HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Know Labs Demonstrates Improved Accuracy of Machine Learning Model for Non-Invasive Glucose Monitor
The study demonstrates that continued algorithm refinement and more high-quality data improved the accuracy of Know Labs’ proprietary Bio-RFID sensor technology, resulting in an overall Mean Absolute Relative Difference (MARD) of 11.3%.
i-SEP Reports Results of Its 1st Clinical Study Conducted on 50 Cardiac Surgery Patients
"This clinical study is a major milestone for i-SEP, a testament to many years of investment and hard work. This publication in Anesthesiology is a great reward for our team and our partners, who have worked relentlessly to bring this technology to life. It will open many doors in France and globally." - Sylvain Picot, Chairman of i-SEP
New Clinical Study Shows Unprecedented Results of ART MEDICAL’s smART+ Platform, Including Significant Reduction in Length of Stay, Ventilation Days in ICU and Improved...
The study demonstrated the smART+ Platform can maximize feeding efficiency, reaching nearly 90% of the targeted nutrition goal and improve patient outcomes by reducing both ICU length of stay and length of ventilation by 3.3 days. This breakthrough is an important step toward the commercialization of ART MEDICAL's revolutionary technology.
Dimerix Kidney Trial Outcome Q1 2024
With randomisation of the first cohort of patients complete, the final data collection is scheduled on 26 February 2024, with the Part 1 interim outcome expected to be announced on, or around, 15th March 2024.1 The trial continues to recruit patients for Part 2 of the trial.
Biosense Webster Completes Enrollment in Pivotal Trial Evaluating PFA and RF Dual Energy Catheter for Patients with Atrial Fibrillation in Europe
Biosense Webster reported SmartfIRE is a pivotal, prospective, multi-center, single-arm study evaluating Biosense Webster’s dual energy pulsed field (PF) and radiofrequency (RF) ablation system. Since the study’s commencement in February 2023, the trial has enrolled 149 patients with paroxysmal AFib across nine centers in Europe. Patients will be assessed for 12 months for safety and efficacy.
Elixir Medical Completes Enrollment in INFINITY-SWEDEHEART Clinical Trial of DynamX™ Coronary Bioadaptor System
The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. The trial is part of the ongoing Swedeheart registry program in Sweden, a national collaborative research program launched in 2009 to support the evidence-based development of therapies for coronary heart disease.
Copper Could Help Create Clearer MRI Images and Improved Diagnosis – Study
Researchers discovered a novel copper protein binding site, which does not occur in nature, that has real potential for use in MRI contrast agents used to improve the visibility of internal body structures in scans.
Graphene Sensors May Help to Detect Sepsis Earlier in Critically Ill Patients
A new study from the University of Bath has shown that graphene-based biosensors, designed by Integrated Graphene, have the potential to play a major role in detecting increased levels of lactate, an important biomarker for the treatment of critically ill patients.
Gore announces First U.S. Enrollment for the GORE® VIAFORT Vascular Stent iliofemoral Study
The first U.S. patient was enrolled by David J. Dexter II, M.D. at Sentara Vascular Specialists, Norfolk, Virginia. "With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the VIAFORT Device is compelling to use in a clinical trial," he said.