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The software tools allow users to quickly see all their therapy data in one place and also provide in-the-moment diabetes management coaching and feedback. Read More
The test can detect the Delta variant of the SARS-CoV-2 virus first identified in India, which has become the dominant strain in many countries. Read More
The FDA said the blood lead tests “may provide falsely low results and may lead to health risks in special populations, such as young children and pregnant individuals.” Read More
The assay is validated for use with Bio-Rad's CFX96 DX polymerase chain reaction (PCR) instruments, but it can also run on PCR systems made by other companies, Bio-Rad said. Read More
FDA investigators observed a variety of good manufacturing practice deficiencies during four inspections conducted this spring at facilities in New York, California and North Carolina. Read More
An EU expert panel has challenged a notified body’s clinical evaluation report, which is an additional element of conformity assessment for certain high-risk devices under the EU’s Medical Device Regulation (MDR), marking the first such challenge. Read More