1. Medtech Insight
  2. >>Archive

Advisory Panel Endorses Boston Scientific’s Watchman Left Atrial Appendage Closure Device

FDA’s Circulatory System Devices advisory panel voted 13-1 to recommend approval of the firm’s PMA for the Watchman device as an alternative to warfarin therapy for stroke prevention in atrial fibrillation patients for whom long-term anticoagulant therapy is too risky.

FDA’s Circulatory System Devices advisory panel overwhelmingly recommended approval of Boston Scientific Corp.’s PMA for the Watchman left atrial appendage (LAA) closure device as an alternative to warfarin therapy for stroke prevention in some atrial fibrillation patients.

Watchman is intended to prevent embolism from the left atrial appendage that could cause stroke, systemic embolism, and cardiovascular death in high risk patients with non-valvular atrial fibrillation for whom...

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

Edwards Lifesciences Holds 2025 EPS Outlook Despite Tariff Headwind

 
• By Shubham Singh

The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

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.