BioWorld

15 hours ago | bioworld.com

A low-intensity transcranial ultrasound stimulation device, developed by Sonomind SAS, was proven to be safe and effective in treating patients suffering from drug-resistant depression. The results of a study published in Brain Stimulation showed a 61% reduction in the depressive symptoms of patients treated with the device over a five-day period, with no serious adverse events.

1 day ago | bioworld.com | Mark McCarty

Home » Noridian eyes coverage of Invitae test panel for heritable aortic disease BioWorld briefs for May 13, 2025. BioWorld MedTech briefs for May 13, 2025. After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite,... Targeted protein degradation has yet to notch its first approval. But with more than two dozen agents now in clinical trials, the strategy’s ultimate clinical...

1 day ago | bioworld.com | Mark McCarty

FDA warns ICU Medical for fixes for infusion pumpThe U.S. FDA’s April 4, 2025, warning letter to ICU Medical Inc. cited the company for failure to file a new 510(k) for changes to software used in an infusion pump, but those changes may have been driven by problems with the pumps the company acquired when it picked up Smiths Medical in 2022. The FDA also issued a warning letter to Epicare Acquisitions LLC related to its Zenith family of laser hair removal systems.

1 day ago | bioworld.com | Mari Serebrov

Home » US lawmakers call for action in addressing PBM practices BioWorld briefs for May 13, 2025. BioWorld MedTech briefs for May 13, 2025. After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite,... Targeted protein degradation has yet to notch its first approval. But with more than two dozen agents now in clinical trials, the strategy’s ultimate clinical...

1 day ago | bioworld.com | Mari Serebrov

HHS asks for input on which regs to kill As the U.S. Department of Health and Human Services (HHS) and its agencies begin weeding out old regulations, the department is requesting public input to help identify and eliminate outdated or unnecessary regulations. BioWorld BioWorld MedTech Regulatory U.S. FDA Policy