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News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants

 
• By Elizabeth Orr and Brian Bossetta

Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.

"News We're Watching" Feature Image
• Source: Medtech Insight

LivaNova PLC has issued a recall of its LifeSPARC Controller, which is part of the LifeSPARC system used to sustain patients during open heart surgeries. The recall includes 589 controllers that were distributed in the US between December 2019 and November 2022.

The US Food and Drug Administration has labelled the recall class I, indicating a high level of risk. It adds to an October recall for the same issue – a...

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