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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
ReCor Medical Announces Completion of Enrollment in RADIANCE-II Pivotal Trial
ReCor Medical notes the data from RADIANCE-II will build on evidence from RADIANCE-HTN SOLO and TRIO studies to support pre-market application to the FDA
HeartPoint Global Implant System Proves Safety and Efficacy
HeartPoint Global notes this new milestone follows the company's successful exploration of the HeartPoint Global Implant System in the arterial branches.
SpineX Announces Successful 1st in Human Study Results of SCONE therapy to treat Urge Urinary Incontinence
SpineX notes SCONE™, a non-invasive transcutaneous spinal cord neuromodulator is the first of its kind device that is being developed to treat bladder dysfunction.
Hinge Health Reports: New Study Demonstrates that Hinge Health Delivers Sustained 1-year Improvement in Pain, Anxiety, Depression, and Function
Hinge Health said a joint study with researchers from UCSF and the University of Rhode Island is the first to demonstrate long-term outcomes of a digital musculoskeletal solution.
Type 1 Diabetes and AI: Harnessing the Power of AI to Advance Knowledge of Type 1 Diabetes
In the study, the team analyzed publicly available, real-world data from about 16,000 participants enrolled in the T1D Exchange Clinic Registry.
LFM Healthcare Solutions Reports Comprehensive Endoscope Study Reveals More Patients Are Potentially Being Exposed to Pathogens
LFM Healthcare Solutions notes he study also notes that these “adverse-event reports” filed by hospitals, endoscope manufacturers, patients and other stakeholders rose markedly in all categories of studied endoscopes from 2014 to 2021 and continued to “increase significantly” from 2019 to 2020 for urological endoscopes and colonoscopes “when the number of elective or non-urgent endoscopic procedures performed during the pandemic decrease in the U.S. and globally
Cardiovascular Systems First In-Human Experience With Company’s Propel™ Percutaneous Ventricular Assist Device
Cardiovascular Systems advises the first series of patients was treated by Dr. David E. Kandzari, MD, FACC, FSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Atlanta, Ga., performed in Tbilisi, Georgia.
First U.S. Trial using GI Genius™ Intelligent Endoscopy Module Report from Medtronic
Medtronic notes the study, published on March 15 in Gastroenterology, the official medical journal of the American Gastroenterological Association, found that the use of GI Genius in conjunction with colonoscopy significantly decreases the miss rate (2x) of colorectal polyps and adenomas compared to standard colonoscopy.
Instylla First-In-Human Clinical Trial Published Results
Instylla notes prospective multicenter study evaluated the safety and efficacy of a PEG-based liquid embolic in treating hypervascular tumors.