We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Yet another headache has arisen for Philips over the recall of its continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices in the form of a class-action lawsuit filed by durable medical equipment (DME) device suppliers. Read More
The medical device industry finds the FDA’s draft guidance on reporting medical device and diagnostic shortages during public health emergencies (PHEs) too far-reaching and too burdensome. Read More
Medtronic was sued Tuesday by the widow of a type 2 diabetes patient who alleges his death was caused by the company’s MiniMed 630G insulin infusion pump. Read More
The FDA has launched an initiative to strengthen the device supply chain against future disruptions like those caused by the current pandemic. Read More
The FDA issued a warning yesterday about the risk of false results from noninvasive prenatal screening (NIPS) tests, also known as cell-free DNA tests or noninvasive prenatal tests. Read More
Frisco, Tex.-based InspectIR Systems has gained the FDA’s first Emergency Use Authorization (EUA) for an affordable breath-based diagnostic test for COVID-19 infection, and other companies are working on similar analyzers for the pandemic disease. Read More
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
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