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July 2014

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St Jude Medical's FlexAbility ablation catheter gets European approval
23 July 2014 St Jude Medical has received CE Mark approval for its FlexAbility ablation catheter, a new ablation technology used by electrophysiologists, to treat cardiac arrhythmias....

Boston Scientific's Rebel coronary stent system gets approval from FDA
23 July 2014 The US Food and Drug Administration (FDA) has approved US-based Boston Scientific's Rebel platinum chromium coronary stent system used for treatment of coronary artery disease...

FDA grants 510(k) clearance to Summit Medical for additional sterilisation cycles
22 July 2014 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Summit Medical for sterilisation methods on its Instru-Safe instrument protection...

Varian Medical gets FDA approval for Calypso soft tissue Beacon transponder
22 July 2014 The US Food and Drug Administration (FDA) has granted 510(k) clearance to US-based Varian Medical Systems' Calypso soft tissue Beacon transponder that can help improve the precision of...

Brainlab introduces elements automatic brain metastases planning software
21 July 2014 German medical technology firm Brainlab has introduced a new software called 'Elements Automatic Brain Metastases Planning', claimed to simplify stereotactic radiosurgery planning for...

OrbusNeich enrols first patient in MASCOT registry for COMBO dual therapy stent
21 July 2014 Hong Kong-based OrbusNeich has enrolled its first patient in the multinational abluminal sirolimus-coated bio-engineered stent (MASCOT) post-marketing...

FDA approves IBA's new compact gantry clearing way for Proteus ONE
18 July 2014 The US Food and Drug Administration (FDA) has granted marketing approval for Belgium-based Ion Beam Applications' (IBA's) compact gantry beam line...

Blue Belt's Navio surgical system gets FDA marketing approval
18 July 2014 The US Food and Drug Administration (FDA) has granted marketing approval for Blue Belt Technologies' Navio surgical system, patellofemoral joint (PFJ) replacement...

Covidien introduces Emprint ablation system to treat soft tissue tumours
17 July 2014 Ireland-based Covidien has introduced its Emprint ablation system with Thermosphere technology, designed to precisely heat and destroy diseased soft tissue (including liver, lung and kidney),...

BSD Medical begins Phase I/II Hyprosar trial to treat soft tissue sarcoma
17 July 2014 US-based BSD Medical has initiated a Phase I/II trial (Hyprosar) using hyperthermia, delivered using either the BSD-2000 Hyperthermia System or the BSD-500 Hyperthermia System, combined with...

ACell enrols first patient for MatriStem Pelvic Floor Matrix device phase IV trial
16 July 2014 Regenerative medicine firm ACell has enrolled the first patient for a US Phase IV clinical trial to assess the safety and long-term effectiveness of its MatriStem pelvic floor matrix...

Boston Scientific gets CE Mark for new 25mm Lotus valve system
16 July 2014 Boston Scientific has secured CE Mark approval and started the European commercial launch of its new 25mm Lotus transcatheter aortic valve implantation (TAVI)...

FDA approves launch of Titan's Endoskeleton TL device for lateral spinal fusion
15 July 2014 The US Food and Drug Administration (FDA) has granted approval to Titan Spine to commercially launch its Endoskeleton TL system, a spinal fusion solution that uses a lateral...

Veniti secures FDA approval for IDE to begin Virtus trial of VICI venous stent system
15 July 2014 US-based Veniti has received US Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) to initiate the virtus trial of the Veniti VICI venous stent...

Biomet introduces JuggerKnotless Soft Anchor device
14 July 2014 Biomet Sports Medicine has launched the latest product offering in the JuggerKnot Soft Anchor family of all-suture...

Veran Medical releases positive results of lung cancer patient management trial
14 July 2014 US-based firm Veran Medical Technologies has released positive, cost-effective final results from the initial study of its SPiNPerc...

Blue Belt and Smith & Nephew sign deal to bring robotic navigation to Journey Uni knee system
11 July 2014 US-based robotics-assisted surgical firm Blue Belt Technologies has entered into a worldwide commercial agreement with UK-based Smith & Nephew to support the Journey UNI knee system on Blue...

Covidien introduces latest version of EverFlex stent with Entrust Delivery System
11 July 2014 Ireland-based Covidien has launched its EverFlex self-expanding peripheral stent with Entrust Delivery System in Australia and New...

Covidien introduces new Trellis peripheral infusion system
10 July 2014 US-based Covidien has launched its next generation Trellis peripheral infusion system, a pharmacomechanical thrombolysis device that enables focused treatment of blood clots that lead...

AngioScore introduces new AngioSculpt scoring balloon catheters to treat PAD
10 July 2014 Spectranetics's US-based subsidiary AngioScore has introduced its new 200mm length AngioSculpt PTA scoring balloon catheters to treat peripheral artery disease (PAD) above-the-knee...

Ulthera's ultrasound platform device gets FDA approval
09 July 2014 Ulthera has received US Food and Drug Administration (FDA) clearance for its ultrasound platform device to non-invasively treat the chest to improve decolletage lines and...


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