Category Archives: Medical Devices
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
The ongoing search for the better early-stage clinical trial location: a case study on Australia and Georgia
International biotech and medtech companies are constantly searching for optimal locations for their early stage and proof-of-concept clinical trials. An example of a location that has become increasingly popular is Australia. This is in large part due to the great … Continue reading
Clinical Accelerator announces collaboration with Reprieve Cardiovascular for developing a Cardiovascular system to treat Acute Decompensated Heart Failure
Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Reprieve Cardiovascular, LLC for conducting a study aimed at optimally decongesting patients with Acute Decompensated Heart Failure (ADHF). The study will … Continue reading
VisCardia Announces Completion of Enrollment and Three Month Follow-Up Visits for Its VisONE® Heart Failure Pilot Study
Below, we are re-publishing with permission the press-release issued by VisCardia Inc. on April 22, 2019 PORTLAND, Ore.–(BUSINESS WIRE)–VisCardia Inc., a privately held medical device developer, announced today it has completed enrollment and three month follow-up visits of the company’s … Continue reading
The World’s First VisONE® Implantation: a promising start
Below, we are re-publishing with permission the press-release issued by the Heart Institute on the 28th of September 2018 “Thanks to the efforts of the study team from the Heart Institute, we have conducted the first worldwide implantation of the VisONE … Continue reading
