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Sean Whooley

Dexcom grows revenues 18% in Street-beating Q1, raises guidance

April 27, 2023 By Sean Whooley

Dexcom updated logo

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Patient Monitoring, Technology, Wall Street Beat Tagged With: Dexcom

Dexcom G6 picks up coverage expansion in Canada

April 27, 2023 By Sean Whooley

Dexcom G6 in action

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: Dexcom

Humacyte, JDRF to develop biovascular pancreas to treat type 1 diabetes

April 27, 2023 By Sean Whooley

JDRF Humacyte

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Research & Development Tagged With: Humacyte, Juvenile Diabetes Research Foundation (JDRF)

MiniMed 780G a ‘monumental improvement,’ Medtronic Diabetes head says

April 26, 2023 By Sean Whooley

Medtronic MiniMed 780G with Guardian 4 sensor and seven-day infusion set

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: FDA, Medtronic

Medtronic Diabetes unit fully resolves FDA warning letter

April 25, 2023 By Sean Whooley

Medtronic World Diabetes Day

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Technology Tagged With: FDA, Medtronic

Fractyl Health initiates global registry for diabetes reversal treatment

April 25, 2023 By Sean Whooley

This is the logo of Fractyl Health.

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 […]

Filed Under: Business/Financial News, Clinical Trials, Diabetes, Surgical Tagged With: Fractyl Health

FDA clears basal-only insulin pod for type 2 diabetes from Insulet

April 25, 2023 By Sean Whooley

Insulet Omnipod GO basal-only insulin delivery system

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: FDA, Insulet

FDA approves next-gen MiniMed 780G insulin pump from Medtronic

April 24, 2023 By Sean Whooley

Medtronic MiniMed 770G insulin pump system

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: FDA, Medtronic

Fresenius Kabi launches single-needle option for extracorporeal photopheresis

April 24, 2023 By Sean Whooley

Fresenius Kabi logo updated

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Vascular Tagged With: Fresenius Kabi, freseniuskabi

Researchers develop wearable patch for painless drug delivery through the skin

April 21, 2023 By Sean Whooley

MIT Ultrasound Patch for drug delivery

Researchers at MIT hope to address the difficulties of transdermal drug delivery through a new wearable patch. The MIT team sees the skin as an appealing route for drug delivery. It enables the drugs to travel directly to the necessary site, which offers benefits in wound care, pain relief and more. However, the tough outer […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Research & Development, Technology Tagged With: Drug delivery, Massachusetts Institute of Technology, mit, wearables

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