Abbott today announced data from two real-world studies highlighting the success of its CGM when used with GLP-1 drugs. Data showed that people with type 2 diabetes using GLP-1s with FreeStyle Libre had a greater improvement in HbA1c compared to GLP-1s alone. Abbott presented the findings at the Advanced Technologies & Treatments for Diabetes (ATTD) […]
Clinical Trials
Endotronix has positive pulmonary artery sensor data
Endotronix announced positive six-month results from a pivotal trial evaluating its Cordella pulmonary artery (PA) sensor. Naperville, Illinois-based Endotronix designed Cordella to enable proactive, data-driven heart failure (HF) management. It aims to engage patients, reduce and prevent congestion and improve outcomes. The PROACTIVE-HF trial evaluates Cordella in NYHA Class III HF patients at risk of […]
Gradient begins pulmonary artery denervation trial in the U.S.
Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S. The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary hypertension with associated heart failure. Paris-based Gradient already enrolled the first patient at Duke University Hospital in Durham, North Carolina. Dr. Marat Fudim and […]
GE Healthcare’s AI models can predict patient responses to immunotherapy
GE HealthCare today announced data showing its AI models’ ability to accurately predict patient responses to immunotherapies. The study collected clinical data to accurately forecast the effectiveness and toxicity of cancer immunotherapy. Data demonstrated accuracy between 70% and 80% with the AI models in a pan-cancer cohort. Investigators published outcomes in the Journal of Clinical […]
BD initiates IDE trial of stent for treating peripheral arterial disease
BD announced today that it enrolled the first patient in a trial of its Vascular Covered Stent for treating peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD is evaluating the safety and effectiveness of the stent in its AGILITY FDA investigational device exemption (IDE) trial. The self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol implant is deployed […]
Affluent Medical has positive biomimetic mitral valve data
Affluent Medical today announced positive findings in a clinical evaluation of its Epygon device for replacing mitral valves. The Aix-en-Provence, France-based company designed Epygon to replace mitral valves in those with mitral insufficiency. Epygon is the first biomimetic transcatheter mitral valve to mimic the native mitral valve and restore the natural vortex of blood flow […]
BlueWind reports first patient treated in study of neuromod for urinary incontinence
BlueWind Medical announced today that a doctor treated the first patient in the RESTORE study of its Revi iTNM device. Dr. Osvaldo Padron of Florida Urology Partners in Tampa, Florida, treated the first patient. The prospective, multi-center, open-label, post-market, randomized controlled trial aims to recruit 150 patients across up to 20 U.S. centers. BlueWind designed Revi […]
J&J’s Biosense Webster begins trial for Laminar left atrial appendage elimination device
Johnson & Johnson’s Biosense Webster today announced the start of patient cases with the investigational Laminar LAAX system. In November 2023, Johnson & Johnson MedTech completed a $400 million acquisition of Laminar, With that buy, the company brought in Laminar’s left atrial appendage elimination (LAAX) technology. Unlike other LAA technologies, which exclude or occlude the […]
Pulmonx treats first patient in AeriSeal trial
Pulmonx (Nasdaq:LUNG) announced today that it treated the first patient in a pivotal trial evaluating its AeriSeal system. The CONVERT II trial evaluates AeriSeal in limiting collateral ventilation in severe chronic obstructive pulmonary disease (COPD)/emphysema patients. Pulmonx received a staged FDA investigational device exemption (IDE) to conduct this trial late last year. Collateral ventilation occurs […]
Elon Musk says first Neuralink patient can control mouse with thoughts
Reuters reports that the Elon Musk-backed Neuralink brain-computer interface (BCI) venture has positive early clinical trial results. Musk reportedly said as much in a “Spaces” event on X (the social media website previously known as Twitter and now owned by Musk). The company won a regulatory nod in May for a first-in-human implant, and in September […]
UroMems has positive results for first-ever female implant of smart urinary sphincter system
UroMems announced today that it successfully met the six-month primary endpoint for the first female patient implanted with UroActive. Grenoble, France-based UroMems designed its smart UroActive implant to treat stress urinary incontinence (SUI). The company says it’s the first smart, automated artificial urinary sphincter (AUS) to treat SUI. Powered by a MyoElectroMechanical system (MEMS), UroActive […]