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News We’re Watching – FDA Nixes Neuralink Trials, Layoffs at J&J, Novel Knee Implants

 
• By Hannah Daniel, Reed Miller, and Elizabeth Orr

This week, we learned that the US FDA thinks Elon Musk’s Neuralink brain interface device isn’t ready for human trials.  Additionally, J&J cut about 300 medtech jobs, Stryker launched a knee implant, and Active Implants’ meniscus replacement device made it to the FDA’s advisory panel calendar. 

"News We're Watching" Feature Image
• Source: Medtech Insight

The US Food and Drug Administration rejected Neuralink Corp.’s plans for a human clinical trials of its Link brain interface implant in 2022, according to an investigative report from Reuters.

Over the last four years, Neuralink CEO Elon Musk has repeatedly claimed that the company was ready to start human clinical trials of Link for motor, sensory, visual or neurological...

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More from Regulation

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• By Amanda Maxwell

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.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
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Zika Virus Test Among 4 New FDA Device Classifications

 
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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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More from Policy & Regulation

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.