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September 22, 2026
THE LATEST ON THE MEDICAL DEVICE INDUSTRY
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A Preview of MDUFA VI: Changes and Highlights, Part 1—Mike on Medtech

 
Mike on Medtech podcast

Sean Fenske and Mike Drues discuss the next version of the Medical Device User Fee Act and examine what changes may come.
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Mindray Takes Aim at the Philips Void with New Ventilator

Mindray's launch comes as respiratory departments navigate withdrawal of the Philips V60, which has driven fleet replacements in hospitals.

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Lenovo Executive Art Hu Joins BD as Digital Chief

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FDA Clears Traferox’s 10°C Heart Preservation System

Studies have associated 10°C heart preservation with lower rates of severe primary graft dysfunction and improved post-transplant survival.

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Cordis Wins FDA Nod for Selution SLR Sirolimus-Eluting Balloon

The next-gen DEB provides sirolimus therapy for up to 90 days without leaving behind a permanent implant.

Supplier News

maxon Group Announces Leadership Changes

Eugen Elmiger is ending his 15-year tenure as CEO.

People

New Soft Wearable Device Could Support At-Home Sleep Monitoring

New study shows a wireless wearable device could enable home-based monitoring of physiological changes linked to sleep and brain health.

Features

Advancing Automation in Medical Device Manufacturing

Sophisticated tools such as IoT and AI are taking automated systems to the next level, offering opportunities for manufacturers to address labor shortages and the skills gap.