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The FDA granted the designation based on pre-clinical data from its animal studies and clinical data collected in its first in-human feasibility trial. Read More
The company will now launch the test in Europe for use in healthcare settings, including clinics and emergency rooms, and will initiate trials evaluating its over-the-counter use. Read More
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 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
“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