Ypsomed announced that the FDA granted 510(k) clearance for SmartPilot, a digital connectivity add-on for its Ypsomate autoinjectors. The device transforms the YpsoMate into a connected system that automatically captures and transmits injection data. Ypsomed said this marks an important step toward digital health solutions that offer deeper insight into therapy use. The digital add-on […]
Regulatory/Compliance
Medtronic gets FDA nods for MiniMed 780G with Abbott Instinct sensor, expansion to type 2
Medtronic (NYSE:MDT) announced today that the FDA granted two major approvals to broaden access to its MiniMed 780G system. First, the FDA granted clearance for its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC). This enables integration with a sensor made by Abbott, designed specifically through a collaboration between the medtech giants. Second, the […]
ICU Medical issues infusion pump software correction labeled serious by FDA
The FDA issued a notice labeling a recall of ICU Medical (Nasdaq: ICUI) infusion pumps as the most serious type of recall. This recall involves correcting certain devices. It does not require removing them from where they are used or sold. However, the FDA identified that the issue may cause serious injury or death if […]
Abbott wins CE mark for Esprit drug-eluting, dissolving scaffold
Abbott (NYSE: ABT) announced today that it received CE mark for its Esprit BTK everolimus-eluting resorbable scaffold system. Esprit BTK offers treatment for people with peripheral artery disease (PAD) below the knee (BTK). Abbott designed it to keep arteries open and deliver the drug everolimus to support vessel healing. Following the therapy, the stent completely […]
Signos gets FDA green light for over-the-counter CGM for weight management
Signos announced today that it launched its FDA-cleared over-the-counter (OTC) glucose monitoring system for weight management. Palo Alto, California-based Signos integrated the Dexcom Stelo OTC continuous glucose monitor (CGM) with an AI-powered platform for deciphering unique metabolisms. It aims to help people see how food choices, timing, activity, stress and sleep affects their bodies in […]
Tandem picks up FDA clearance for 7-day infusion set
The FDA’s 510(k) database indicates that Tandem Diabetes Care (Nasdaq:TNDM) recently received clearance for an extended-wear infusion set. Tandem’s Capillary Biomedical (CapBio) subsidiary develops the SteadiSet Infusion Set. The wearable infusion set delivers insulin from an insulin pump to the body. Tandem — one of the largest diabetes tech companies in the world — develops the t:slim X2 and […]
Baxter issues correction for some Novum IQ infusion pumps
Baxter (NYSE:BAX) has issued a letter to affected customers recommending a correction for its Novum IQ infusion pump systems. The correction applies to all Novum IQ large volume pumps (LVP) and syringe pumps (SP). Baxter said users should consider alternate pumps if available for care involving high-risk medications and/or critical illness. However, customers can continue […]
Glucotrack to submit long-term CGM implant for FDA IDE this year
Glucotrack (Nasdaq:GCTK) today announced multiple developments in the timeline for its long-term continuous blood glucose monitor (CBGM). The Rutherford, New Jersey-based company plans to file an FDA investigational device exemption (IDE) submission in the fourth quarter of this year. It also remains on track to implant the first patients in a long-term, multi-center feasibility study […]
Sinocare withdraws FDA submission for CGM to focus on next-gen system
Sinocare announced recently that it withdrew its FDA submission for the first-generation iCan i3 continuous glucose monitor (CGM). The company withdrew the FDA 510(k) submission as it looks to instead expedite bringing its next-gen solution to the market. China-based Sinocare designed the iCan i3 CGM for ease of use, with no scanning, no fingersticks and […]
ViCentra to launch next-gen closed-loop insulin pump system in Europe next year
ViCentra today announced its plans to kick off the launch of its next-generation hybrid closed-loop automated insulin delivery system. The company plans to launch the new system, utilizing its Kaleido patch pump, in Germany and the Netherlands in early 2026. Launch plans come on the heels of CE mark approval for Diabeloop’s DBLG2 algorithm, which […]
