1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Legislation

Olympus, Pentax Working On Responses To Sen. Murray Duodenoscope Contamination Concerns

 
• By Sue Darcey

Two duodenoscope manufacturers – Olympus and Pentax – this week joined Fujifilm in saying they are aware of Senate HELP Committee ranking member Patty Murray’s concerns about recently released duodenoscope contamination levels and are working to complete postmarket surveillance studies of their devices, as required by the US FDA.

endoscopy
Physician prepares for patient procedure with duodenoscope in hand

Both Olympus Corp. of the Americas and Pentax Medical – duodenoscope-makers who, with Fujifilm, were the target of recent letters from Sen. Patty Murray concerning contamination seen in their products – say they are working with the US Food and Drug Administration to complete postmarket surveillance studies.

Murray, D-WA, is ranking member of the Senate Health, Education, Labor, and

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legislation

More from Policy & Regulation

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.