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FDA’s ISO Audit Program Chugs Along; May Be Absorbed By IMDRF Single-Audit Initiative

 
• By Shawn M. Schmitt

Thirty manufacturers have used FDA’s ISO 13485 voluntary audit program since the two-year pilot began last June, freeing up scarce agency inspectional resources to be used elsewhere. However, it will likely be eventually absorbed by a pilot Medical Device Single Audit Program currently under development by the International Medical Device Regulators Forum.

A year-old FDA pilot program that gives device manufacturers an opportunity to ward off an agency inspection has proved somewhat popular with firms and has freed up some of the agency’s overstretched inspectional resources.

Since its June 2012 launch, 30 companies have taken advantage of the “Medical Device ISO 13485:2003 Voluntary Audit Report Submission...

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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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Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 
• By Natasha Barrow

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.

SS Innovations’ SSI Mantra 3 Poised To Challenge Da Vinci In Robotic Surgery Market

 
• By Marion Webb

SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By Elizabeth Orr

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.