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FDA Panel To Address Paclitaxel Safety Concerns

 
• By Elizabeth Orr

The US FDA will soon hold a meeting to discuss paclitaxel-coated devices to treat peripheral arterial disease. The drug-eluting stents and balloons have been subject to increased scrutiny since a meta-analysis found they were linked to a higher patient mortality rate.

FDA Advisory Committee Feature image

The increased scrutiny of paclitaxel-coated devices to treat peripheral arterial disease (PAD) will continue with an upcoming meeting of the US FDA’s coronary devices advisory panel.

The meeting, which the FDA announced in the April 22 Federal Register, will be held in Gaithersburg, Maryland on June...

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More from United States

Experts Call For Database Of Medical Device Labels

 
• By Elizabeth Orr

A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
• By Brian Bossetta

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
• By Elizabeth Orr

US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the

House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 
• By Eileen Francis

The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.

More from North America

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 
• By Natasha Barrow

The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 
• By Brian Bossetta

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

European MedTech Keeps Calm Despite US Threats Of 30% Tariffs

 
• By Amanda Maxwell

MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.