1. Medtech Insight
  2. >>Archive

Iris International Seeks Reimbursement For Its Prostate Molecular Dx

The firm, soon to be acquired by Danaher, is pursuing a major data collection effort to gain reimbursement for its ultrasensitive prostate cancer assay, following a 300-patient trial to support 510(k) clearance.

IRIS International Inc. says it is collecting clinical data for its NADiA ProsVue prostate cancer molecular diagnostic with hopes of gaining Medicare reimbursement in 2013.

The ultrasensitive prostate specific antigen (PSA) assay gained 510(k) clearance in September 2011 and launched this March for use in men who undergo a radical prostatectomy for prostate

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

LSX Europe: Women’s Health Education Is The Key For Unlocking VC Investment

 
• By Natasha Barrow

Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
• By Marion Webb

Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

 
• By Natasha Barrow

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.