Edwards Hits Snags With Trial Of Catheter-Delivered Heart Valve
Edwards Lifesciences is facing enrollment delays in its U.S. pivotal trial of a less invasive heart valve, though the company still says it will complete the patient sign-up effort by the end of next year
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Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.
The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.