Dexcom (Nasdaq:DXCM) today announced that it’s raising its 2023 financial guidance following strong first-quarter financial results. Shares of DXCM dipped 3.7% to $119 apiece after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.2%. The San Diego-based continuous glucose monitor […]
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Dexcom G6 picks up coverage expansion in Canada
Dexcom (Nasdaq:DXCM) today said it applauds an expansion of coverage for continuous glucose monitoring (CGM) systems in Canada. The coverage expansion comes through the Non-Insured Health Benefits (NIHB) program. It now enables any client managing diabetes with insulin to access the standard of care. Dexcom said its G6 CGM is now at its most accessible point […]
Humacyte, JDRF to develop biovascular pancreas to treat type 1 diabetes
Humacyte (Nasdaq:HUMA) and JDRF announced today that they entered into a collaboration to develop a biovascular pancreas (BVP). The collaboration aims to advance the development of Humacyte’s BVP product candidate for treating type 1 diabetes. Humacyte designed its BVP to deliver insulin-producing islets using its investigational, tissue-engineered blood vessel. The company calls it the Human […]
MiniMed 780G a ‘monumental improvement,’ Medtronic Diabetes head says
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, multiple studies further supported the platform’s impact on glycemic control and diabetes management outcomes. But, the company […]
Medtronic Diabetes unit fully resolves FDA warning letter
Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters. In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters. The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of […]
Fractyl Health initiates global registry for diabetes reversal treatment
Fractyl Health announced that it initiated its Revita Global Registry Program in Germany to study its diabetes reversal treatment. On April 20, the Ethics Committee of the University of Freiburg (Germany) granted clearance for the initiation of a registry study. The study covers the Revita system in German hospitals. Patients in the registry have inadequately […]
FDA clears basal-only insulin pod for type 2 diabetes from Insulet
Insulet (Nasdaq:PODD) announced today that it received FDA clearance for its Omnipod GO long-acting insulin delivery device. Omnipod GO, which received clearance for people with type 2 diabetes aged 18 or older, covers the basal-only insulin population. The target population typically takes daily injections of long-acting insulin. The first-of-its-kind, standalone, wearable insulin delivery system provides […]
FDA approves next-gen MiniMed 780G insulin pump from Medtronic
Medtronic (NYSE:MDT) announced that it received FDA approval for its MiniMed 780G system with the Guardian 4 sensor. The news — posted in the evening on April 21 — has MDT shares up more than 4% to $89.36 apiece in afternoon trading today. (MassDevice’s MedTech 100 Index is up slightly.) The positive news for the […]
Fresenius Kabi launches single-needle option for extracorporeal photopheresis
Fresenius Kabi announced the availability of a single-needle venous access option for its Amicus extracorporeal photopheresis (ECP) system. The company announced its availability at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT). Fresenius Kabi first launched the Amicus Blue system with online ECP in Europe in 2019 with double-needle venous […]
Orange Biomed unveils at-home A1c test in the U.S.
Orange Biomed announced today that it commenced a U.S. launch as it looks to fill testing gaps for pre-diabetes and diabetes. Seoul, South Korea–based Orange Biomed operates out of Research Triangle Park, North Carolina in the U.S. The company currently has ongoing studies for its OBM rapid A1c test. It designed the glycated hemoglobin analyzer […]
