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 […]
Drug-Device Combinations
Insulet picks new CFO following McMillan’s move to 3M spinoff
Insulet 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 October. […]
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 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 in […]
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
Every year, the diabetes community comes together for the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). In the 17th installment at the start of this month, some of the biggest names shared new studies and technologies set to advance the diabetes space. Dexcom, Abbott, Medtronic and more contributed on their end, while […]
Boston Scientific has positive Agent DCB study results
Boston Scientific 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 an alternative to […]
Medtronic highlights global performance of MiniMed 780G automated insulin delivery system
Medtronic 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 range […]
Innovation Zed, Enhance-D collab on insulin dosing management
Innovation Zed announced this week that it entered into a strategic partnership with Enhance-D to optimize diabetes therapy. Switzerland-based Enhance-D develops a digital health platform for enhancing diabetes and exercise management. It designed its platform to empower people with diabetes through cutting-edge technologies and personalized solutions. Ireland-based Innovation Zed develops insulin dosing technology, including the […]
Roche unveils new CGM tech with predictive AI, outlines diabetes strategy
Roche today gave a presentation debuting its first continuous glucose monitor (CGM) offering that utilizes predictive AI. The company unveiled its Accu-Chek SmartGuide in an event at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy. It remains an investigational device not yet authorized for sale. Julien Boisdron, Roche Diabetes Care’s chief medical […]
Smiths Medical recall affects nearly 86,000 syringe pumps with software issues
Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions. The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump […]