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The graft is available in two delivery formats, a standard syringe and a minimally invasive cartridge used with the company’s GraftGun system. Read More
“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement,” said Bram Zuckerman, director of the FDA’s Office of Cardiovascular Devices. Read More
The syringe, which delivers a controlled amount of balanced salt solution to a targeted site, eliminates the need to create a retinotomy – a hole in the retina – to access the subretinal space. Read More
One problem described in the recall, in which parts of the LED display appear dim, was classified as Class II, meaning use of the product may cause temporary or medically reversible adverse health events. Read More
When determining whether to issue an EUA for a multi-analyte respiratory panel that includes SARS-CoV-2, the agency said it considers the clearance or approval status of diagnostics for the other analytes on the panel. Read More