InfuTronix recently announced a voluntary recall of the Nimbus ambulatory infusion pump system from the U.S. market. Following the voluntary removal, the FDA deemed the recall Class I, the most serious kind. It affects 52,328 devices in the U.S. in total. The recall extends to the Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, […]
Drug-Device Combinations
Tandem Mobi automated insulin pump wins FDA nod for expanded pediatric use
Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication. The FDA approved Tandem’s 510(k) application for the use of Mobi in individuals two years of age and older. In an SEC filing dated April 1, the company said the decision came through on March 21. Previously, […]
FDA clears Baxter Novum IQ large-volume infusion pump, Dose IQ safety software
Baxter (NYSE:BAX) announced today that the FDA granted 510(k) clearance for its Novum IQ large-volume infusion pump (LVP) with Dose IQ safety software. Clearance adds the LVP to the Novum IQ platform, which already includes the Baxter syringe infusion pump (SYR). It enables clinicians to utilize a single, integrated system across a variety of patient […]
Tandem Diabetes Care taps miniaturization and automation for its latest systems
Tandem Diabetes Care (Nasdaq:TNDM) EVP and Chief Strategy Officer Elizabeth Gasser didn’t exactly plan for the whirlwind past year or so. In the space of about two months, Tandem announced continuous glucose monitor (CGM) integration with the latest-generation technology from Dexcom and Abbott, launched its Tandem Source diabetes management platform and began the rollout of […]
Ypsomed sells pen needle, blood glucose monitor business to focus on insulin pump
Ypsomed announced today that it agreed to sell its pen needle and blood glucose monitoring (BGM) businesses to Medical Technology and Devices (MTD). With the transfer of these businesses, Ypsomed plans to focus its diabetes care business on insulin pumps. Specifically, it looks to the further development and marketing of the mylife Loop automated insulin […]
ivWatch wins FDA nod for infusion monitoring tech
ivWatch announced today that it received a new FDA 510(k) clearance for its SmartTouch infusion detection and monitoring technology. Clearance covers the detection of iron sucrose extravasation events by the patented SmartTouch sensor and patient monitoring system. It expands the ivWatch system’s ability to better monitor and detect IV extravasations, improving IV safety across more […]
BD ups domestic syringe production in wake of FDA warnings on syringes made in China
BD (NYSE:BDX) announced today that it is increasing its U.S. syringe production after the FDA issued warnings related to syringes manufactured in China. In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality […]
Insulet picks new CFO following McMillan’s move to 3M spinoff
Insulet (Nasdaq:PODD) announced today that it appointed Ana Maria Chadwick as its new EVP, CFO and treasurer. Chadwick’s appointment — which goes into effect on April 22, 2024 — follows an extensive search process conducted by Insulet. That search spanned nearly six months after former CFO Wayde McMillan left for 3M’s Solventum healthcare spinoff in […]
FDA issues warning letter to Medline over plastic syringes from China
The FDA followed up on a 2023 warning letter over unauthorized plastic syringes by issuing a warning letter to Medline. In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated […]
Medtronic is raising the bar on outcomes with MiniMed 780G automated insulin delivery system
Not long ago, automated insulin delivery technology from Medtronic (NYSE:MDT) ranked third in the market in terms of patient satisfaction. That’s according to the Diabetes Patient Voice survey (DQ&A) — a third-party survey that evaluates U.S. diabetes patient satisfaction on a quarterly basis. However, things are now looking up for the world’s largest medtech company […]