultaneous cervical disc...

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New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

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UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

More from Policy & Regulation

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

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Tarver And Makary Emphasize Commitment To At-Home Healthcare Innovations In FDA Podcast

 
• By Elizabeth Orr

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