The U.S. Food and Drug Administration says Medtronic's diabetes business is back in compliance.
The agency issued a warning letter in December 2021 that detailed concerns about how Medtronic handled recalls and complaints over some of its insulin pumps.
However, Medtronic said late Tuesday all regulatory restrictions associated with the letter are resolved.
The news came after the agency on Friday approved Medtronic's MiniMed 780G insulin pump. The warning letter — and related restrictions — delayed approval for Medtronic diabetes devices. The FDA recently re-inspected Medtronic's facility in Northridge, Calif., where the diabetes business is based.
"We're very thankful to the agency for working with us so collaboratively," said Que Dallara, president of Medtronic Diabetes, in a statement.
Diabetes is Medtronic's smallest business line. It accounted for $2.3 billion of revenue for the company's fiscal 2022, or 7.4% of the company's overall sales. However, Medtronic CEO Geoff Martha is bullish about the diabetes business in the long term.
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