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Business and Technology Briefs

Brief summaries of recent product and company developments in the device industry, including: developments in cardiac stenting, DES competition heats up as the market stabilizes, and headaches for neuro device companies.

Adding fuel to recent concerns about the cost effectiveness, safety, and off-label use of drug-eluting stents (DES) (see "Stent Recap: Turmoil in 2007—What’s Ahead for Interventional Cardiology," Medtech Insight, November/December 2007 Also see "Stent Recap: Turmoil in 2007--What's Ahead for Interventional Cardiology?" - Medtech Insight, 1 November, 2007. ), a new study from University at Albany, State University of New York researchers questions the use of DES in multivessel disease.

The observational study, published in the January 24, 2008 issue of the New England Journal of Medicine, compared DES 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.

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• By Ryan Nelson

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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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‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.