Category Archives: Medical Devices

The effects of the New FDA Rule for medical device investigations conducted outside the United States

Posted on August 16, 2019 by

  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 →

Posted in ClinAccel.Net, Clinical Accelerator, FDA, Medical Devices, Regulations | Leave a comment

The ongoing search for the better early-stage clinical trial location: a case study on Australia and Georgia

Posted on July 26, 2019 by

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 →

Posted in Biotech, Central and Eastern Europe, ClinAccel.Net, Clinical Accelerator, FDA, Medical Devices, Patient Enrolment | Leave a comment

Clinical Accelerator announces collaboration with Reprieve Cardiovascular for developing a Cardiovascular system to treat Acute Decompensated Heart Failure

Posted on July 16, 2019 by

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 →

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VisCardia Announces Completion of Enrollment and Three Month Follow-Up Visits for Its VisONE® Heart Failure Pilot Study

Posted on April 30, 2019 by

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 →

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The World’s First VisONE® Implantation: a promising start

Posted on October 30, 2018 by

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 →

Posted in Central and Eastern Europe, ClinAccel.Net, Clinical Accelerator, Medical Devices | Leave a comment