Enable Injections announced today that it received CE mark approval for its EnFuse syringe transfer system for drug delivery. enFuse, an on-body delivery system, provides subcutaneous abdominal bolus administration of drug or biologic products in accordance with the drug product requirements. The mechanical, wearable device can deliver large volumes of small molecule and biologic medications […]
Regulatory/Compliance
FDA clears Tandem Diabetes Care’s next-gen automated insulin delivery algorithm for type 2 diabetes
Tandem Diabetes Care (Nasdaq:TNDM) announced today that the FDA cleared its Control-IQ+ automated insulin delivery algorithm for people with type 2 diabetes. San Diego-based Tandem already has FDA clearance for its AID algorithm for type 1 diabetes. It now joins Insulet in offering AID technology for the type 2 population. Medtronic plans to file with […]
Medtronic seeks to expand MiniMed 780G label to type 2 diabetes, submits new CGM to FDA
Third-quarter results for Medtronic (NYSE:MDT) today included a timeline for a planned label expansion for its automated insulin delivery platform. The medtech giant posted an overall revenue miss for the three months, despite growth in the Diabetes business. (Read more about the company’s third-quarter results at sibling site MassDevice.) Speaking on the company’s earnings call […]
Nasal vaccine devices: Design and regulatory need-to-knows
Nasal vaccine devices have the potential to offer more convenient and more effective protection against a variety of viruses. In 2024, the FDA approved a nasal spray as the first at-home influenza vaccination, allowing adults to vaccinate themselves or someone in their care without a needle jab or a trip to the pharmacy. Intranasal vaccines […]
Medtronic warns on air pressure issue with certain MiniMed insulin pumps in Europe
Medtronic (NYSE:MDT) issued an urgent field safety notice in Europe related to multiple versions of its MiniMed insulin pump systems. The medtech giant’s notice includes models of the MiniMed 640G, 670G, 720G, 740G, 770G and 780G insulin pumps. During quality testing performed by Medtronic, the company said it recently found that changes in air pressure […]
Sinocare prevails in CGM trademark spat with Abbott
Sinocare announced recently that it successfully defended itself in court against trademark infringement claims brought by Abbott (NYSE:ABT). The China-based continuous glucose monitor (CGM) maker defended itself in the High Court of Justice (Chancery Division) of England and Wales against claims regarding trademark infringement and passing off. Abbott claimed that Sinocare’s iCan i3 CGM system […]
Dexcom warns of missed G6 receiver alerts in Europe
Dexcom (Nasdaq:DXCM) recently issued an urgent field safety notice in Europe warning of a potential issue with certain G6 receivers. G6 continuous glucose monitor (CGM) receivers deliver glucose readings and alerts. However, certain devices may experience an issue in which alarms/alerts fail to function as designed. In rare instances, the alarm/alert may be missed or […]
Senseonics submits year-long CGM for CE mark
Senseonics (NYSE:SENS) announced today that it filed for CE mark for its Eversense 365 continuous glucose monitor (CGM) system. Eversense 365, the world’s first 365-day CGM system, is the only CGM offering a year-long wear time. Market-leading, non-implanted CGMs like Abbott’s and Dexcom’s are worn for around two weeks. For Eversense 365 users, this means […]
FDA warns of potential missed alerts with smartphone-connected diabetes devices
The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical safety alerts. Devices like continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems can use smartphones to deliver alerts. Users can configure alert settings through applications on their phone. The FDA received medical […]
Abbott, Dexcom settle global CGM patent litigation
Abbott (NYSE:ABT) announced today that it reached an agreement with Dexcom (Nasdaq:DXCM) to settle all outstanding patent disputes between companies. The patent litigation relates to the companies’ continuous glucose monitor (CGM) technologies. Abbott and Dexcom are two leaders in the CGM space. They offer market-leading platforms, with Abbott’s FreeStyle Libre 3 and Dexcom’s G7 representing […]
