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Rejected Again: Advisory Panel Votes Against De Novo Approval For Tennessee Company’s Knee Implant

 
• By Brian Bossetta

An FDA advisory committee voted against recommending the agency approve a de novo request from Active Implants for its NUsurface Meniscus Implant. The request is the company’s fifth attempt at winning FDA approval.

NUsurface Meniscus Implant
• Source: Active Implants

It’s looking more likely that Active Implants will fail again in getting its knee implant on the US market.

The US Food and Drug Administration’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted 6 to 2 with one abstention against recommending that the agency grant...

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More from Regulation

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.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

More from Policy & Regulation

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.