New Products In Brief

Japanese authority approves St. Jude’s MRI-safe pacemaker and Edwards’ Sapien XT, the first transcatheter aortic valve approved in that country. More new products.

The Japanese Ministry of Health, Labor and Welfare approved St. Jude Medical Inc.’s Accent MRI MRI-compatible pacemaker along with the Tendril MRI lead, the company announced June 27. St. Jude is launching both devices in Japan immediately.

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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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Analysts See Insulet’s Appointment Of Ashley McEvoy As CEO As A Positive Move

 
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Diabetes company Insulet announced that former longtime J&J executive Ashley McEvoy will succeed Jim Hollingshead as president and CEO effective today. Analysts applauded the appointment, noting McEvoy’s strong background in medtech and diabetes.

HRS Released Framework For Afib Center Of Excellence To Improve Outcomes Through Multidisciplinary Care

 
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Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.

Former FDA Head Tells Heart Society To ‘Get Involved’ To Protect Health Innovation

 
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Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.