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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
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...
Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing
Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.
Balt STEM Trial: First Patients Enrolled
The company recently announced that the first patients have been enrolled in the clinical trial; The SquidTM Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic subdural hematoma [NCT04410146].
W. L. Gore & Associates Announces Six-Month Results With Biosynthetic Tissue Valve
W. L. Gore & Associates notes the six-month data for 16 patients enrolled across three sites in the United States were presented in a moderated poster session during the American Heart Association Virtual Scientific Sessions from November 13-17, 2020. The poster, P148, is titled, Early Results of a Novel ePTFE-based Pulmonary Valved Conduit in a Pediatric Patient Population.
SODAQ and Nordic Complete a Successful Pilot with a Covid-19 Corona Vaccine Temperature Tracker
November 26, 2020
SODAQ completed 50 successful runs tracking the location and temperature threshold of vaccine shipment containers from va-Q-tec by using the Nordic Semiconductor NRF91 communication...
ISABELLA Trial with SELUTION SLR 018 DEB Patient Trial Update: Successful Recruitment of 40 Hemodialysis Patients
ISABELLA Trial (Intervention with SELUTION SLR Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas) s a prospective single-center, multi-investigator, non-blinded, single arm trial investigating the safety and feasibility of SELUTION SLR 018 DEB for the treatment of failing AV fistulas in 40 hemodialysis patients.