The New York Times published an article on Aug. 20 about potential conflicts of interest on the part of Jeff Shuren, former director of the Center for Devices & Radiological Health (CDRH), arguing that Shuren may have failed to recuse himself in matters in which his wife, a regulatory attorney, represented a medical device maker.

The U.S. Government Accountability Office’s report on FDA oversight of medical devices acknowledges that the agency has made strides in its efforts to develop surveillance systems to track adverse events, but there are shortcomings.

The COVID-19 pandemic drove a large volume of in vitro diagnostic test efforts toward the SARS-CoV-2 virus, such as the Biofire respiratory panel by Biofire Diagnostics LLC, of Salt Lake City, a test for which the U.S. FDA released the special controls.

Privacy legislation was passed and implemented in the European Union, but the picture in the U.S. is pockmarked by state legislation, a scenario that raises concerns about a fractured and impracticable compliance regime.

The World Health Organization has had its collective eye on mpox for some time now, but announced August 14 that the prevalence of the disease in Africa raises the epidemic to a public health emergency of international concern, a change in policy driven by the emergence of a novel strain of the pathogen.

Device makers and physicians alike were less than enthused about several features of the draft Medicare inpatient rule for fiscal year 2025, but thanks in part to support from the device industry, the final rule provides a new code that encompasses both left atrial appendage closure and ablation, a change that may reduce spending without dinging sales of these devices.

The U.S. FDA has made clear its expectations of batteries and accessories for automated external defibrillators, but at least one maker of replacement AED batteries seems to have not got the message.

The U.S. Environmental Protection Agency’s rulings on ethylene oxide emissions have drawn the ire of the device industry, but the chemical industry has weighed in as well.

The U.S. FDA warning letter to Globus Medical Inc., highlights some long-running concerns at the agency about medical device reporting practices, but the agency was keen to point to a problem with the company’s complaint trending practices.

The U.S. National Institutes of Health sponsored a study that was designed to establish whether there are any biomarkers that are strongly associated with the constellation of symptoms known as long COVID, but the study shed little light on the question.