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May 2015

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FDA authorises Lumicell to launch feasibility study in breast cancer
22 May 2015 The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to Lumicell to initiate a feasibility study for intraoperative imaging of breast cancer...

Dassault Systèmes set to launch first simulated human heart
22 May 2015 Dassault Systèmes has announced plans to commercially release the first simulated human heart from its Living Heart Project on 29...

Mauna Kea Technologies secures CE Mark to use Cellvizio in minimally invasive laparoscopic surgery
21 May 2015 Mauna Kea Technologies has secured CE Mark for the use of its multidisciplinary confocal laser endomicroscopy platform, Cellvizio, in minimally invasive laparoscopic surgical...

Abbott’s Absorb GT1 stent system secures CE Mark for treatment of CAD
20 May 2015 Abbott has received CE Mark for its Absorb GlideTrack (GT1) catheter for the treatment of patients with coronary artery disease...

DyAnsys develops non-narcotic solution for patients with long-term chronic pain
20 May 2015 US-based medical device maker, DyAnsys has launched a new and effective non-narcotic solution for the treatment of people suffering from long-term chronic...

St Jude releases new data on CardioMEMS HF system
19 May 2015 St Jude Medical has presented new data that supports improved outcomes and cost-effectiveness of the CardioMEMS HF System for the management of Class III heart failure patients at the Heart...

Rosetta introduces two FGFR3 gene mutation assays for bladder cancer
18 May 2015 Rosetta Genomics has launched two new fibroblast growth factor receptor 3 (FGFR3) gene mutation assays for bladder cancer at the ongoing American Urological Association Annual Meeting (AUA 2015)...

Olympus introduces new urology devices at AUA 2015
18 May 2015 US-based medical and surgical products designer Olympus has launched several new urology devices at the ongoing American Urological Association (AUA) Annual Meeting in New Orleans, Louisiana,...

ResMed’s SERVE-HF trial fails to meet primary endpoint
15 May 2015 ResMed's Phase III SERVE-HF trial of adaptive servo-ventilation (ASV) therapy in central sleep apnea and chronic heart failure did not achieve its primary efficacy...

Abbott to develop companion diagnostic tests for AstraZeneca’s asthma drug
15 May 2015 AstraZeneca has signed an agreement with Abbott to develop companion diagnostic tests for identification of patients with severe asthma who may benefit from the investigational biological...

St Jude Medical receives CE Mark approval for Ellipse ICD
14 May 2015 St Jude Medical has received CE Mark approval for expanded labelling for its Ellipse implantable cardioverter defibrillator...

Medtronic’s Arctic Front Advance ST Cryoballoon cleared to treat atrial fibrillation
13 May 2015 Medtronic has been authorised by US Food and Drug Administration (FDA) to use the Arctic Front Advance ST Cryoablation Catheter for the treatment of patients with drug refractory,...

FDA clears StimGuard to start clinical trial for revolutionary OAB treatment
13 May 2015 The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) approval to StimGuard to initiate a US clinical trial for a revolutionary wireless device to...

FDA approves Roche’s cobas KRAS Mutation Test for diagnostic application
12 May 2015 The US Food and Drug Administration (FDA) has approved Roche's cobas KRAS Mutation Test for diagnostic...

N-of-One to provide CNV analysis interpretation for Affymetrix’s OncoScan kit
11 May 2015 N-of-One has signed a business partner agreement to provide copy number variation (CNV) analysis interpretation for Affymetrix's OncoScan assay kit...

China’s Neusoft launches NeuViz 128 CT scanner for global markets
11 May 2015 Chinese medical equipment and services supplier Neusoft Medical Systems has officially launched its new NeuViz 128 CT scanner for global...

Medtronic begins study of 'in-office' insertion of Reveal LINQ cardiac monitor
08 May 2015 Medtronic has started a study to determine the safety and effectiveness of 'in-office' insertion of its Reveal LINQ miniature cardiac...

Dehaier to supply wearable sleep respiratory solutions to Sonqao
08 May 2015 Dehaier Medical Systems is set to supply its sleep respiratory solution systems to China's emerging physical examination chain, Sonqao Health Checkup...

FDA grants 510(k) clearance for Sonendo’s Multisonic Ultracleaning system
07 May 2015 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Sonendo's third generation Multisonic Ultracleaning system for root canal...

Kallistem completes in-vitro production of fully formed human spermatozoa
06 May 2015 Kallistem has successfully produced fully formed human spermatozoa in-vitro, using patient testicular biopsies containing only immature germ cells, also called...

Medicrea launches LigaPASS 2.0 generation band system in US
05 May 2015 The Medicrea Group has launched its next-generation band connector technology for posterior thoraco-umbar fixation in the...


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