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Medical Device Technology
Boston Scientific receives FDA approval for IntellaTip MiFi XP ablation catheter
Catheters : 22 August, 2013
Boston Scientific continues to expand its electrophysiology (EP) offerings with US Food and Drug Administration (FDA) approval of its IntellaTip MiFi XP catheter and 510(k) clearance of its Zurpaz 8.5F steerable sheath.
 
Ambulatory infusion pump feeds world record attempt for longest endurance trip on artificial nutrition
Pumps and dispensers : 21 August, 2013
Justin Hansen – 'The Gutless Kayaker' - will be relying on the CME Medical Bodyguard 323 Ambulatory Infusion Pump for the delivery of Total Parenteral Nutrition (TPN) for 32 days non-stop as he undertakes a 420-mile kayaking trip to raise money for bowel cancer research.
 
St Jude Medical acquires Endosense to add to electrophysiology portfolio
Catheters : 20 August, 2013
St Jude Medical acquires Endosense, a Switzerland-based company that has pioneered contact-force measurement in catheter ablation.
 
Medtronic submits first PMA module for IN.PACT Admiral drug-eluting balloon
Balloons : 19 August, 2013
Medtronic is submitting the company's first pre-market approval (PMA) module to the US Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon.
 
St Jude Medical receives FDA approval of MediGuide Enabled Ablation Catheters
Catheters : 16 August, 2013
St Jude Medical receives US Food and Drug Administration (FDA) approval and first use of MediGuide Enabled Ablation Catheters.
 
Man with SynCardia Total Artificial Heart surpasses two years of support
Cardiac devices and equipment : 16 August, 2013
36-year-old Frenchman Frederic Thiollet, surpasses two years of support with the SynCardia temporary Total Artificial Heart and says he is enjoying each and every day.
 
BD launches plastic prefillable syringe to deliver large volume injectable drugs
Syringes : 15 August, 2013
BD Medical is launching BD Sterifill Advance, a new prefillable polymer syringe specially engineered to deliver large volume injectable drugs by way of intravenous infusion.
 
EPGL Medical invents smart epidural needle, nerve ablation and trigger point treatment devices
Needles : 14 August, 2013
Company engineers from EP Global Communications and EPGL Medical invents three smart medical devices which have similar purpose; to give physicians advanced situational awareness during critical procedures and thus cutting cost to providers and risk to patients.
 
Covidien launches RF ablation catheter to eliminate need for multiple endoscope introductions
Catheters : 14 August, 2013
Covidien is expanding the company's portfolio of radiofrequency ablation (RFA) catheters with the launch of the Barrx Channel RFA Endoscopic Catheter for treating Barrett's esophagus and certain gastrointestinal bleeding disorders.
 
World's first Cloud-based wireless ECG receives CE certification
Cardiac devices and equipment : 12 August, 2013
WEB Biotechnology, which makes the world's first cloud-based continuous ECG monitor called the Spyder, is receiving CE certification for the company's ECG monitoring solution.
 
Cook finalises patient enrollment for study to treat arterial occlusions from the retrograde tibiopedal approach
Cardiac devices and equipment : 09 August, 2013
Cook Medical completes patient enrollment in a study evaluating a technique for achieving vascular access via below-the-knee arteries. The new access technique could be used in treating peripheral arterial disease (PAD), including patients with critical limb ischemia (CLI).
 
Stryker Interventional Spine launches two minimally invasive devices to treat facet joint pain
Cannulae : 08 August, 2013
Stryker Interventional Spine receives clearance of 510(k)s for two additional products to the company's portfolio - Venom RF Cannula and Venom Electrode are designed to provide an effective and minimally invasive treatment for facet joint pain.
 
Medtentia Helix Ring for Mitral Valve Repair continues to achieve all objectives in approval study
Cardiac devices and equipment : 05 August, 2013
Surgeons at Helsinki University Hospital led by Prof Werkkala continue to recruit patients for the official second phase of the clinical approval study evaluating the safety and efficacy of the 'Medtentia Helix Ring in Adults Undergoing Mitral Valve Repair Surgery'.
 
Study indicates benefits of balloon sinus dilation compared with traditional sinus surgery for chronic sinusitis
Balloons : 26 July, 2013
Results from a randomized study demonstrate the benefits of non-surgical balloon sinus dilation procedures compared to traditional sinus surgery for chronic sinusitis patients.
 
ETView Medical agrees distribution deal with MEDITRADE for Slovakia, Czech Republic and Poland
Tubes and tubing : 23 July, 2013
ETView Medical is entering into an exclusive distribution agreement with MEDITRADE which allows CTI to market ETView's VivaSight products which combine airway ventilation tubes with integrated continuous high resolution airway imaging for patient airway management and lung isolation capability in Slovakia, Czech Republic and Poland for a period of two years.
 
Sanford Aberdeen Medical Center performs first robotic-assisted stent placement in acute heart attack patient
Balloons : 19 July, 2013
Sanford Aberdeen Medical Center in Aberdeen, South Dakota, USA, became the first hospital to perform a Robotic Angioplasty for a patient with an acute heart-attack, achieving a far better door-to-balloon time than the national standard.
 
