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Friday, November 16, 2018

In the Spotlight


Welcome!  Medical Device News Magazine reports breaking news including clinical trial updates, product launches, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Read with great interest by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit our magazine daily!

11/15/18: Ellipsys, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis, provides physicians and patients access to a unique non-surgical option for arteriovenous (AV) fistula creation, a procedure that had not previously changed in over 50 years.
11/15/18: The Vantage Orian represents a new standard in the premium wide bore 1.5T market with new technology designed to boost productivity, enhance patient comfort and deliver diagnostic clinical confidence.
11/15/18: NICO Corp. to install Viz Recruit, an AI based clinical trial enrollment platform at ENRICH sites to increase enrollment rates and reduce time to randomization in intracerebral hemorrhage (ICH).
11/8/18: Silk Road Medical reports multiple podium presentations at the upcoming VEITHsymposium Nov. 13-17 at the New York Hilton-Midtown will feature the company’s TransCarotid Artery Revascularization (TCAR) procedure.
11/15/18: The company will premiere several new image processing and software advancements during RSNA 2018, for its digital mammography system, ASPIRE Cristalle. The full suite of advancements designed to enhance clinical imaging while lowering dose includes S-View, Iterative Super Resolution (ISR), Tomosynthesis Biopsy, Tomosynthesis Spot, Breast Density Measurement and Comfort Comp*. These features will be available for demonstration at booth #2545 at McCormick Place in Chicago during the annual meeting of the Radiological Society of North America.
11/12/18: Tack Endovascular System®, a first-of-its-kind dissection repair device, is designed to preserve vessel integrity and enhance blood flow following balloon angioplasty.
11/13/18: More intelligence at the modality level enables quality, efficiency and collaboration throughout the entire DR imaging process.
11/8/18: The company is featuring the data in multiple presentations facilitated by lead investigators. GREAT is the largest industry-sponsored registry of aortic stent grafts with enrollment and follow-up data from over 100 sites across 13 countries.
11/9/18: VentureMed Group will be exhibiting at VEITHsymposium November 14 - 17, 2018 in New York City.
11/13/18: Embolic Prevention System will be featured in several podium presentations during the upcoming VEITHsymposium, which is being held November 13-17 in New York.
11/12/18: In this study, researchers evaluated the company’s AI-driven HART AKI test on 889 patients undergoing cardiac catheterization in Massachusetts General Hospital’s (MGH) Catheter Sampled Blood Archive in Cardiovascular Disease (CASABLANCA) study.
11/12/18: The company is developing the world’s first device to help pediatricians instantly and accurately diagnose middle ear infections (Otitis Media) in children and adults.
11/12/18: Agili-C™ Implant procedure was performed by site PI Eric J. Strauss, MD, orthopedic surgeon,NYU Langone Health's Sports Medicine Center NYC.
11/12/18: FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, which show unloading the left ventricle with Impella CP® for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately.
NeoLight, an empathy-driven medical device company that designs, engineers, and manufactures technologies to treat infants with life-threatening medical conditions, announces today interim data from...
11/12/18: PREVENA™ Incision Management System reduced postsurgical wound complication potential in patients recovering from oncological breast surgery and breast reconstruction, respectively.
11/9/18:The world’s first fully absorbable, patch-based large-bore percutaneous closure device is now available to European physicians and patients.
11/9/18: The company announced the release of the 2019 Fee Schedule from the U.S. Centers for Medicare & Medicaid Services (CMS) that should support broad use of its WatchPAT technology.

Groundbreaking Study of the JETi Thrombectomy System Proves to be a Safe and Effective Treatment of Deep Venous Thrombosis

No VTE/DVT Study Published to Date Has Had an Initial Goal of Demonstrating Efficacy in a Single Session Setting, Without the Crutch of Post-Procedural Lytic Infusion. Read more.

11/8/18: The SPYRAL HTN-ON MED Trial is the latest prospectively powered, randomized, sham-controlled study within the broader Medtronic SPYRAL HTN Global Clinical Program, and will evaluate a patient population comparable to what physicians typically encounter in daily practice - patients with uncontrolled blood pressure taking multiple anti-hypertensive medications.
11/8/18: The study was presented today as a poster1 at the Diabetes Technology Meeting in Bethesda, Maryland by Andreas Stuhr, M.D., Head of Global Medical Affairs and lead author. It examined the impact of usage of the CONTOUR®DIABETES app on the likelihood of hypo- and hyperglycemic events. It also assessed testing frequency in people with diabetes for the first 30 days and after 180 days of app use.
11/7/18: MedicalTek believes there is a common belief that 3D visualization provides a better image to minimally invasive surgery with depth perception. They report a better solution is the 3D image with adjustable disparity, which provides the customized 3D effects to serve the very different eye movement and visual perception of each surgeon at very different operating environments.
11/7/18: “This long-term data marks a paradigm shift in pulmonary embolism protection and is exactly why we brought the BTG Sentry to market,” said BTG Chief Commercial Officer John Sylvester.

