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The authorization “provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year,” said Raquel Peat, director of the Center for Devices and Radiological Health’s Office of Orthopedic Devices. Read More
“In light of the COVID-19 pandemic, it is even more important to detect other diseases associated with respiratory disease early on, especially for high-risk patient groups,” said François Lacoste, BioMérieux’s executive vice president of R&D. Read More
“The Jet 7 Xtra Flex catheter “is not able to withstand the same burst pressures” to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus in acute ischemic stroke patients,” the agency said. Read More
The IVD can be used by clinicians to identify breast cancer patients who are most likely to benefit from the approved phosphoinositide 3-kinase targeted therapy. Read More
BD has launched a $1.2 billion program to expand and upgrade its manufacturing capabilities for pre-fillable syringes and advanced drug delivery systems. Read More
“Quantitative antibody testing can help provide greater understanding of a person’s immune response,” said John Hackett, divisional vice president of applied research and technology for Abbott’s diagnostics wing. Read More
The European certification also clears the company’s Motiva Ergonomix2 Diamond breast implant, which will be used with its Motiva Mia minimally invasive breast augmentation system when it is approved. Read More
“As the flu season overlaps with the second wave of COVID-19, there is an increasing need to be able to quickly distinguish between SARS-CoV-2 and influenza infections,” said Wolfgang Schlumberger, CEO of Euroimmun. Read More