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December 2014

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FDA clears Sorin's Memo 3D ReChord annuloplasty ring
19 December 2014 The US Food and Drug Administration (FDA) has granted clearance for Italy-based medical device firm Sorin Group's Memo 3D ReChord, a semi-rigid annuloplasty ring for mitral valve repair....

Royal Philips agrees to buy Volcano for $1bn
19 December 2014 Dutch firm Royal Philips has signed a $1bn (€800m) agreement to acquire Volcano, a US-based provider of catheter-based imaging and measurement solutions for cardiovascular applications....

Roche introduces PCR molecular diagnostic system
18 December 2014 Swiss drugmaker Roche has introduced an easy to use, molecular diagnostic platform, the cobas Liat...

Cerus secures FDA approval for Intercept blood plasma system
18 December 2014 The US Food and Drug Administration (FDA) has granted approval for Cerus's INTERCEPT Blood System, which is indicated to reduce the risk of transfusion transmitted infections (TTI) from...

diaDexus secures FDA 510(k) clearance for PLAC activity test
17 December 2014 US-based diaDexus has secured 510(k) clearance from US Food and Drug Administration (FDA) for its PLAC Test for lipoprotein-associated phospholipase A2 (Lp-PLA2)...

FDA grants 510(k) clearance for Olympus's Narrow Band Imaging
17 December 2014 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Olympus's Narrow Band Imaging (NBI), a patented endoscopic light technology that enables effective targeting of...

NDSsi launches new multi-node HD video and audio streaming device ExpandOR
16 December 2014 US-based NDS Surgical Imaging (NDSsi) has launched ExpandOR, a multi-node, bi-directional HD video and audio streaming device developed for the healthcare...

HudsonAlpha purchases Illumina’s HiSeq X Ten sequencing system
16 December 2014 US-based non-profit organisation HudsonAlpha Institute for Biotechnology has bought Illumina's HiSeq X Ten sequencing system, which allows the company to produce and analyse genomic data faster...

Stimwave begins evaluating wireless stimulator in Tsunami trial to treat lower back pain
15 December 2014 Medical device manufacturer Stimwave Technologies has started a multi-centre, randomised, double-blind and placebo-controlled clinical trial of its wireless high frequency stimulator to...

Abbott introduces Iridica infectious disease testing platform in Europe
15 December 2014 US-based health care firm Abbott has introduced its new infectious disease testing platform, Iridica, in Europe and other CE Mark recognised...

Quidel's AmpliVue molecular diagnostic test gets FDA clearance
12 December 2014 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Quidel's AmpliVue hand held molecular diagnostic test for the detection of Bordetella...

Aethlon begins enrolling patients in clinical trial of Hemopurifier therapy
12 December 2014 US-based therapeutic devices developer Aethlon Medical has started enrolling patients to support a clinical feasibility trial of Hemopurifier therapy to treat hepatitis C virus...

Roche's PROGNOSIS trial shows high prognostic value of Elecsys blood test
11 December 2014 Swiss global healthcare firm Roche has reported positive results from its multicentre, prospective, double-blind, non-interventional PROGNOSIS trial of Elecsys preeclampsia...

Aurora Spine gets Canadian approval for spinal fusion system
11 December 2014 US-based Aurora Spine has received the Health Canada Medical Device Licence for its ZIP Interspinous Fusion...

Siemens unveils new imaging solutions at RSNA 2014
10 December 2014 Siemens Healthcare has unveiled its new product offerings from its entire imaging and therapy portfolio at the 100th conference of the Radiological Society of North America (RSNA) in Chicago,...

Genomic reports positive results from two feasibility trials of liquid biopsy-based cancer tests
10 December 2014 US-based Genomic Health has reported positive results from its first two feasibility trials evaluating multiple...

Tecomet completes acquisition of Symmetry's OEM business for $450m
09 December 2014 Genstar Capital portfolio firm Tecomet has completed the acquisition of Symmetry Medical's original equipment manufacturing (OEM) Solutions business, for...

Roche introduces new viral load testing assays
09 December 2014 Swiss global healthcare firm Roche has introduced new viral load monitoring assays, cobas HIV-1 and cobas HCV assays, for use on the cobas 6800 / 8800...

Corvida introduces new research study to evaluate Closed System Transfer Device technology
08 December 2014 US-based Corvida Medical has launched a multi-centre research study to evaluate improvements that its Closed System Transfer Device (CSTD) technology could bring to the safe handling of...

BTG to acquire California firm PneumRx for $475m
05 December 2014 Specialist healthcare firm BTG has signed an agreement to purchase PneumRx, a growing firm focused on interventional pulmonology for $475m in a debt-free...

Pfizer launches Novartis's dual bronchodilator for COPD patients in UK
05 December 2014 Novartis's Ultibro Breezhaler, a dual bronchodilator intended for the treatment of chronic obstructive pulmonary disease (COPD) has been launched in the UK by...