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 company has agreed to acquire Verve Therapeutics for an upfront payment of approximately $1 billion. The total could increase significantly, however, if certain milestones are met. One of Verve's biggest gene therapies has already received the FDA's fast track designation.