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Q&A: FDA’s LDT Inaction Catches Veteran Attorney Off-Guard

 
• By Elizabeth Orr

Industry experts expected the US FDA to swiftly reverse a Trump-administration policy blocking oversight of lab-developed tests. Its inaction has one former agency attorney wondering why.

Interview

Medtech industry experts had predicted the US Food and Drug Administration would reverse the Trump administration’s policy preventing it from regulating

laboratory developed tests (LDT). But eight months after a new administration took the help the policy is still in place...

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Waters’ Purchase Of BD Biosciences & Dx Brings Growth Potential Alongside Trade-Offs

 
• By Marion Webb

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Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 
• By Natasha Barrow

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• By Natasha Barrow

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

More from Device Area

Ochsner Surgeon In ‘The Big Easy’ Eases Patient’s Pain With Skill And Virtual Reality

 
• By Brian Bossetta

A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.

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

 
• By Elizabeth Orr

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.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 
• By Natasha Barrow

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.