Regulation
Unomedical’s VariSoft’s insulin infusion hit with FDA Class I recall tag
Damage to the device during manufacturing means the connector might detach, stopping insulin delivery and possibly causing hypoglycaemia.
AI in healthcare regulation
FDA creates new advisory committee for digital health and AI
FDA tags Mallinckrodt’s one-way valve recall as Class I
MHRA adds three UK Approved Bodies to its roster
Draeger’s ventilators with contaminated breathing gas in Class I recall
