As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...

Instructions for Use (IFU), Directions for Use (DFU), and labeling materials are critical in the medical device industry. Imagine is an end-to-end solutions provider, ensuring that these components ...

Shape Memory Medical Inc. announced the first European patient enrollment in the AAA-SHAPE pivotal trial. The patient was ...

Catholic Medical Center (CMC) officially joined HCA Healthcare on February 1. A combination was necessary to preserve the 130 ...

Outset Medical (Nasdaq: OM) announced today that the FDA says it addressed all issues cited in a 2023 warning letter.

Omar Fateh is joined by other lawmakers and University of Minnesota researchers Feb. 12 to denounce federal cuts to research.

Zimmer Biomet is one of the largest global medical device companies in the United States and has a strong presence in the ... Hospitals are increasingly favoring FDA-cleared solutions over off-label ...

During its fourth-quarter earnings call this week, Inspire Medical disclosed that it has become the subject of a civil probe ...

BlueWind Medical, Ltd ., a leader in implantable Tibial NeuroModulation (iTNM) and developer of the Revi ® System, a patient-centric solution for urgency urinary incontinence (UUI), announced today ...

Medical devices that use ML, in part or in whole, to achieve their intended medical purpose are known as machine learning-enabled medical devices (MLMD). "Medical purpose" refers to parts (a) through ...

Experts from the medical devices industry are not quite happy with the Budget as many of their expectations were not met As the Union Budget has been announced, experts from India's medical devices ...