Zoll CPR technology supports new AHA recommendations for improving CPR quality
Cardiac devices and equipment : 19 July, 2013
Zoll Medical's CPR technologies and data products are aiming to help organizations meet the American Heart Association (AHA) consensus statement recommending an increased focus on improving CPR quality during resuscitation from sudden cardiac arrest (SCA).
 
Hansen Medical reinforces collaboration with Philips to develop robotic systems for endovascular interventions
Catheters : 18 July, 2013
Hansen Medical, a global leader in intravascular robotics, and Philips are reaching an important milestone in their long-term collaboration by securing certified compatibility - article 12 of the Medical Device Directive 93/42/EEC, as amended by 2007/47/EC - between Hansen Medical's Magellan Robotic System and Philips' Allura interventional X-ray systems.
 
Zoll acquires the assets of Lifebridge Medizintechnik
Cardiac devices and equipment : 17 July, 2013
Zoll Medical purchases the assets of Lifebridge Medizintechni, based in Ampfing, Germany.
 
Sorin signs supply agreement for Boston Scientific's Lotus valve system
Cardiac devices and equipment : 16 July, 2013
Sorin signs a supply agreement for the manufacturing of certain components of the Lotus Aortic Valve System, Boston Scientific's second-generation TAVR (Transcatheter Aortic Valve Replacement) technology.
 
Welch Allyn unveils two connectivity-ready electrocardiograph devices in the USA
Cardiac devices and equipment : 16 July, 2013
Welch Allyn is introducing two connectivity-ready electrocardiograph devices in the USA.
 
Boston Scientific launches guide extension catheter in USA and Europe
Catheters : 15 July, 2013
Boston Scientific receives US Food and Drug Administration 510(k) clearance and CE Mark approval for the Guidezilla Guide Extension Catheter and has launched the device in the USA and Europe.
 
Vention Medical acquires RiverTech Medical
Tubes and tubing : 10 July, 2013
Vention Medical acquires RiverTech Medical, a leading supplier of polyimide tubing, braided polyimide, composite tubing and wire coatings for numerous medical devices and medical device applications.
 
CorMedix receives CE Mark for catheter lock solution
Catheters : 08 July, 2013
CorMedix receives CE Mark approval for Neutrolin, a catheter lock solution, for patients with central venous catheters on haemodialysis secondary to advanced chronic kidney disease.
 
ZOLL acquires the assets of CoAxia
Catheters : 02 July, 2013
ZOLL Medical purchases the assets of CoAxia of Maple Grove, Minnessota, USA, an early revenue stage medical device company that provides catheter-based perfusion augmentation therapies to improve outcomes for patients with cerebral ischemia resulting from vasospasm, following subarachnoid haemorrhage.
 
St Jude Medical launches wireless MRI-conditional pacemaker in Japan
Pacemakers : 01 July, 2013
St Jude Medical receives regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and launch of the Accent MRI Pacemaker and the Tendril MRI lead.
 
First implant of Boston Scientific Vitalio pacemaker is performed in Europe
Pacemakers : 28 June, 2013
The first patient implant of the Boston Scientific VITALIO pacemaker is performed at ZGT Hengelo in Hengelo, the Netherlands.
 
GPS-like technology for CPR is shown to double survival from cardiac arrest
Cardiac devices and equipment : 28 June, 2013
ZOLL Medical Corporation, reports that survival from one of the leading causes of death in the USA, out-of-hospital cardiac arrest, more than doubled from 26 to 56 percent when paramedics in Mesa, Arizona utilised ZOLL's CPR feedback technology in combination with scenario-based training.
 
Multicentre European study to evaluate treatment system for Persistent Atrial Fibrillation
Cardiac devices and equipment : 27 June, 2013
CardioFocus' HeartLight technology becomes the focus of a multicentre European clinical study for the treatment of drug-refractory persistent AF.
 
Boston Scientific pacemaker family adjusts pacing to respiration
Pacemakers : 27 June, 2013
Boston Scientific is launching a new family of pacemakers in Europe which monitor respiration, adjust pacing accordingly, and support insight into the patient's overall heart failure status.
 
St Jude Medical gains CE Mark approval of multipoint pacing CRT-D
Cardiac devices and equipment : 25 June, 2013
St Jude Medical receives CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D).
 
Clinical study validates pacemakers for sleep apnea monitoring against polysomnography
Pacemakers : 25 June, 2013
Sorin Group reveals the results of the DREAM clinical trial.
 
First US implant of CRT-D system is implemented for RESPOND CRT IDE clinical trial
Cardiac devices and equipment : 24 June, 2013
Sorin Group announces the first US implant of the company's PARADYM SonR CRT System for the RESPOND CRT IDE Clinical Trial.
 
South Shore Hospital standardises on Masimo SET pulse oximetry to improve patient monitoring
Pulse oximeters : 21 June, 2013
South Shore Hospital is converting to Masimo SET pulse oximetry and sensor technologies which virtually eliminate false alarms (Ref 1) and increases a clinician's ability to detect life-threatening events (Ref 2) - helping to substantially contribute to improved patient outcomes and patient safety.
 
