CE marked system articles & resources on Made-in-China.com

Medtronic's Affinity Fusion Oxygenation System Get Approval From FDA

Apr 3, 2013

US-based medical technology company Medtronic has secured US marketing rights for its Affinity Fusion oxygenation system following the regulatory approval from the US Food and Drug Administration (FDA). The CE-marked system, which serves ...

Tags: FDA, Fusion Oxygenation System

Halt Medical Has Obtained $15m Finance From American Capital

Jan 4, 2013

Halt Medical has obtained $15m finance from American Capital to support the commercialization of its Acessa system, designed for treating uterine fibroids. Using a slender Handpiece, the CE-marked system delivers radiofrequency energy to ...

Tags: Halt Medical, American Capital, commercialization, Acessa system

Unconditional FDA Approval for C-Pulse Heart Assist Device Is Won by Sunshine

Dec 18, 2012

Sunshine Heart is planning to initiate a US pivotal trial on its C-Pulse Heart Assist device in the fourth quarter of 2012, as it received an unconditional approval from the US Food Drug Administration (FDA). The CE marked system, ...

Tags: FDA, clinical trial, medical system

BioCardia Announces Positive Results From a Phase I/II Trial of Its Helical Infusion Syste

Dec 17, 2012

BioCardia has announced positive results from a Phase I/II trial of its Helical Infusion system, designed to deliver donor's (allogeneic) or treated patient's (autologous) adult mesenchymal stem cells (MSCs) via transendocardial stem cell ...

Tags: Helical Infusion system, stem cell injection, device, Infusion System

FDA Clears Boston Scientific's S-ICD to Treat Patients at Risk for SCA

Dec 17, 2012

The US Food and Drug Administration (FDA) has cleared Boston Scientific's subcutaneous implantable cardioverter defibrillator (S-ICD) to treat patients at risk for sudden cardiac arrest (SCA). The CE-marked system, which the company ...

Tags: FDA, CE-marked system, S-ICD system

Volcano Has Entered Into an Agreement to Buy Us-Based Crux Biomedical for $36m in Cash

Dec 6, 2012

Volcano, a manufacturer of precision guided therapy tools, has entered into an agreement to buy US-based Crux Biomedical for $36m in cash. Crux Biomedical's product includes the Crux VCF system, an inferior vena cava (IVC) filter, which ...

Tags: precision guided therapy tools, buy.Crux Biomedical, Crux VCF system