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October 2014

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Ortho-Clinical's Vitros chemistry products HbA1c reagent kit gets CE Mark
20 October 2014 US-based Ortho-Clinical Diagnostics has received CE Mark for the Vitros chemistry products HbA1c reagent kit, an enhanced assay to detect and monitor blood glucose levels over time in...

Boston Scientific secures CE Mark for Accolade pacemaker family
20 October 2014 US-based medical equipment manufacturer Boston Scientific has obtained CE Mark approval for its Accolade pacemaker family of...

Smith & Nephew introduces Evos Mini Plating System for complex long bone fractures
17 October 2014 UK-based Smith & Nephew has introduced the Evos mini plating system for use in complex fractures of the long bones in the arms and legs....

Health Canada grants Class 2 medical device licence for Otoharmonics' Levo tinnitus system
17 October 2014 Health Canada has granted a Class 2 medical device licence to US-based Otoharmonics' Levo system, a personalised neuroscience-based sound therapy developed for use in the temporary relief...

FDA approves Medtronic's CapSureFix Novus MRI SureScan
16 October 2014 The US Food and Drug Administration (FDA) has given approval for Medtronic's CapSureFix Novus MRI SureScan 5076 lead, which will be used with magnetic resonance imaging (MRI)....

Quidel's Lyra Molecular PCR Assay gets FDA clearance for detection of human parainfluenza
16 October 2014 US-based in vitro diagnostics firm Quidel has received 510(k) clearance from US Food and Drug Administration (FDA) to market its Lyra parainfluenza assay, a real-time PCR test, to detect...

VisionCare gets FDA approval for implantable miniature telescope to treat macular degeneration
15 October 2014 US-based developer of advanced visual prosthetic devices VisionCare Ophthalmic Technologies has received US Food and Drug Administration (FDA) approval for its implantable miniature telescope....

Frankfurt University Hospital treats Ebola patient with Aethlon Hemopurifier therapy
15 October 2014 The Frankfurt University Hospital in Germany has used US-based Aethlon Medical's Hemopurifier therapy for the first time to treat a patient infected with the Ebola...

Masimo secures CE Mark for Eve newborn screening application
14 October 2014 US-based Masimo has secured CE Mark appoval for its Eve newborn screening software application for Radical-7 Pulse CO-Oximeters....

Quidel secures FDA 510(k) clearance for lyra adenovirus assay
14 October 2014 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel to market its lyra adenovirus assay, a real-time PCR test for the qualitative detection of human adenovirus...

Covidien secures FDA 510(k) approval for Nellcor Portable SpO2 patient monitoring system
13 October 2014 Covidien has secured US Food and Drug Administration (FDA) 510(k) clearance for the Nellcor Portable SpO2 Patient Monitoring System (PM10N)....

ClearFlow reports positive PRO-ACT trial results of PleuraFlow system
13 October 2014 US-based medical device firm ClearFlow has reported positive results from the Prevention of Retained Blood Outcomes Using Active Clearance Technology trial, (PRO-ACT), a clinical trial...

Endo agrees to acquire Auxilium for $2.6bn
10 October 2014 Ireland's Endo International has entered a definitive agreement with Auxilium Pharmaceuticals to acquire all of its outstanding shares of common stock for around...

SomaLogic and Children’s Hospital Colorado to develop diagnostic tests for childhood diseases
10 October 2014 US-based SomaLogic has entered a partnership with Children’s Hospital Colorado for the development of diagnostic tests for childhood diseases....

Masimo's new rainbow parameter ORI secures CE Mark approval
09 October 2014 US-based Masimo has received CE Mark approval for its oxygen reserve index (ORI), which offers an insight into a patient's respiratory reserve when they are receiving the gas supplementally....

Carestream signs research deal with UBMD for new medical imaging system
09 October 2014 US-based imaging systems provider Carestream Health has entered a research agreement with UBMD Orthopaedics & Sports Medicine to develop new three-dimensional medical imaging system to...

Unilife and Sanofi ink deal for cartridge based wearable injectors
08 October 2014 US-based Unilife has signed a worldwide master services and commercial supply agreement with French drug-maker Sanofi for wearable injectors....

Kubtec secures FDA approval for first breast specimen tomosynthesis system
08 October 2014 Kubtec has received approval from the US Food and Drug Administration (FDA) for its MOZART with TomoSpec, the first and only breast specimen radiography system with tomosynthesis technology....

Claret treats first patient in pivotal US trial of Sentinel cerebral protection system
07 October 2014 US-based Claret Medical has completed treatment of the first patient in its multicentre pivotal SENTINEL trial of the Sentinel cerebral protection system (CPS)....

Panasonic launches new robotic welfare and rehabilitation systems
07 October 2014 Japan-based Panasonic has launched three new products, as part of its age-free solution, at the 41st Home Care and Rehabilitation Exhibition in...

FDA seeks to shut down Pharmaceutical Innovations
06 October 2014 The US Food and Drug Administration (FDA) has sued Pharmaceutical Innovations, a Newark-based maker and distributor of medical accessories and products, over an ultrasound gel that was not...


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