Cook Medical launches new wire guided oesophageal balloon to treat GI strictures
Balloons : 21 June, 2013
Cook Medical is making the company's Hercules 3 Stage Wire Guided Esophageal Balloon available to otolaryngologists to treat patients with gastrointestinal (GI) strictures.
 
Sorin Group launches family of pacemakers with sleep apnea monitoring
Pacemakers : 20 June, 2013
Sorin Group receives CE mark approval and the European commercial launch of the REPLY 200 family of pacemakers featuring Sleep Apnea Monitoring (SAM).
 
BMI Southend Private Hospital installs advanced cataract laser system
Laser systems : 20 June, 2013
BMI Southend Private Hospital, the specialist eye hospital in Essex, becomes one of the first UK hospitals to offer patients the advanced LensAR Femtosecond Cataract Laser by Topcon.
 
HeartWare receives conditional approval from FDA to enroll supplemental patient cohort in destination therapy trial
Cardiac devices and equipment : 19 June, 2013
The US Food and Drug Administration (FDA) grants conditional approval to an IDE (Investigational Device Exemption) Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the company's pivotal, Destination Therapy clinical study.
 
Study shows Covidien embolization device offers safe and effective treatment of large aneurysms
Cardiac devices and equipment : 18 June, 2013
Covidien reports that the final results of the PUFs (Pipeline for Uncoilable or Failed Aneurysms) clinical study of the company's Pipeline embolization device have been published in the June issue of Radiology (Ref 1) which is the official peer-reviewed medical journal of the Radiological Society of North America.
 
IntriCon reveals strategic restructuring plans to accelerate growth
Wireless equipment : 17 June, 2013
IntriCon is unveiling a global strategic restructuring plan designed to accelerate the company's future growth by focusing resources on the highest potential growth areas and reduce costs by approximately $3.0 million annually.
 
St Jude Medical receives FDA approval of high-voltage devices with added safety features
Cardiac devices and equipment : 12 June, 2013
St Jude Medical receives US Food and Drug Administration (FDA) approval of its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
 
ETView Medical signs airway ventilation tube distribution deal with Clinical Technologies
Tubes and tubing : 11 June, 2013
ETView Medical is entering into an exclusive distribution agreement with Clinical Technologies (CTI).
 
CardioNet enters into National Provider Agreement with UnitedHealthcare Insurance
Cardiac devices and equipment : 11 June, 2013
CardioNet has entered into a three-year National Provider Agreement with UnitedHealthcare Insurance Company, covering all of CardioNet's monitoring modalities, including Mobile Cardiac Outpatient Telemetry (MCOT).
 
Non-invasive cardiac support pump shows circulation benefits after SCA
Cardiac devices and equipment : 07 June, 2013
A paper published in Critical Care Medicine reports the likelihood of achieving a return of spontaneous circulation (ROSC) after sudden cardiac arrest (SCA) is 62 percent greater when ZOLL Medical's AutoPulse Non-invasive Cardiac Support Pump is used to deliver CPR chest compressions.
 
Ventana colloborates with Barco to revolutionize digital pathology viewing experience
Displays and monitors : 05 June, 2013
Ventana Medical Systems, a member of the Roche Group, signs a worldwide agreement with healthcare imaging expert Barco to provide Barco's leading diagnostic and clinical review display systems for use with the Ventana Virtuoso image and workflow management system, offering a best-in-class, turnkey image viewing solution.
 
Medtronic to submit first module of US approval application for novel peripheral angioplasty device to FDA
Balloons : 04 June, 2013
Medtronic declares that enough patients have been enrolled in the company's clinical studies of the IN.PACT Admiral drug-eluting balloon to support the company's US regulatory approval submission of the novel angioplasty device, which is designed to treat atherosclerotic lesions in the superficial femoral artery.
 
Prefillable syringe offers advanced glass technology for biopharmaceutical injectable drug delivery
Drug delivery equipment : 04 June, 2013
BD Medical, a segment of BD (Becton, Dickinson and Company) is launching BD Neopak, a new glass prefillable syringe system specifically engineered for the administration of biopharmaceutical injectable drugs.
 
Pulse oximeters receive 510(k) clearance with labelling for use in newborn screening for CCHD
Pulse oximeters : 29 May, 2013
Covidien's Nellcor pulse oximetry portfolio facilitates quick, noninvasive screenings for CCHD.
 
Arcolectric partners BioCote to offer antimicrobial switches
Switches : 28 May, 2013
Arcolectric, an Elektron Technology connectivity brand, is partnering with BioCote to offer a range of switches and covers with built in BioCote antimicrobial technology, providing integral protection from a wide range of micro-organisms, including bacteria, mould and fungi.
 
Clinical data shows benefits of parachute ventricular partitioning device
Catheters : 24 May, 2013
CardioKinetix is reporting results of a meta-analysis study of the first-of-its-kind catheter-based Parachute Ventricular Partitioning Device.
 
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