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FDA Approves CVRx’s Barostim Neo For Heart Failure On Expedited Pathway

 
• By Reed Miller

The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.

FDA approved background, 3D rendering, blue street sign
• Source: shutterstock.com

The US Food and Drug Administration approved an original PMA for CVRx Inc.’s Barostim Neo baroreflex activation therapy device to treat heart failure based on results from the BeAT HF trial.

Barostim Neo is a pulse generator implanted below the collar bone and a lead connected to the carotid artery. It delivers electrical impulses to the baroreceptors in the carotid sinus...

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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.

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• By Vibha Sharma

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