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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Fogarty Innovation Graduate Raydiant Oximetry Raises $5 Million in Oversubscribed Series A2 Financing Round to Support Clinical Study
Innovative technology designed to keep mothers and babies safe during childbirth.
1st U.S. Patient Enrolled in Cardionomic’s CPNS System Pilot Study
The study is evaluating the safety and performance of the CPNS System in patients suffering from acute decompensated heart failure (ADHF), defined as new or worsening symptoms of heart failure. The first U.S. patient was enrolled and implanted at The Ohio State University Wexner Medical Center in Columbus, OH by Principal Investigator, Dr. Sitaramesh Emani, assisted by Dr. Rami Kahwash.
Innovative Embolic Device Shows Promise for Interventional Oncology Drug Delivery
The GPX Embolic Device is under development and does not have marketing clearance or approval in any market at this time. For investigational use (in New Zealand) only. GPX-DOX Embolic Device is under development and does not have marketing clearance or approval in any market at this time.
VenoStent Embarks on Clinical Trial to Improve Success Rate of Vascular Surgery Outcomes
Tim Boire, CEO said, “After years of development, we are confident that our bioabsorbable wrap technology can have a positive impact on the lives of patients that require hemodialysis to sustain life.
CathVision Announces First Patient Enrollments in PVISION Multicenter Clinical Study
The PVISION study is the perfect opportunity to demonstrate the importance of enhanced EP recording technology and AI algorithms in shaping the future of diagnosing, characterizing and treating complex arrhythmias.
STALIF C-Ti® Study Published Journal of Surgery & Anesthesia Research
The clinical study utilizing the STALIF C-Ti integrated cage-screw implants was performed in 145 patients and 12-month outcome scores demonstrated significant improvement in all available patient reported outcome scores collected (p<0.05 for all), including NDI, VAS neck, VAS left arm, and VAS right arm.
Data Presented at ASTRO 2021 Validate Prognostic Value of Decipher Prostate Genomic Test in Newly Diagnosed, Clinically High-Risk Prostate Cancer
“This analysis provides the first clinical evidence that the Decipher Prostate classifier can help physicians and patients make critical, personalized treatment decisions in the post-biopsy, clinically high-risk prostate cancer setting,” said Elai Davicioni, Ph.D., Veracyte’s senior vice president of scientific and clinical operations, Urologic Cancers.
Accuray CyberKnife® Robotic Radiotherapy Platform Could Significantly Improve Survival in Early-Stage Breast Cancer Patients
Study investigators performed complex modeling that also indicates the survival rate could be better with CyberKnife APBI than other radiation delivery approaches including volumetric-modulated arc therapy, three-dimensional conformal radiation therapy ABPI and high dose rate brachytherapy.
Ocular Therapeutix™ Announces Topline Results for Phase 2 Clinical Trial of OTX-CSI for the Treatment of Dry Eye Disease Did Not Meet Primary Endpoint
The Phase 2, U.S.-based, randomized, double-masked, multi-center, vehicle-controlled clinical trial of OTX-CSI was designed to evaluate safety, tolerability, durability, and efficacy of two different formulations of OTX-CSI by measuring signs and symptoms of DED in 140 subjects treated in both eyes over approximately 16 weeks (a 12-week study period, with an additional 4-week safety follow-up).