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Archive of industry news from the global medical industry

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September 2014

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Project CURE ships critical medical equipment to West African countries to combat Ebola
12 September 2014 US-based charity Project CURE is shipping examination gloves and other critical medical supplies to West African countries to help stop the spread of the Ebola virus....

FDA clears Medtronic's NC Euphora coronary balloon
12 September 2014 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Medtronic's NC Euphora noncompliant balloon dilatation catheter....

Apollo Hospitals and AliveCor partner for mobile ECG device
11 September 2014 India’s Apollo Hospitals has entered an exclusive collaboration with US-based AliveCor to introduce smartphone-enabled, medical grade and FDA-cleared AliveCor Heart Monitor in India and South...

Medtronic treats first patient in CoreValve Evolut R clinical trial
11 September 2014 Medtronic has successfully treated the first patient in its clinical trial, which is designed to evaluate the safety and effectiveness of the new CoreValve Evolut R System....

Olympus introduces QuickClip Pro Clips for GI endoscopy
10 September 2014 US-based Olympus Medical Systems has launched its 510(k) cleared QuickClip Pro, a haemostasis clip developed for bleed control and defect closure during GI endoscopy procedures....

Marathon launches needle-free device ZiNGO to manage venous access pain
10 September 2014 US-based Marathon Pharmaceuticals has launched ZiNGO (lidocaine hydrochloride monohydrate, 0.5 mg) powder intradermal injection system, to deliver a topical local anaesthetic to manage...

Cynosure acquires assets of Ellman International
09 September 2014 US-based provider of laser and light-based aesthetic treatments Cynosure has acquired the assets of Ellman International for an estimated $13.2m....

Pulsar Vascular to market Codman Neuro's PulseRider device in EMEA
09 September 2014 Codman Neuro, a part of DePuy Synthes Companies of Johnson & Johnson, has signed a distribution agreement with Pulsar Vascular to market and promote its minimally invasive device PulseRider...

Mevion to install S250 proton therapy system at MedStar Georgetown Hospital
08 September 2014 Mevion Medical Systems is set to install its MEVION S250 proton therapy system at the MedStar Georgetown University Hospital, located in Northwest Washington, Columbia, US, to treat adult...

Astute Medical's NephroCheck gets FDA approval to predict risk for acute kidney injury
08 September 2014 US-based Astute Medical has received marketing approval from the US Food and Drug Administration (FDA) for its NephroCheck test, a first-of-its-kind laboratory test to gauge severe acute...

Novocure's TTF-100A system secures high unmet medical need designation in Japan
05 September 2014 The Japanese Ministry of Health and Welfare (MHLW) has granted high unmet medical need designation to Novocure's TTF-100A system, indicated to treat recurrent glioblastoma. ...

GE Healthcare's SenoClaire breast imaging solution obtains FDA approval
05 September 2014 GE Healthcare has received approval from the US Food and Drug Administration (FDA) for its new breast tomosynthesis solution, SenoClaire, which uses three-dimensional imaging technology....

Aethlon Medical receives IRB approval to begin Hemopurifier clinical trials
04 September 2014 Aethlon Medical has received independent internal review board (IRB) approval to start human clinical studies of Hemopurifier therapy at DaVita MedCenter Dialysis in Houston, Texas, US....

St Jude Medical reports positive two-year data from FAME II trial of FFR technology
04 September 2014 US-based medical device firm St Jude Medical has reported two-year data from the FAME II trial of its Fractional Flow Reserve (FFR) guided percutaneous coronary intervention (PCI) over...

GE Healthcare's PET imaging agent Vizamyl gets European marketing authorisation
03 September 2014 The European Commission has granted marketing authorisation for GE Healthcare's Vizamyl (flutemetamol (18F) solution for injection) for positron emission tomography (PET) imaging of beta...

Roche introduces new Cobas automated molecular diagnostic systems
03 September 2014 Roche has launched Cobas 6800/8800 Systems, two integrated and fully automated molecular testing systems for blood and plasma donor screening in markets accepting the CE mark in Europe,...

St Jude Medical reports positive results of FFR technology in NSTEMI patients
02 September 2014 US-based St Jude Medical has reported results from a new multi-centre clinical trial of its Fractional Flow Reserve (FFR) technology in guiding treatment of non-ST segment elevation...

Royal Philips launches new Affiniti ultrasound system
02 September 2014 Royal Philips has launched a new ultrasound system, Affiniti, which allows physicians to treat large volumes of...

Masimo gets CE Mark clearance in Japan for rainbow DCI-mini sensors
01 September 2014 US-based non-invasive patient monitoring technologies manufacturer Masimo has received CE Mark clearance in Japan and limited market release of the rainbow DCI-mini, the first...

Nitto Medic to distribute Nicox's AdenoPlus device in Japan
01 September 2014 Japanese ophthalmic firm Nitto Medic has entered into an agreement with France-based Nicox for the distribution of diagnostic test AdenoPlus in Japan....

August 2014

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HeartSine launches fully automatic AED Samaritan PAD 360P
29 August 2014 HeartSine Technologies has launched the new Samaritan PAD 360P (SAM 360P), a fully automatic automatic external defibrillator (AED)....


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