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Israeli company Rapid Medical has developed two controllable neurovascular interventional devices for stroke treatment: the Comaneci mesh device for aneurysm treatment, and the Tigertriever stent retriever for treating ischemic stroke.
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Dr Charlie Davie, managing director of UCLPartners, a London-based Academic Health Science Partnership and one of the 15 UK Academic Health Science Networks, updates Medtech Insight on key changes in NHS market access policy this summer.
French start-up LimFlow is developing a percutaneous deep vein arterialization system, designed for installing a stent-graft that shunts blood from a diseased tibial artery into a tibial vein to revascularize the foot of a patient with severe peripheral artery disease.
July 2017 brought 26 approvals from outside the United States, including 14 CE marks in Europe and 12 from five other territories. Almost half of the approvals were for cardiovascular devices; the rest came from eight other categories.
The TRILUMINATE trial will evaluate safety and effectiveness of its Tricuspid Valve Repair System for treating symptomatic moderate-to-severe tricuspid regurgitation. The device is similar to Abbott's successful MitraClip catheter-based device for treating mitral regurgitation.
July was a relatively light month for novel-device approvals by US FDA, but year-to-date volumes remain strong. Spotlighted devices include approval of a new drug-coated balloon and heart valve devices. Here's a roundup from Medtech Insight's Approval Tracker.
Scientists at the Institute of Cancer Research, London have developed a computer-based test that can identify women at high risk of relapsing from breast cancer within 10 years of diagnosis. The new image analysis tool looks at tissue samples taken as part of routine clinical practice and looks at the spatial distribution of immune cells in and around breast cancer, automatically.
A new UK-based innovations award has selected its first batch of winners; the three projects that sprung from the National Health Service will share the £200,000 prize money to help progress their early-stage technologies. The Medtech Accelerator was launched at the end of 2016 as a joint venture between the NHS and regional business partners to provide funding for pioneering medical technologies developed by NHS staff.
Troponin assays are routine tools for diagnosing heart attacks, but there have been challenges on the regulatory front, as testing standards evolve and technology rapidly improves. The agency has called a public meeting for late November to discuss scientific and regulatory challenges for troponin assays and more efficient development strategies.
Timely diagnosis could hold the key to changing the narrative around the emerging hepatitis public health challenge, believes Sushil Devare, Director of Diagnostics Research at Abbott Labs. He explains how Abbott’s HCV Core Antigen test represents an affordable option to nucleic acid tests where the latter is not accessible or unavailable, and also gives Medtech Insight a peek into Abbott’s virus vault under the firm’s global surveillance program.
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