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Biosensors International Wins FDA Approval For Drug-Eluting Coronary Stent

 
• By Brian Bossetta

The US agency’s Center for Devices and Radiological Health has granted a PMA to Biosensors International USA for its BioFreedom drug-eluting coronary stent System to treat coronary artery disease.

Coronary Artery Stent
• Source: Shutterstock

Biosensors International USA, which is part of Biosensors International Group, a global manufacturer of devices used during heart surgery and intensive care treatment, has won premarket approval (PMA) for its BioFreedom stent system.

The FDA’s Center for Devices and Radiological Health (CDRH) approved the device, which uses a catheter delivery system and stainless-steel stent coated with Biolimus A9, an immunosuppressant drug also...

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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

 
• By Amanda Maxwell

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More from Policy & Regulation

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

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