Senseonics (NYSE:SENS) announced today that it completed its ENHANCE pivotal clinical study adult cohort for its 365-day Eversense CGM. Germantown, Maryland-based Senseonics’ ENHANCE study recorded the completed 365-day visit for the final study patient. The study evaluates the year-long implantable continuous glucose monitor in adults. It also has a pediatric cohort (ages 14 to 18), […]
Clinical Trials
Vaxxas wins $3.7M award to support needle-free typhoid vaccine tech
Vaxxas announced that it received a $3.67 million award to conduct studies of a typhoid vaccine delivered by its needle-free device. The company develops a vaccine patch based on its proprietary HD-MAP delivery technology. Vaxxas designed its HD-MAP technology to use an ultra-high-density array of micro projections, invisible to the human eye. Applied to the […]
2-year data backs DarioHealth digital diabetes platform
DarioHealth (Nasdaq:DRIO) today announced new research demonstrating sustainably improved outcomes with its digital diabetes platform. New York-based DarioHealth designed its digital health solutions to combine a clinically intelligent platform with consumer insights. It helps to drive sustainable behavior change to improve the management of chronic conditions, including diabetes. The research, presented at the ADCES23 Annual […]
Advanced NanoTherapies picks up $4M investment for drug-coated balloon development
Advanced NanoTherapies announced today that it collected a $4 million Series A extension from an undisclosed strategic investor. Los Gatos, California-based Advanced NanoTherapies received the investment from a medical device company. It also announced the successful treatment of the first cohort of study participants in its drug-coated balloon trial. The first-in-human trial evaluates initial short-term […]
Orchestra BioMed wins FDA IDE for drug-coated balloon study
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra BioMed designed Virtue SAB to enable the protected […]
Know Labs has more positive data for its non-invasive glucose monitor
Know Labs (NYSE:KNW) today announced results from a new study that further demonstrate the accuracy of its Bio-RFID sensor technology. Last month, the company unveiled the prototype for its proprietary non-invasive sensor technology. Its proprietary Bio-RFID technology uses spectroscopy to direct electromagnetic energy through a substance or material. Through this, it can capture a unique molecular signature. The […]
Research highlights cost savings from DarioHealth digital diabetes therapeutic
DarioHealth (Nasdaq:DRIO) announced today that a new analysis demonstrated a significant cost reudction for users of its digital therapeutic platform. Sanofi U.S. conducted the analysis, which showed lower costs of care for DarioHealth users compared to non-users with type 2 diabetes. The study used matched claims to show an estimated $5,077 in medical cost savings […]
Feasibility study backs Glucotrack implantable CGM
Glucotrack (Nasdaq:GCK) announced today that it completed a feasibility study for its implantable continuous glucose monitor (CGM). Rutherford, New Jersey-based Glucotrack designed its CGM for patients with type 1 and type 2 insulin-dependent diabetes. The company said late last year that it planned to expand its product pipeline with an R&D program. The program centers around developing […]
Better Therapeutics wins FDA nod for type 2 diabetes digital therapeutic
Better Therapeutics (Nasdaq:BTTX) announced that the FDA authorized its AspyreRx prescription digital therapeutic for diabetes. AspyreRx, formerly BT-001, provides cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The prescription-only digital therapeutic (PDT) underwent review through the FDA de novo pathway. The company submitted an FDA de novo request in September 2022 for […]
Study supports use of CamDiab artificial pancreas in pregnant women with type 1 diabetes
The CamDiab CamAPS FX automated insulin delivery (AID) system produced better outcomes for pregnant women with type 1 diabetes in a clinical study. Medscape reported that data came from the largest randomized controlled trial pitting an AID system against standard insulin delivery in pregnant women with type 1 diabetes. The automated CamAPS FX came out […]
