The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler.

The granting of emergency use authorization by the U.S. FDA to Roche AG for its four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and respiratory syncytial virus will allow the company to quickly bring the test to near-patient care environments ahead of the flu season, to address a real need in the marketplace, Ian Parfrement, head of the point of care customer area, at Roche Diagnostics, told BioWorld.

The U.S. FDA is keen to develop tools for oversight of artificial intelligence (AI) as demonstrated by a batch of research projects designed to inform the review of medical applications of AI. The agency’s concern is that there is a dearth of “robust evaluation methods” for evaluating AI products, thus the need for tools that will allow the agency to clear or approve such products with an assurance that these algorithms are safe and effective for their intended use.

The U.S. National Institutes of Health has jumped into the artificial intelligence pool with a prognostic that predicts a patient’s response to immune checkpoint inhibitors as cancer therapies.

Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.

Dublin-based Medtronic plc. has issued an urgent device correction letter to customers using the company’s Stealthstation robotic surgical system due to a software error that may provide inaccurate information about the location of the system’s surgical tip in the cranial anatomy.

Amber Implants BV reported promising results from the first-in-human trial of patients fitted with its Vcfix spinal system which treats vertebral compression fractures. Data showed that patients experienced significant pain relief and regained the ability to walk without discomfort.

As renal denervation (RDN) makes a comeback for treatment-resistant hypertension, Deepqure Inc. is advancing its RDN medical device dubbed Hyperqure with the U.S. FDA granting clearance for a U.S.-based study.

The U.S. appeals court for the District of Columbia has reversed a lower court’s ruling that the device industry cannot appeal a Library of Congress rule that allows third-party access to the software used to govern the operations of medical devices. While the latest outcome in this controversy is a win for device makers, the trajectory of this case is anything but certain as the next step may be an en banc hearing at the circuit court or an appeal to the U.S. Supreme Court.