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News We’re Watching: UK Software Guidance, FDA Approvals, Halyard Mask Warning

 
• By Brian Bossetta, Reed Miller, Eliza Slawther, and Hannah Daniel

Abbott landed a surprise US FDA approval for the FreeStyle Libre 3 glucose monitoring system. Also this week: updated guidance documents on software (UK) and angioplasty catheters (US), FDA clearances for Candesant and Moximed, new regulatory requirements for spinal spheres, and a warning on Halyard masks. 

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

The US Food and Drug Administration has approved a new standalone reader device for Abbott’s FreeStyle Libre 3 integrated glucose monitoring system, the company announced on 14 April.

The FreeStyle Libre 3 reader offers an alternative to the FreeStyle Libre smartphone app. It connects to the sensor on the user’s arm and displays glucose readings on a “large,...

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

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

 
• By Elizabeth Orr

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Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.