There is an increased risk that these devices will not provide audible alerts for low or high blood glucose levels. The FDA has ruled that this is a Class I recall, highlighting the safety risks associated with missed alerts.

The Pearl, a new innovation hub in North Carolina, will soon be home to the first training center of its kind. Many of the advanced technologies on hand will be designed by Medtronic.

This problem doesn't just affect imaging staff but all healthcare workers, one organization cautions.

Janmarie Lanzo is charged with conspiracy to violate the Food, Drug, and Cosmetic Act and defraud the FDA, according to the indictment. 

Vendor Centerline Biomedical recently initiated the action, removing certain IOPS (Intra-Operative Positioning System) Guidewires, used in vascular procedures, from the market. 

Founded in 2019 and based in Chicago, the vendor offers a “leading” infrastructure platform for building, refining and deploying large-scale AI models in medical imaging. 

If an individual is at all susceptible to mental unwellness, overuse of a talkative LLM could push him or her over the edge. Maybe literally. 

Lines included in the kits were misassembled and could result in a botched blood transfusion. Due to the risk of serious injury or death, the recall has been designated as Class I.