Meditrial Europe awarded ISO 9001:2015 Certification

3 April 2018

Meditrial Europe reaffirms its commitment to continued innovation and leadership in the field of clinical research and digital data management for the medical device industry, being one of the first and very few CROs to achieve ISO 9001:2015 certification. Meditrial’s independent assessment and certification was performed by accredited UK registrar Bureau Veritas Certification Holding SAS.[…]

HighLife closes €12.3 million financing round led by Sofinnova Partners

30 October 2017

HighLife SAS, an early-stage medtech company focused on the development of a unique trans-catheter mitral valve replacement (TMVR) system to treat patients suffering from mitral regurgitation, announced the closing of a €12.3 million investment round led by Sofinnova Partners which becomes the main investor in the company. HighLife had previously secured financing from a corporate[…]

BioVentrix Announces First Patient Enrolled in the U.S. arm of IDE Study of the Revivent TC™ TransCatheter Ventricular Enhancement Treatment

11 October 2017

BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), announced enrollment of the first patient in the U.S. arm of the ALIVE pivotal clinical trial. The trial is designed to demonstrate the safety and effectiveness of the Revivent TC™ TransCatheter Ventricular Enhancement System; a hybrid closed-chest procedure to[…]

CARMAT expands its PIVOTAL study internationally, in line with its clinical strategy and CE marking process

5 October 2017

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that it has received the approval to perform, within the framework of the PIVOTAL study protocol approved by the ANSM (French national agency for[…]

Boston Scientific Announces Agreement to Acquire Apama Medical

2 October 2017

Boston Scientific Corporation (NYSE: BSX) announced a definitive agreement to acquire Apama Medical Inc., a privately-held company that is developing the Apama Radiofrequency (RF) Balloon Catheter System for the treatment of atrial fibrillation (AF). The transaction consists of $175 million in cash up-front and a maximum of $125 million in contingent payments over the period[…]