HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
First Patient Enrolled in Pivotal Atherectomy Clinical Study
Ra Medical received investigational device exemption (IDE) approval for the atherectomy clinical study from the FDA in January 2020.
FDA Approves to Continue the PROMISE Sensor Clinical Study in an Extended Cohort to 365 Days to Gather Feasibility Data
PROMISE Sensor Clinical Study is to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over a 180-day period for the pre-market application submission to the U.S.
Peregrine Post-Market Study Published in the Journal of the American College of Cardiology: Cardiovascular Interventions
Peregrine Post-Market Study is a European multicenter open-label trial that evaluated additional safety and performance of the Peregrine System Infusion Catheter using a neurolytic agent (dehydrated alcohol) delivered into the space outside of the renal (kidney) arteries in 45 patients with systemic hypertension.
Large Clinical Study to Support Underway Reports Diabeloop
Note: In December 2019, the company completed a record-breaking Series B funding round of 31 million euros intended to support its launch strategy in major international markets (particularly in Europe and the United States).
Published Real-World Experience Demonstrates VasQ External Support Improves Outcomes When Adopted as the Standard of Care
The paper demonstrated that using VasQ as the standard of care for radiocephalic fistulas resulted in a significant improvement in his center’s primary fistula failure and longer-term secondary patency rates with less repeat interventions when compared to historical controls.
Publication of COMPASS Study Validating First Scoring Guidelines for WatchPAT™ Device in Diagnosing Sleep Apnea
The COMPASS Study appears online in the Journal of Clinical Sleep Medicine.
Breakthrough Study Published Measuring the Effect of EOTTS to Reduce Medial Knee Compartment Forces
GraMedica reports, the first of its kind, the study measured the in vivo forces acting within the medial knee compartment, before and after EOTTS.
BD Completes Clinical Trial for BD Libertas Wearable Injector Completed
The award-winning Libertas Wearable Injector is a subcutaneous drug delivery system, currently in development, that is designed to require no patient assembly and deliver biologics with viscosities up to 50 cP in 2-5 mL and 5-10 mL configurations.
BrainsWay Announces Data from Feasibility Study of Deep Transcranial Magnetic Stimulation System
BrainsWay advises the results showed a statistically significant improvement in patient-reported assessments of inattention, together with a significant increase in activity that was observed within the dorsolateral prefrontal cortex, a brain area previously shown to express reduced activity in adults with ADHD.