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Hypothermia Device Companies Continue To Wage Cold War

For therapeutic hypothermia device companies, the clinical trials that came before have been inconclusive, but they have provided insights to incorporate into the development of next-generation technologies. START-UP interviews two hypothermia device companies with novel approaches: Thermocure and ThermopeutiX.

At the Transcatheter Cardiovascular Therapy (TCT) conference in late October results of the large heart attack trial CHILL-MI were presented. The trial was characteristic of past studies in therapeutic hypothermia: it failed to meet its primary endpoint but it validated the promise of the therapy and advanced the knowledge base, and as such was typical of the halting but forward progress in the field.

The study’s principal investigator, David Erlinge, MD, PhD, the head of the department of cardiology at Lund University in Lund,...

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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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Medtronic, Philips Cement New Pact To Embed Next-Gen Tech In Monitoring Platforms

 
• By Shubham Singh

Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
• By Marion Webb

Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By Elizabeth Orr

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.