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Archive of industry news from the global medical industry

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October 2014

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Sorin's Memo 3D ReChord gets CE Mark approval
24 October 2014 Italian medical device firm Sorin Group has secured CE Mark approval for its new mitral valve annuloplasty ring, Memo 3D...

Flint Rehabilitation launches music-based hand rehabilitation device MusicGlove
24 October 2014 US-based Flint Rehabilitation Devices has launched MusicGlove, the first hand rehabilitation device approved by US Food and Drug Administration (FDA), for people with stroke or other...

IceCure Medical successfully treats breast cancer patients with IceSense3 cryoablation system
23 October 2014 IceCure Medical has successfully completed treatment of the first two patients in a multi-centred clinical trial using the IceSense3 cryoablation system (exposure to extreme cold temperatures)...

Boston Scientific's CoverEdge surgical leads secure FDA and CE Mark approval
23 October 2014 Boston Scientific have secured US Food and Drug Administration (FDA) and CE Mark approval for its CoverEdge 32 and CoverEdge X 32 surgical leads, which will be used to treat spinal cord...

Aurora Spine signs deal to distribute Sentio MMG nerve mapping system
22 October 2014 US-based spinal implant solutions provider Aurora Spine has entered a worldwide distribution and co-marketing deal with Sentio to distribute the mechanomyography (MMG) nerve mapping system....

Codman Neuro introduces new Spetzler Malis dual irrigating disposable forceps
22 October 2014 Codman Neuro, a part of DePuy Synthes companies of Johnson & Johnson, has introduced new Spetzler Malis dual irrigating disposable non-stick bipolar forceps for use in...

Medtronic launches new interbody spinal fusion devices
21 October 2014 Medtronic has launched its pure titanium coating (PTC) platform of interbody fusion devices designed to ease pain from spinal...

Zeiss Meditec introduces new cataract suite
21 October 2014 Carl Zeiss Meditec, a German medical technology firm, has introduced a new Zeiss cataract suite, which will provide physicians with placement of incisions, the centration of intraocular...

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...

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...

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...

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...

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....

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...

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....


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