Pulsecath BV has secured CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took us four years and we spent more than €700,000 to get approval under the MDR for the same product that we already had CE mark for under the Medical Device Directive (MDD) for the last 10 years or so,” Oren Malchin, CEO of Pulsecath, told BioWorld.

US Medicare coverage for AI seen as ‘a train wreck’

Medicare coverage of software in the U.S. is generally not the subject of flattering remarks from industry, but the novelty of the subcategory of artificial intelligence (AI) would seem to suggest that the Medicare problem for AI is even more severe. That suspicion was borne out by consultant Bruce Quinn who said at a public meeting here in Washington that some areas of software coverage and reimbursement, including AI software, “are just a train wreck,” a problem he said is especially acute in fee-for-service care.

Wuxi quits BIO in wake of US national security risk allegations

Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.

Nerve growth drives chronic pain after recurrent UTIs

In a recent study led by Soman Abraham from Duke University, investigators observed that an increase in nociceptive sensory nerves in urinary tract biopsies from patients with recurrent urinary tract infections (rUTIs) was linked to elevated nerve growth factor (NGF) from monocytes and mast cells. This overgrowth of nerve cells appeared to cause lingering symptoms after rUTIs. These findings, appearing in the March 1, 2024, online edition of Science Immunology, have the potential to provide a new approach to managing symptoms of rUTIs that would reduce unnecessary antibiotic usage.

Point-of-care brain monitoring algorithm for detecting stroke in children

In what represents their first patenting, a researcher from the University of California is seeking protection for non-invasive methods of brain monitoring that use electroencephalography (EEG) to detect new or worsening brain injury in pediatric patients. Muaro Caffarelli is an assistant professor, pediatric neurologist, and critical care specialist whose focus is hospitalized children who are critically ill or who have had high-risk surgery. Referred to as the Correlate Of Injury to the Nervous system index, the invention is a quantitative EEG metric designed to identify areas of cerebral dysfunction concerning for stroke.

Also in the news

Axonics, Bonesupport, Cosm Medical, Exact Sciences, Fresenius Medical Care, Guardant Health, Gynica, Lifeward, Naveris, Neurometrix, Outset Medical, Oxford Biodynamics, Preludedx, Pulsenmore, Thinksono, Voxeleron