LONDON – Mologic Ltd. has started recruitment in a 263-patient trial to validate its urine-based home test for anticipating exacerbations of chronic pulmonary obstructive disease (COPD). The lateral flow immunoassay self-test detects five biomarkers of the lung disease in urine that are indicative of inflammation and infection.
Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The real-world trial assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adults.
Stanford University School of Medicine and Apple Inc.have published results from the largest digital-only study. The trial has been conducted in more than 400,000 people in the U.S. over more than eight months. It was set up to screen participants via their Apple Watch for heart irregularities and then to further monitor any of those with identified issues with a wearable ECG patch.
Fractyl Laboratories Inc. is pioneering a procedure known as duodenal mucosal resurfacing (DMR) to reverse chronic metabolic disorders. This month it has reported positive results from a couple of clinical trials that are shaping its planning for a pivotal trial that is slated to start next year in type 2 diabetes patients.
Edwards Lifesciences and Medtronic have struggled for supremacy for transcatheter aortic valve devices for several years, but two recent studies suggest the Edwards line of devices provide better outcomes. However, another study gave new life to the notion that TAVR devices are underutilized, signaling that there is plenty of market for both companies.
Dublin-based Medtronic plc is highlighting results from the MARVEL 2 study showing that an investigational set of algorithms in the Micra Transcatheter Pacing System (TPS) helps those with normal sinus node function and atrioventricular (AV) block.
Most weight loss interventions target obese or super-obese patients who have adjacent comorbidities, such as type 2 diabetes or sleep apnea. But Boston-based Gelesis aims to change that with its hydrogel pill Plenity.
Penumbra Inc. reported final results from its IDE trial of the Indigo Aspiration system at the Vascular Interventional Advances (VIVA) annual meeting in Las Vegas. The Alameda, Calif.-based company said that the EXTRACT-PE trial met its primary endpoints in patients with acute pulmonary embolism (PE).
LONDON – Nyxoah SA reported positive clinical results for Genio, its lead-free, battery-less implantable neurostimulation device, showing it resulted in a significant reduction of the severity of obstructive sleep apnea (OSA), the world's most common sleeping disorder.
Navidea Biopharmaceuticals Inc. disclosed positive results from the first interim analysis of its ongoing NAV3-31 phase IIb study. Analysis shows the data support Navidea's hypothesis that Tc 99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA).
RSS
