1. Medtech Insight
  2. >>Archive

US FDA may reclassify PTCA catheters, issues guidance on devices

 
• By Peter Rixon

The FDA’S Circulatory System Device Panel is recommending that percutaneous transluminal coronary angioplasty (PCTA) catheters be reclassified from class III (premarket approvals) to class II (special controls), following a petition made by the Cook Group.

The FDA’S Circulatory System Device Panel is recommending that percutaneous transluminal coronary angioplasty (PCTA) catheters be reclassified from class III (premarket approvals) to class II (special controls), following a petition made by the Cook Group.

A PTCA catheter is a device that operates on the principle of hydraulic pressurisation applied through an inflatable balloon attached...

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 Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

Philips Deals Itself A Strong Hand In POCUS Stakes

 
• By Ashley Yeo

Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 
• By Natasha Barrow

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.