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Shockwave Prepares For FDA Approval Of Coronary Intravascular Lithotripsy System

 
• By Reed Miller

The company expects the FDA to approve its intravascular lithotripsy system with the C2 coronary catheter in early 2021 based on results from the Disrupt CAD III study.

• Source: Shockwave Medical (Scott Shadiow)

Shockwave Medical, Inc. is preparing to launch its coronary intravascular lithotripsy system in the US in early 2021, supported by a US field team of over 100 people.

Shockwave’s lithotripsy technology combines an angioplasty balloon catheter with sonic pressure wave emitters to disrupt heavily calcified vascular plaques. The peripheral intravascular lithotripsy system earned a CE mark in 2015...

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• By Elizabeth Orr

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New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
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• By Marion Webb

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Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
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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

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

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.