Tandem Diabetes Care (Nasdaq:TNDM) today announced study findings highlighting the benefits of its automated insulin delivery system. Findings from the “Adults with Type 2 Diabetes Benefit from Automated Insulin Delivery Irrespective of C-peptide Level” study were published in the American Diabetes Association’s Diabetes Care. The study, a sub-analysis from the 2IQP trial, found that Control-IQ+ automated […]
Clinical Trials
Modular Medical can start insulin patch pump feasibility study
Modular Medical (Nasdaq:MODD) announced that it received Institutional Review Board (IRB) approval to study its next-generation insulin pump. San Diego-based Modular Medical can now conduct an in-house feasibility study for its next-generation Pivot insulin delivery system. The company plans for the study of the new pump to use sterile saline. Modular Medical unveiled Pivot, its […]
Medtronic reports positive 3-year automated insulin delivery data
Medtronic (NYSE:MDT) today shared three-year real-world evidence highlighting improvements with its MiniMed 780G automated insulin delivery system. MiniMed 780G, the company’s latest-generation AID system, offers meal detection technology and provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs. Data demonstrated rapid, sustained […]
Dexcom to unveil new basal insulin titration module under FDA review, reports positive CGM data
Dexcom (Nasdaq:DXCM) today announced plans to unveil its Smart Basal integrated titration module for insulin delivery. The company plans to unveil Smart Basal and present new continuous glucose monitor (CGM) data at the 61st annual European Association for the Study of Diabetes (EASD) Conference in Vienna, Austria, this week. Dexcom’s CTO Girish Naganathan will speak […]
Teleflex enrolls first patient in dual-drug-eluting device study of coronary interventions for diabetes
Teleflex (NYSE:TFX) announced today that it enrolled the first patient in its DUBSTENT DIABETES trial. The randomized, investigator-initiated trial evaluates a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus. DUBSTENT DIABETES investigates the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies […]
Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
Airiver Medical announced today that it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. This FDA IDE – the company’s first — allows it to begin a pivotal clinical trial of the technology. Central airway stenosis (airway narrowing) […]
Boston Scientific launches head-to-head drug-coated balloon trial
Boston Scientific (NYSE:BSX) announced today that it initiated a new trial to assess its Agent DCB compared to the standard of care. The AGENT DCB STANCE trial pits the drug-coated balloon (DCB) head-to-head against percutaneous coronary intervention (PCI) treatment with drug-eluting stents (DES) and/or balloon angioplasty – in patients with de novo (previously untreated) coronary […]
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 […]
Trinity Biotech reports positive outcomes with next-gen CGM sensor
Trinity Biotech (Nasdaq:TRIB) today announced positive clinical trial results for its next-generation continuous glucose monitor (CGM). Dublin, Ireland-based Trinity Biotech unveiled its CGM+ next-gen wearable biosensor last month. With CGM+, the company aims to take on the growing AI wearables market. The company said it has the system in the later stages of device development. […]
BD announces first pharma-sponsored clinical trial for wearable injector
BD (NYSE:BDX) today announced the first pharma-sponsored combination product clinical trial using its wearable injector technology. The study uses the BD Libertas wearable injector for the subcutaneous delivery of complex biologics. The company said it represents a significant advancement in accelerating innovation in drug-device combination products. It could provide greater flexibility for patients, including potential […]
