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Ireland’s Health Products Regulatory Authority is temporarily banning use of Biotest’s RightSign rapid tests for HIV, HCV and HBV distributed in the Irish market. Read More
Spot On Sciences marketed its products for diagnostic testing despite telling the FDA they were intended for research use only, according to a recent warning letter. Read More
Failure to validate equipment and computer software, and not establishing adequate procedures for implementing corrective and preventive actions, landed French devicemaker Eolane Vailhauques an FDA warning letter. Read More
Physicians and hospitals in the U.S. accepted $7.52 billion in payments and ownership and investment interests from the drug and medical device industry in 2015, according to data released by the Centers for Medicare & Medicaid Services. Read More
The Supreme Court has agreed to review a patent-infringement case between Life Technologies and Promega, involving genetic testing technology. Read More
General Medical Company, a maker of devices for excessive sweating, did not keep a record of verbal complaints and had problems with its complaint evaluations, the FDA found during an October 2015 inspection. Read More