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A California state appeals court has ruled that Johnson & Johnson (J&J) must pay $302 million in civil penalties in one of the long-running cases against the company and its Ethicon subsidiary over its pelvic mesh products, a reduction from almost $344 million awarded by a lower court.
The California Superior Court ruled Jan. 30, 2020, that J&J engaged in false and deceptive marketing of its pelvic mesh products for women and ordered the company to make the higher payout. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has released a Manual of Policies and Procedures (MAPP) document that explains how the agency will classify complex new drug products and drug-device combination products assigned to CDER. Read More
The Department of Health and Human Services (HHS) has declared that the COVID-19 public health emergency (PHE) will continue for at least three more months, which means devicemakers will need to need to continue to adhere to the many guidances the FDA released that contain pandemic-specific directives. Read More
Cellvizio is now cleared to perform fluorescence imaging of tissues that have taken up indocyanine green or On Target Laboratories’ fluorescent drug Cytalux (pafolacianine). Read More
French diagnostics giant bioMérieux is acquiring San Jose, Calif.-based Specific Diagnostics, a company that has developed a rapid antimicrobial susceptibility test (AST) used to identify and quickly treat patients infected with antimicrobial-resistant pathogens. Read More
The FDA has released two final guidances outlining a new product review pathway for developers of facet-screw systems and denture-base resins. Read More
The AI algorithm helps identify several cardiopulmonary conditions, including chronic obstructive pulmonary disease, pneumonia, asthma and cardiac morbidities. Read More