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News We're Watching – 27 January

 
• By Brian Bossetta, Hannah Daniel, and Elizabeth Orr

This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel. 

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

Medtronic plc sent an “urgent medical device correction” letter to customers on 17 January requesting they return some batteries used with the company’s HeartWare Ventricular Assist Device (HVAD) system, which has been subject to numerous recalls.

In June 2021, Medtronic stopped the sale and distribution of the HVAD system, which treats heart failure by supporting the weak left ventricle and providing additional blood flow, because patients...

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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

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FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

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