1. Medtech Insight
  2. >>Archive

Device Firms Should Not Ignore Pharma Off-Label Suits, Experts Say

While recent case law that appears to give industry more leverage in off-label communications involves drugs, the precedent should apply equally to devices, attorneys say. Nonetheless, companies should be cautious about moving full-steam ahead with off-label promotions

Medical device manufacturers should also benefit from a recent federal court decision saying drug manufacturers have a First Amendment right to make some truthful off-label claims in marketing, attorneys affirm.

In August, the U.S. District Court for the Southern District of New York ruled that Amarin Development AB could...

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

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.

Harbinger Health Showcases Two-Tiered MCED Test With Strong Specificity And Per-Cancer Accuracy

 
• By Shubham Singh

With a test platform designed to mirror the biological diversity of cancer, Harbinger Health is moving beyond traditional performance measures to introduce cancer-specific sensitivity and “intrinsic accuracy” as cornerstones of its clinical narrative.

Veterinary Heart Health Goes High-Tech: Eko And Boehringer Use AI To Spot Heart Murmurs In Dogs

 
• By Marion Webb

Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.