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FDA Panel Vote on Valve Disappoints Emphasys

Nearly a decade into the race to arm pulmonologists with interventional tools to treat emphysema, no clear winner is emerging. Emphasys, which had led the pack in developing a bronchial valve, hit a wall at the FDA. The question is whether competitors can fill the gap.

Necessity may indeed be the mother of invention, but Emphasys Medical Inc. learned this month it’s not going to buy you a break with the Food & Drug Administration. An FDA review panel shocked the company and surprised competitors by voting not to recommend approval for Emphasys' Zephyr Endobronchial Valve. The negative vote—which typically is heeded by the full FDA--took down the leader of the pack of start-ups developing and testing devices to provide comfort for people suffering from the severest forms of emphysema. (See "Devices Fill The Lung Space," START-UP, January 2006 Also see "Devices Fill The Lung Space " - Medtech Insight, 1 January, 2006..)

Even though Emphasys’ product might have provided some relief to people suffering from the crippling pulmonary disease, 13 of the...

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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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Execs On The Move: 2-6 June 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Ellipsis Raises $45M To Expand AI Care Manager Across Health Systems

 
• By Marion Webb

Ellipsis said it will use its new funding to expand its AI-powered voice assistant Sage across health systems. Ellipsis is part of the global vocal biomarker market, which is expected to exceed $9bn by the end of 2033, according to a research market report.

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.