It’s been a long road for the Medtronic (NYSE:MDT) Diabetes unit to get its next-generation technology to market.
For years, clinical data backed up the MiniMed 780G insulin pump with Guardian 4 sensor technology. Over the last year alone,
The company hit an initial hiccup with an FDA warning letter related to its California Diabetes facility in 2021. CEO Geoff Martha said early in 2022 that the letter was likely to impact the regulatory timelines for next-generation technology. Meanwhile, analysts were suggesting that the unit was on the spinoff block.
For now, those issues are in the past, though. Medtronic yesterday said it fully resolved the warning letter with the FDA.
Just a few days earlier, Medtronic announced that it received FDA approval for MiniMed 780G with Guardian 4.
The system offers meal detection technology and provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.
MiniMed 780G with Guardian 4 offers insulin to account for when users forget to bolus or underestimate the number of carbs in their meal. It also requires no fingersticks when in SmartGuard mode.
Analysts reacted positively to the news, as Wells Fargo and Barclays upgraded MDT stock. BTIG analyst Ryan Zimmerman isn’t jumping to conclusions too quickly on the impact on Medtronic’s business.
“We think the bigger question is whether this approval provides MDT’s Diabetes business unit with a much needed growth boost and can it lift the entire company closer to MDT’s long-term growth guidance?” he wrote.
Que Dallara, Medtronic Diabetes EVP and president, and Ali Dianaty, VP of product innovation, spoke with Drug Delivery Business News following the landmark regulatory nod.
“We’re thrilled to have 780G approved in the U.S.,” Dallara told DDBN. “At long last and much-anticipated.”
Get the full story at our sister site, Drug Delivery Business News.