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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 15 panelists determined that the valve—which is implanted with a...

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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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Edwards Lifesciences Holds 2025 EPS Outlook Despite Tariff Headwind

 
• By Shubham Singh

The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.