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Direct Flow Medical Secures CE Mark For TAVR Device

Direct Flow Medical announced Jan. 28 the receipt of a CE mark for its transcatheter aortic heart valve system, to compete with Edwards, Medtronic among others in burgeoning market.

Direct Flow Medical Inc. announced the receipt of a CE mark for its transcatheter aortic heart valve system Jan. 28.

The CE mark is based on results from 33 patients in the DISCOVER trial, in which 97 percent of subjects...

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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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Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By Elizabeth Orr

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

Execs On The Move: 26-30 May 2025

 
• By Medtech Insight Team

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

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.