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Research Briefs: Underreporting Robot Surgery Events; AFib, Lung-Cancer Studies

A review of court records and media reports finds several robotic surgery adverse event reports that do not appear in FDA’s public records. DECAAF shows DE-MRI can guide atrial fibrillation ablation. The PanCan study identifies predictors of lung cancer.

A study comparing the adverse event reports collected by FDA with news reports and court records shows that many robotic-surgery related complications are not reported to the agency. Martin Makary of the Johns Hopkins School of Medicine and colleagues searched the FDA device-related complication database, LexisNexis and PACER (Public Access to Court Electronic Records) to find incidents of robotic surgery-related complications from 2000 through July 2012. They cross-referenced cases mentioned in news articles on LexisNexis and court cases in PACER with adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) to determine if the case was reported accurately to the agency.

Results of the study, published Aug. 27 in the Journal for Healthcare Quality, show that 245 events were reported to...

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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.

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