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Class I VAD Units Recalls Continue From Abbott, Medtronic

 
• By Elizabeth Orr

HeartMate and Medtronic’s HeartWare ventricular assist device platforms have been tagged with class I recalls in the last few weeks based on separate safety issues.

The text Product Recall appearing behind torn brown paper
• Source: Shutterstock

Separate safety issues have lead Medtronic PLC and Abbott Laboratories Inc. to issue class I recalls on ventricular assist device products used to treat heart failure patients in recent weeks. Class I recalls are the most serious type, and indicate there is a risk of serious adverse events or death.

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

 
• By Marion Webb

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

 
• By Elizabeth Orr

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.

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 
• By Brian Bossetta

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Looking Back Towards The Future

 
• By Brian Bossetta

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.

More from Device Area

No Knife, No Burn, Just Bubbles: HistoSonics Hits 90% Tumor Control In #HOPE4Liver Trial, Eyes IPO Timing

 
• By Marion Webb

HistoSonics, which developed a noninvasive technology to destroy tumor cells, reports 90% local tumor control at 12-month follow-up in the #HOPE4Liver Trial. The Edison System, cleared by the US FDA in late 2023, is also being evaluated for kidney and pancreatic tumors. CEO Mike Blue said the medtech is financially secure but watching public markets as it considers an IPO.

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

 
• By Brian Bossetta

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Roche Diagnostics Hit By China Reforms As Q1 Sales Remain Flat

 
• By Shubham Singh

While Roche continues to view China as a strategic growth market, a sharp 23% decline in Chinese diagnostics sales offset gains in other regions and segments. Despite near-term headwinds, Roche is betting on strong instrument placement growth across its Core Lab, Molecular, and Near Patient Care segments to fuel future demand for consumables and services–key components of its long-term medtech strategy.