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Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This is a special edition covering trial data presented during the first three days of the American Academy of Orthopedic Surgeons Annual Meeting, held in Las Vegas March 12-16, including presentations on devices from Stryker, Miach, Myoscience, CyMedica, and Reflexion Health.
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The UK government is championing the region of Oxfordshire to become the next global digital health hub post-Brexit. The ambitious plans to develop the UK’s digital health technologies were outlined at a recent event at the House of Commons in London.
Global Device Approvals, Weekly Snapshot: FDA Approves Bard’s Venovo Stent; Abbott’s MitraClip Gets Indication-Expansion; Boston Scientific’s Watchman FLX Earns CE Mark
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Bard’s Venovo venous stent system for symptomatic iliofemoral venous outflow obstruction, FDA added functional mitral regurgitation to the approved labeling for Abbott’s market-leading MitraClip, and Watchman FLX, Boston Scientific’s next-generation left-atrial appendage closer earned a CE Mark in Europe.
Data from the AF-FICIENT I study, presented at the European Heart Rhythm Association in Lisbon, Portugal, support Boston Scientific's development of the Luminize atrial fibrillation ablation catheter. Luminize has built-in digital cameras for visual guidance and sensing electrodes on the balloon to assess real-time vein isolation.
Cardiva Medical believes it's in a unique position to help the growing number of patients who undergo catheter-based cardiovascular procedures requiring relatively large catheters, especially electrophysiology procedures like cardiac ablation. See what Cardiva CEO John Russell said about EP procedures here.
The new indication covers functional mitral regurgitation, also known as secondary mitral regurgitation, which represents two-to-three times as many patients as the primary mitral regurgitation population MitraClip is already labeled for. The approval is supported by results from the COAPT trial, the first randomized trial to show that a mitral-valve repair could improve outcomes in patients with secondary mitral regurgitation.
Device Week, March 14, 2019 – Smith & Nephew Boosts Wound Care Biz; Key Cardiac Trial Results At March Meetings
In this edition of Device Week, Medtech Insight’s Catherine Longworth discusses Smith & Nephew’s $660m acquisition of regenerative medicine company Osiris Therapeutics. And Reed Miller talks about the clinical trial highlights from the recent CRT Meeting in Washington and looks forward to the American College of Cardiology conference next week.
Cardiva Medical is taking advantage of the growing demand for products that safely and quickly close the access sites created for catheter-based electrophysiology procedures and other large-catheter cardiac procedures. The company has a sales staff entirely dedicated to its line of closure devices for multi-site venous closure for 6-12 French inner diameter sheaths, and is investing in clinical trials to show how these devices can improve patients’ recovery time and reduce the risk of complications.
In this week's edition of Medtech Money Flow, ResMed inks a $220M deal to buy Korean respiratory device maker HB Healthcare.
PureTech Health's Akili has announced a $125m partnership with Japanese pharmaceutical company Shionogi to commercialize two of its digital therapeutics in Japan and Taiwan.
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