Market Reports

Global Medical Lasers System Market Analysis 2017-2018 and Forecast to 2026

11/9/18: Medical Lasers System Market accounted for $1.87 billion in 2017 and is expected to reach $6.11 billion by 2026 growing at a CAGR of 14.1% during the forecast period.

The Global Spinal Fusion Devices Market is Forecast to Grow at a CAGR of 3% During 2018-2024

11/4/18: High cost of treatment is hampering growth outlined in this report.

Global Ureteroscopes Market Outlook 2018-2024

11/2/18: The report predicts the global ureteroscopes market to grow with a CAGR of 4.3% over the forecast period of 2018-2024. The study on ureteroscopes market covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific and RoW for the period of 2016 to 2024.

Service Robotics Worldwide Markets to 2026

11/1/18: According to this report, the Global Service Robotics market accounted for $10.77 billion in 2017 and is expected to reach $44.68 billion by 2026, growing at a CAGR of 17.2% from 2017 to 2026.

Cardiac Biomarker Diagnostic Test Kits Market Would Reach US$ 2,540.8 Mn by 2028

10/16/18: the global cardiac biomarker diagnostic test kits market is projected to expand at a CAGR of 5.1% during the forecast period 2018-2028 and reach US$ 2,540.8 Mn by the end of 2028.

Urolithiasis Management Devices Market to Earn US$1.78 Billion by 2024 With Rising Number of Geriatric Population

10/5/18: As per the TMR report, the global urolithiasis management devices market is estimated to earn US$1.78 bn by the end of 2024. The market is presumed to expand to 4.5% CAGR within the forecast period of 2016 to 2024.

Global Left Ventricular Assist Device Market Outlook to 2023

10/5/18: The Global Left Ventricular Assist Device Market was worth 1024 Million USD in 2017 and it is estimated to grow to 1860 Million USD by 2023 with a CAGR of 10.46% between 2017 and 202

Global In Vitro Toxicology Testing Market 2018-2024 by Toxicology Endpoints, Industry Type, and Regions

10/5/18: The global in vitro toxicology testing market is estimated to witness a CAGR of 8.2% during the forecast period 2018-2024.


11/15/18: BMW i’s marketing manager, Sophie Chiappe said: “The finalists showcase the innovation challenges that businesses face and the technological advancements that will lead the way. Technology has to be at the forefront of business development. It is so important to celebrate this innovation and the individuals driving this forward. We are delighted to be partnered with the UK Tech Founder Awards and celebrate the entrepreneurial stories behind the individuals changing the future of the technological landscape.”
11/7/18: NDA Partners Chairman Carl Peck, MD notes Geiger is a senior Clinical Operations professional with extensive experience in clinical trial management, including managing operations and trials focused on oncology and CNS development in the US, Australia, Latin America, Europe, and Asia, has joined the firm.
11/6/18: All resolutions put to shareholders were duly passed during the Annual General Meeting ("AGM") held on November 5, 2018 at 14:00 PDT.
11/6/18: “Justin is recruiting and securing the best possible team to develop and commercialize our game-changing device,” said Dr. Nazmi Peyman, Founder and Chief Medical Officer for SynerFuse. “The future is bright for our modulation-based pain management solution, and this is good news for patients, surgeons, payers and alike.”

Non-Profit News

11/15/18: “Traditional cigarettes are an often-lifelong habit with major health implications that usually begins in adolescence," said American College of Cardiology President C. Michael Valentine, MD, FACC,
11/9/18: Dr. Aller, who is a practicing optometrist and Visiting Scholar at the UC Berkeley School of Optometry, highlighted how VTI’s unique center distance, extended depth of focus multifocal lens design continues to show promise in managing myopia in children.
11/9/18: Mammography screening is not a primary factor in plummeting breast cancer deaths and reinforces the long-proven fact that Mammography Saves Lives™ according to a published study reports the American College of Radiology.
11/6/18: In the guideline, bradycardia is defined as a heart rate of less than 50 beats per minute, compared to a normal heart rate of 50-100 beats per minute.