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First Duodenoscope Case Delivers $6.6M Verdict Against Olympus

 
• By Elizabeth Orr

The trial was the first related to outbreaks of antibiotic-resistant “superbugs” that were linked to improperly cleaned duodenoscopes.

A Seattle jury has awarded $6.6m to the plaintiffs in the first superbug-related duodenoscope case against device-maker Olympus Corp. to go to trial.

The bulk of the award will go to Virginia Mason Medical Center, but the hospital was ordered to give $1m to the family of Richard Bigler, who was killed by...

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State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

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• By Brian Bossetta

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US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 
• By Amanda Maxwell

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More from Policy & Regulation

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

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.