Category Archives: Medical Devices
Clinical Accelerator collaborates with Metavention on a study of a novel medical device for hypertension
Clinical Accelerator and Metavention have recently entered into a collaboration allowing Clinical Accelerator to join the program of feasibility studies already under way in the United States, New Zealand and Australia. Our organization will participate in the renal denervation trial … Continue reading
Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology
Innovative technology offers an implant-free approach for individuals with chronic heart failure January 25, 2021 10:16 AM Eastern Standard Time AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) … Continue reading
Posted in Cardiology, Medical Devices
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Axon Therapies Announces Positive Results From First-In-Human Clinical Study in Late-Breaking Clinical Trial Session At 2020 Virtual HFSA Conference
Below, we are re-publishing with permission the press-release issued by Axon Therapies, Inc. on October 09, 2020 Satera™ Ablation System demonstrates success as a frontline treatment of heart failure NEW YORK, Oct. 9, 2020 /PRNewswire/ — Axon Therapies, a Coridea portfolio company focused … Continue reading
Sequana Medical announces strong interim results from RED DESERT alfapump® DSR study and provides business update
Below, we are re-publishing with permission the press-release issued by Sequana Medical on October 22, 2020 RED DESERT: Results from first five patients indicate repeated dose alfapump DSR therapy to be safe and effective Interim data support DSR hypothesis: kidneys … Continue reading
Posted in Central and Eastern Europe, Clinical Accelerator, Medical Devices
Tagged clinical trials
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Clinical Accelerator to collaborate with Second Heart Assist on a Phase I study in Heart Failure
Clinical Accelerator and Second Heart Assist have recently entered into an exciting new collaboration, focused on developing a novel device for heart failure patients. An early feasibility trial will be conducted on Second Heart’s aortic stent based circulatory assist pump. … Continue reading
Second Heart Assist Announces Successful Completion of Long-Duration Pre-Clinical Studies
Below, we are re-publishing with permission the press-release issued by Second Heart Assist Inc. on June 22, 2020 Salt Lake City, Utah, June 22nd, 2020 /PRDistribution/ — Second Heart Assist Inc., inventors of the first, true, aortic stent-based circulatory assist pump … Continue reading
Clinical Accelerator continues its collaboration with Sequana Medical, a medical device company developing the alfapump DSR System for the treatment of Diuretic Resistant Heart Failure
Clinical Accelerator, a full-service contract research organization with a strong focus on medical device investigations, is pleased to report that despite the global disruption caused by Covid-19, work has been continued in the Republic of Georgia on RED DESERT – … Continue reading
Clinical Accelerator and BetaGlue Technologies to conduct First in Human Medical Device Investigations in Breast Cancer and Liver Cancer
Clinical Accelerator is pleased to announce an exciting new collaboration with BetaGlue Technologies SpA. Two studies will be conducted, one on radio-ablation of surgical margins following resection of breast ductal carcinoma in situ (DCIS), in 20 patients and one of … Continue reading
Clinical Accelerator collaborates with Axon Therapies on a First-In-Human Feasibility Study for Heart Failure
Clinical Accelerator, a full-service contract research organization is pleased to report on its continuous collaboration with Axon Therapies, an early-stage, US-based medical technology company. Axon Therapies has developed a novel device – the Axon System – with a neuromodulation approach … Continue reading
The effects of the New FDA Rule for medical device investigations conducted outside the United States
On February 21, 2019 the new US FDA rule on medical device clinical investigations conducted outside the United States (OUS) became effective. In this post, we would like to discuss the difference between the old and the new regulation and … Continue reading
