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Washington Roundup

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence's "The Gray Sheet."

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence's "The Gray Sheet."

The Institute of Medicine (IOM) committee charged with reviewing the US Food and Drug Administration's (FDA's) 510(k) device premarket review program is urging the agency to ditch the 35-year-old program...

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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

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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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 
• By Natasha Barrow

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.

Medtronic Eyes Up to $350M Tariff Hit in FY26, Leans On Cost Controls And Pricing Strategy

 
• By Shubham Singh

Medtronic expects operating profit to grow approximately 7% in fiscal 2026, excluding tariff impacts. If tariffs materialize at the upper end of the projected range, operating profit growth could drop by 2.2 to 3.2 percentage points.