Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.

The U.S. FDA’s effort to regulate lab-developed tests was predictably controversial, but the final rule drew a second lawsuit, this time from the Association for Molecular Pathology.

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.

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. 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The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.

The U.S. FDA’s draft guidance for in vitro diagnostics under a Section 564 public health declaration broke little new conceptual ground, but the Association for Molecular Pathology (AMP) urged the agency to reconsider the COVID-19 experience.

Minneapolis-based Smiths Medical Inc., recalled two entries in the company’s CADD-Solis line of ambulatory infusion pumps due to problems with the preloaded software.