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 […]
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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 […]
FDA clears automated insulin delivery system from Sequel Med Tech
Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system. The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market […]
The biggest diabetes tech news out of ATTD 2024
Catch up on the latest in diabetes tech from Dexcom, Abbott, Roche Diabetes Care, Insulet, Medtronic and Know Labs. Every year, the diabetes community comes together for the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). In this year’s 17th installment, some of the biggest names shared new studies and technologies set to […]
Ascensia, Senseonics announce new CGM cost savings
Ascensia Diabetes Care and Senseonics today announced an extension to their Eversense Payment Assistance and Simple Savings (PASS) program. The program aims to help people in the U.S. access the Eversense E3 continuous glucose monitor (CGM) more affordably. It offers major savings for eligible individuals looking to experience the benefits of the long-term, implantable CGM. […]
Boston Scientific has positive Agent DCB study results
Boston Scientific [WtwhTicker symbol=”BSX”](NYSE: BSX)[/WtwhTicker] reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as […]
Medtronic highlights global performance of MiniMed 780G automated insulin delivery system
Medtronic (NYSE:MDT) shared new clinical and real-world evidence backing the use of its MiniMed 780G system around the world. Data shared at ATTD 2024 in Florence, Italy, included the largest set of data from early users in the U.S. Results built upon three-year data from more than 100,000 real-world users who outperformed international time in […]