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.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), apologized yesterday to the Senate Committee on Health, Education, Labor and Pensions (HELP) for missing the deadline to send the final Medical Device User Fee Amendments (MDUFA) V commitment letter to Congress by the Jan. 15 deadline. Read More
Philips Respironics has received a subpoena from the Department of Justice (DOJ) for documents relating to its recalls of millions of continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices. Read More
Qvella’s Field Activated Sample Treatment (FAST) system recorded similar results to other blood culture diagnostic tests but delivered the results 24 hours sooner, according to a study by researchers in Germany. Read More
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The medical device industry finds the FDA’s draft guidance on reporting medical device and diagnostic shortages during public health emergencies (PHEs) too far-reaching and too burdensome.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