Medtronic: FDA lifts warning letter received at company’s Diabetes headquarters

Medtronic announced that the U.S. FDA lifted the warning letter received at the company’s Diabetes headquarters in Northridge, California, in December 2021. This follows on the heels of last week’s FDA approval of the MiniMed 780G system, the world’s first and only automated insulin delivery system with meal detection technology that provides automatic adjustments and corrections to glucose levels every 5 minutes. The resolution of the warning letter follows ongoing remediation actions from the company and proactive actions to continue to strengthen its quality systems. All regulatory restrictions associated with the warning letter have been resolved.