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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
ViviGen Cellular Bone Matrix Outperforms MSC-based Allografts and is Equivalent to Gold Standard Autograft According to Recent Peer-Reviewed Publications
"These studies are an exciting advancement of our knowledge of ViviGen," said Mark Moore, PhD, Chief Scientific Affairs Officer at LifeNet Health. "We developed ViviGen based on pre-clinical research that showed a cellular graft focused on viable, lineage-committed bone cells could result in a safe, clinically effective bone void filler.
Sharp Fluidics Clinical Study, Efficacy of a Novel Intraoperative Engineered Sharps Injury Prevention Device: Pilot Usability and Efficacy Trial, Published in JMIR Perioperative...
This study, "Efficacy of a Novel Intraoperative Engineered Sharps Injury Prevention Device: Pilot Usability and Efficacy Trial," Jenny Hillary, M.D., et al. conducted at The Johns Hopkins University School of Medicine, was published in JMIR Perioperative Medicine.
Edwards Lifesciences Treats 1st Patient In U.S. Clinical Trial Evaluating Minimally Invasive Device For Mitral Valve Disease
Edwards Lifesciences notes the HARPOON system uses a less-invasive technique than open-heart surgery in order to treat a type of heart disease called severe degenerative mitral valve regurgitation, which occurs when there is damage to the mitral valve that prevents proper functioning of the valve.
Biospectal Reports 1st Large Scale Clinical Study Published in Scientific Reports Validates the OptiBP™ Generates Blood Pressure Measurements Equivalent to the Traditional Blood Pressure...
The study, conducted in the hypertensive unit of the CHUV hospital at the University Lausanne in Switzerland, showed reference data captured simultaneously with a phone recording blood flow via a smartphone camera on the patient fingertip.
OsteoCool Procedure Shows Significant, Swift Pain Relief and Sustained Improvement for Cancer Patients: According to Journal of Vascular & Interventional Radiology Published Study
The OsteoCool System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body and for ablation of benign bone tumors such as osteoid osteoma.
HeartFlow Reports New JAMA Network Open Publication Demonstrates the Coronary CT- HeartFlow Analysis Pathway Is ‘Dominant’ Compared to Stress Testing in Cost-Effectiveness Analysis
To evaluate clinical effectiveness, the authors looked at lifetime rates of heart attack and death, as well as efficiency of patient selection for invasive diagnostic coronary angiography (ICA) and revascularization, such as a stent procedure or bypass surgery. The authors found that compared to stress testing, coronary CTA with the HeartFlow Analysis improved by 50% the efficiency of selecting patients for invasive testing who then required coronary stenting or bypass procedures.
Aural Analytics Launches Large-Scale Pivotal Study for Its Respiratory and Speech Motor Control Prediction Software Tools: Plans to Submit the Study to the...
Aural Analytics anticipates submitting the results of this multi-site, multi-language, 280 participant, prospective, blinded study to the U.S. Food and Drug Administration (FDA) in late 2021.
Paige Announces New Data on Breast Cancer Detection System To Be Presented at San Antonio Breast Cancer Virtual Symposium December 8-11.
December 7, 2020
Paige, is a global leader in AI-based digital diagnostics. Today the company announced they will present new data evaluating Paige Breast Alpha,...
RenalGuard Therapy Clinical Trial Results Published in the European Journal of Cardio-Thoracic Surgery
December 7, 2020
RenalGuard Therapy better protects at-risk patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) from Acute Kidney Injury (AKI) according to the KIDNEY...