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Is there an Engineer in the House?

The recent clinical successes of artificial hearts and VADs knock over the first barrier to adoption of a new, life-saving therapy. But other hurdles remain, including providing the infrastructure to service large numbers of patients going about with extremely complicated, often quirky high-tech implantable devices on which their lives depend. The University of Pittsburgh is marshalling its bioengineering resources into a commercial entity, start-up Vital Engineering, which will be able to provide post-implant services on a wider, even global scale.

The notion that life-supporting organs could one day be replaced by machines is no longer just the stuff of science fiction. Abiomed Inc. 's AbioCor total heart replacement has now been implanted in three patients. Those events, and data from a dramatically successful trial of Thoratec Corp. 's HeartMate VE left ventricular assist device (VAD), point the way to a future in which patients will be able to go about their daily lives with the assistance of implantable devices hidden inside their bodies. Yet clinicians are only now waking up to the need to service these complex devices post-transplant.

The REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart failure) data were gathered in a pivotal...

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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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Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

HistoSonics’ Edison System Gains Limited UK Access, While Awaiting CE Marking

 
• By Shubham Singh

While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
• By Marion Webb, Shubham Singh, and Nancy Pham

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.