Medtronic (NYSE:MDT) announced today that it submitted 510(k) applications to the FDA seeking clearance for an interoperable insulin pump. Clearance would enable system integration with a continuous glucose monitor (CGM) sensor based on Abbott’s most advanced platform. This marks the latest development in a landmark collaboration between the two medtech giants. Last summer, the companies […]
Regulatory/Compliance
Medtronic wins FDA nod for new Simplera Sync CGM with MiniMed 780G
Medtronic (NYSE:MDT) announced that the FDA approved its Simplera Sync continuous glucose monitor for use with the MiniMed 780G. Approval provides more options for users of the automated insulin delivery (AID) system, which can also work with the Guardian 4 sensor. Simplera Sync, a disposable, all-in-one sensor requires no fingersticks or overtape. It works with SmartGuard […]
Tidepool achieves new certification for open-source quality management system
Tidepool announced today that it secured a new certification for its open-source quality management system, known as qmsOS. Palo Alto, California-based Tidepool, a non-profit diabetes data management group, develops open-source technology for the diabetes community. That includes the FDA-cleared Tidepool Loop, a “do-it-yourself” (DIY) automated insulin delivery (AID) system. Recent collaborations include integrations with Abbott and Sequel […]
Dexcom wins FDA nod for 15-day CGM
Dexcom (Nadsaq:DXCM) announced today that the FDA cleared its G7 15-day continuous glucose monitoring (CGM) system. The clearance covers people over the age of 18 years old in the U.S. It makes the G7, Dexcom’s latest-generation CGM, the longest-lasting wearable CGM, according to the company. San Diego–based Dexcom submitted its 15-day G7 CGM to the […]
SiBionics unveils ‘world’s thinnest’ CGM, earns CE mark
SiBionics announced today that it unveiled its GS3 continuous glucose monitor (CGM), which now has CE mark approval. The company unveiled the device — which it touts as the world’s thinnest CGM — at last week’s 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Amsterdam. GS3 features an ultra-compact design and […]
Enable Injections wins CE mark for enFuse drug delivery device
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 […]
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 […]
