CT Makers Pledge To Upgrade Equipment With Radiation Dose Warnings

With government scrutiny on radiation exposure from medical imaging intensifying, computed tomography manufacturers announced a unified plan last week to incorporate radiation dose alerts into their products

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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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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

 
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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

 

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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CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

Commission Needs To Prioritize Devices Agency Above All Else

 

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

Shuren Expects Longer CDRH Review Times

 
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The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.