Standards and Certification - Page 1

EC clears Boston Innova bare-metal stent system
Tuesday, May 15, 2012 The European Commission (EC) has granted CE-mark approval for Boston Scientific's Innova self-expanding bare-metal stent system, which is designed to treat peripheral vascular lesions in...

FDA clears St. Jude Ellipse cardioverter defibrillator
Friday, May 11, 2012 St. Jude Medical's Ellipse implantable cardioverter defibrillator (ICD) has gained US Food and Drug Administration (FDA) approval for treating lethal, abnormally fast heart rhythms that often...

European Commission approves Loma Vista True Dilatation balloon catheter
Friday, May 11, 2012 Loma Vista Medical has received CE mark clearance for its True Dilatation balloon valvuloplasty catheter, indicated for preventing balloon ruptures in balloon aortic valvuloplasty (BAV)...

Boston Scientific cardiac pacemakers win FDA approval
Tuesday, May 08, 2012 The US Food and Drug Administration (FDA) has granted Boston Scientific approval to market its Ingenio and Advantio pacemakers, along with Invive cardiac resynchronisation therapy pacemakers...

FDA clears Nephros' hemodiafiltration system
Wednesday, May 02, 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Nephros' hemodiafiltration (HDF) system, designed for the treatment of chronic kidney disease...

FDA clears Galt VTI valved tearaway introducer
Friday, April 27, 2012 Galt Medical, a wholly-owned subsidiary of Theragenics, has received US Food and Drug Administration 510(k) clearance to market its Galt VTI valved tearaway...

Boston Emerge dilatation catheter gets European approval
Thursday, April 26, 2012 Boston Scientific has gained European marketing approval for its Emerge PTCA dilatation catheter designed for treating coronary artery...

US clears Carestream mobile x-ray system
Friday, April 20, 2012 The US Food and Drug Administration (FDA) cleared Carestream's DRX-Revolution mobile x-ray system which improves image quality, manoeuvrability and...

St. Jude Medical Ellipse ICD now available in Europe
Tuesday, April 17, 2012 St. Jude Medical has gained European marketing approval for its Ellipse implantable cardioverter defibrillator (ICD), designed to treat potentially lethal, abnormally fast heart rhythms which...

OptiMedica wins CE mark for Catalys laser system
Friday, April 13, 2012 The European Commission (EC) has granted CE mark approval for OptiMedica's Catalys precision laser system for creating single-plane and multiplane arc cuts / incisions in the cornea during...

Intact Vascular stapler device receives European approval
Thursday, April 12, 2012 The European Commission has granted CE mark approval and ISO Certification for Intact Vascular's Tack-it Endovascular Stapler device, used for treating peripheral artery disease...

Boston Scientific pacemakers now available in Europe
Wednesday, April 11, 2012 Boston Scientific has received CE mark approval to launch its Ingenio and Advantio pacemakers, along with Invive cardiac resynchronisation therapy pacemakers (CRT-P), in...

Devon Medical extriCARE wound therapy device wins FDA nod
Tuesday, April 10, 2012 The US Food & Drug Administration (FDA) has granted 510(k) clearance to market Devon Medical Products' extriCARE 2400 negative pressure wound therapy (NPWT)...

Japan clears Abbott's Xience Prime stent system
Tuesday, April 10, 2012 Abbott has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Xience Prime everolimus eluting coronary stent system, designed for treating coronary...

Elekta gets approval to CE mark Agility device
Tuesday, April 03, 2012 Elekta has received clearance to CE mark its Agility multileaf collimator (MLC), a beam-shaping device integrated into the head of a linear accelerator (linac) for treating...

Abbott receives CE mark for PLEX-ID identification system
Monday, April 02, 2012 The European Commission has approved and granted the CE mark (Conformité Européene) to Abbott's PLEX-ID molecular system including three assays (PLEX-ID Viral IC Spectrum, PLEX-ID BAC Spectrum...

Bioline illumigene GBS assay gets Australian clearance
Friday, March 23, 2012 Bioline, a wholly-owned subsidiary of Meridian Bioscience, has received clearance from the Therapeutic Goods Administration (TGA) to commercialise its illumigene Group B Streptococcus (GBS) test...

Cytori Puregraft 850 system wins FDA nod
Tuesday, March 20, 2012 The US Food and Drug Administration (FDA) granted 510(k) clearance for Cytori Therapeutics' Puregraft 850 System, used to contour a patient's body using their own...

Medtronic DBS therapy for epilepsy gets Health Canada licence
Monday, March 19, 2012 US-based medical technology provider Medtronic has received a Health Canada licence for its deep brain stimulation (DBS) therapy for treating patients with refractory...

ImThera sleep apnoea device now available in Europe after CE mark approval
Friday, March 16, 2012 The European Commission has granted CE mark approval for ImThera Medical's aura6000 system, designed for the treatment of obstructive sleep apnoea...