The U.S. FDA announced several new and updated recalls recently, including a new recall of incubators made by Wipro GE Health Pvt. Ltd., of Bangalore, India, which may be subject to an increased risk that the infant may fall out of the system.

Three U.S. federal government agencies announced that their focus on consolidation in health care markets may soon ramp up, given concerns that consolidation may be affecting the cost and quality of patient care.

Medtronic plc and Irvine, Calif.-based Axonics Inc. have been locked in a struggle over several patents in the past few years, but now Medtronic has shifted some of its effort from the U.S. courts to the executive branch.

The U.S. FDA has proposed an update to an existing program for user fee reductions for companies grossing less than $100 million, although this latest update is much stingier than that. The update would provide registration fee relief for entities with revenues of $1 million or less, but only if that business is in bankruptcy proceedings, a meager bit of relief considering that registration fees in fiscal 2024 run to less than $7,700.

The U.S. FDA reported Feb. 29 that data on the Hintermann series H3 total ankle system suggest a significantly higher rate of device failure than seen in premarket clinical studies, a problem that has arisen even though only five years have passed since the agency approved the device.

The COVID-19 pandemic is well known for increasing telehealth utilization, including remote patient monitoring, but there are still issues with payer coverage policies even a year after the formal end of the public health emergency for COVID.

The U.S. National Institutes of Health reported the launch of a network for clinical trials that will examine the utility of cancer screening tools, which will start with a pilot study of multi-cancer detection (MCD) tests.

The U.S. Patent and Trademark Office (PTO) has released a guidance to aid patent examiners in dealing with questions of obviousness in patent applications, but patent attorney Michael Borella told BioWorld that this new guidance could resurrect the law of unintended consequences. Borella, a partner in the Chicago office of McDonnell Boehnen Hulburt & Berghoff LLP, said the guidance might lead to more inappropriate rejections of patent claims for obviousness, and thus make the process of obtaining a clean patent more difficult, not less.

The U.S. Department of Justice (DOJ) has released the metrics for prosecutions under the False Claims Act (FCA) for fiscal year 2023, ringing up recoveries of nearly $2.7 billion, the 15th consecutive year in which recoveries exceeded $2 billion.

The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is much broader than merely evolutionary software and iterative device designs.