With a major product approval and launch in its sights, Dexcom prepares for a big year in 2022. Across 2021, Dexcom (NSDQ:DXCM) took several steps forward. The company touted its next-generation G7 continuous glucose monitor (CGM) and announced a significant regulatory nod and partnership for real-time application programming interfaces (APIs), to list a couple. As […]
Medtronic
Medtronic CEO confirms FDA warning could affect approval timing for next-gen diabetes tech
An FDA warning over Medtronic’s (NYSE:MDT) diabetes business introduces uncertainty into new approvals, the company’s CEO said. Last month, Medtronic received an FDA warning letter highlighting inadequacies in specific medical device quality system requirements at its diabetes business’ Northridge, California, facility. Today at the 40th Annual J.P. Morgan Healthcare Conference, CEO Geoff Martha said there […]
Hugo, renal denervation and diabetes businesses to drive growth despite setbacks, Medtronic CEO says
Although three major pipelines at Medtronic (NYSE:MDT) have hit recent speed bumps, CEO Geoff Martha reiterated his belief that they will be major growth factors. In October, the medtech giant announced that the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension would continue into next year after lacking the positive results needed to end enrollment […]
Zacks says Medtronic will gain from expanded CMS coverage for CGMs
Zacks Equity Research today reported that Medtronic (NYSE:MDT) stands to gain from yesterday’s CMS coverage expansion for diabetes technology. CMS’s expanded coverage, confirmed by Medtronic yesterday, covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs. The coverage includes CGMs that integrate with Medtronic insulin pumps. Zacks said the new rule will likely […]
CMS expands Medicare coverage to CGMs that integrate with Medtronic insulin pumps
Medtronic (NYSE:MDT) announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) will expand coverage for CGMs. CMS’ expanded coverage covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs, and it notably covers CGMs that integrate with Medtronic insulin pumps. According to a news release, the proposed rule was […]
12 of medtech’s biggest personnel changes in 2021
As medtech companies continued to drive innovation throughout the past 12 months, a number of high-level executives led the way. Some of those companies and those executives opted for major changes over the course of 2021, though, with some high-profile moves from medtech giant to medtech giant. Here are some of the biggest personnel moves […]
Medtronic Diabetes receives FDA warning over quality system requirement inadequacies
Medtronic (NYSE:MDT) announced today that it received an FDA warning letter after an inspection of its Diabetes Business. The company received the letter on Dec. 9 for its Northridge, California facility — the Medtronic Diabetes Business headquarters — following an inspection that concluded in July 2021. FDA’s warning letter to Medtronic focused on the inadequacy […]
Former pediatric endocrinologist joins Medtronic’s diabetes business as medical affairs director
Medtronic (NYSE:MDT) announced this week that former pediatric endocrinologist Dr. Jennifer McVean has joined its diabetes business. McVean, a former pediatric endocrinologist for the University of Minnesota Physicians and an associate professor in the pediatrics department at the University of Minnesota Medical School, will take up a role aimed at augmenting Medtronic’s commitment to providing […]
Medtronic plans to bring next-gen diabetes tech to FDA this fiscal year, no spinoff planned
Medtronic (NYSE:MDT) confirmed that it anticipates major regulatory steps for its next-generation insulin pump and sensor during this fiscal year. Medtronic’s fiscal years wrap up at the end of April. Speaking on the company’s second-quarter earnings call, Chair & CEO Geoff Martha said Medtronic expects its MiniMed 780G insulin pump system with the Guardian 4 […]
How some diabetes tech companies are honoring National Diabetes Month
World Diabetes Day (Nov. 14) may have passed, but it remains National Diabetes Month through the end of November. A number of companies developing some of the most intriguing innovations in diabetes care have also stepped forward this month to organize awareness-raising efforts for the metabolic disease. Here are some steps a handful of diabetes […]
