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Thursday, April 25, 2019

In the Spotlight

BREAKING MEDICAL DEVICE NEWS

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

Video: Vascular Surgeons Chat about Impact of TransCarotid Artery Revascularization on Carotid Treatment

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4/24/19: Phillips-Medisize Expands FDA Compliant Medical Manufacturing Capacity to Support Growing Customer Needs

Phillips-Medisize
Phillips-Medisize reports the facility is FDA 21 CFR part 820 compliant. As a result, this 380,000-square foot facility enhances Phillips-Medisize’s medical manufacturing services with capabilities around molding, stamping, plating and assembly which allows for vertical integration of manufacturing, electronics and connected device solutions all in one site.
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April 24, 2019: Infraredx Announces FDA Approval of Expanded Label Claim for the Makoto ™ Intravascular Imaging System

Infraredx Inc.
“We are very proud of this new milestone that expands the indication for use of the Makoto™ Imaging System and accompanying Dualpro™ IVUS+NIRS catheter to detect both plaques and patients at high risk for dangerous cardiovascular events,” said Nozomu Fujita, President and CEO of Infraredx, a Nipro Company.
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April 24, 2019: LOTUS Edge ™ Aortic Valve System FDA Approval

Boston Scientific
The LOTUS Edge valve system is the only FDA-approved aortic valve that gives physicians the option to reposition and completely recapture the valve once it has been fully deployed. It also features a braided valve frame and an adaptive seal that minimizes paravalvular regurgitation or leaking (PVL) by conforming to the patient's native aortic valve.
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4/23/19: First Patient Enrollment in the Restart DEEP IDE Trial Reports AtriCure

AtriCure
The DEEP IDE trial is intended to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients with persistent or long-standing persistent atrial fibrillation
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4/23/19: GreatCall Introduces the Highest Standard in Medical Alerts with Lively Mobile Plus

GreatCall Inc.
Lively Mobile Plus is a new medical alert device that keeps older adults safe and independent by providing the fastest agent response time, connecting customers to trained 5Star urgent response services with one touch of a button.
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4/23/19: Synaptive Medical to Install World’s First Dedicated Head MRI to Assess Use in the Emergency Department

Synaptive Medical
The purpose of Synaptive’s Evry, a dedicated head MRI, is specifically for imaging patients in situations that require immediate decision making, such as with acute stroke.
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4/23/19: Orthofix M6-C Artificial Cervical Disc – First US Patient Implants Following FDA Approval

Orthofix Medical Inc.
Designed with an artificial viscoelastic nucleus and fiber annulus that mimics the anatomic structure of a natural disc, the M6-C artificial cervical disc device is the only artificial cervical disc available in the U.S. that enables compression or “shock absorption” at the implanted level. The disc also provides a controlled range of motion when the spine transitions in its combined complex movements.
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4/23/19: Samsung Demonstrates Viability of Lower Dose Digital Radiography Algorithm for Pediatric Patients

Samsung
Samsung’s digital radiography (DR) machines – including GC85A and GM85 – incorporate Samsung’s S-Vue™ 3.02, which provides spatially adaptive multi-scale processing and advanced de-noising technology, delivering quality images with a fraction of the dose.
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4/23/19: Surmodics Sublime Guide Sheath Receives FDA 510(k) Approval

Surmodics
The highly flexible, proprietary Xtreme® braid-reinforced Sublime guide sheath is designed to resist kinking and maximize strength while retaining a low profile. The sheath will be available in 5Fr and 6Fr diameters, and 120cm and 150cm lengths.
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Market Reports

Global Trocars Market by Product Type, Type of Tip, Application, End-user, and Region

Market Analysis
3/29/19: Global trocars market is expected to reach $968.5 million by 2024, at a CAGR of 6.8% during the forecast period of 2019 to 2024.
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Global Tuberculosis Diagnostics Market Outlook to 2024 – Nucleic Acid Testing is Expected to Hold the Highest Market Share

Market Analysis
3/19/19: Factors propelling the growth of the market include the increasing burden of tuberculosis and multidrug-resistant tuberculosis, increasing R&D investments, intensive product pipelines, and increasing government initiatives in the emerging markets.
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China Orthopedic Large Joint Device Market Report Suite 2018

Market Analysis
3/19/19: Demand for primary hip replacement will remain strong over the forecast period. Following Western trends, the Chinese hip replacement market is slowly shifting towards an increasing acceptance of ceramic implant balls, HCPE liners and cementless hips implants. The market includes knee replacement devices, hip replacement devices and bone cement and will exhibit rapid growth, despite steady price declines caused by both market competition and pressure from the government.
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Non Profit News

New ACP Guidelines Would Result in Thousands of Unnecessary Breast Cancer Deaths

NON PROFIT
4/8/19: That approach would also likely result in thousands more women enduring extensive surgery, mastectomies and chemotherapy for advanced cancers - and do little to nothing to address overdiagnosis or the harms of screening named in the ACP guidelines.
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New Bill Would Help Address Racial and Ethnic Disparities in Colorectal Cancer Care

NON PROFIT
4/2/19: The bipartisan bill introduced in the U.S. House of Representatives today by Reps. Danny Davis (D-IL) and Brad Wenstrup (R-OH) would provide Medicare coverage for CT Colonography (CTC) screening — also known as virtual colonoscopy.
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ADA’s William T. Cefalu, MD, to Testify on the Rising Cost of Insulin Before the Oversight and Investigations Subcommittee of the U.S. House of...

NON PROFIT
4/1/19: Dr. Cefalu will address the rising costs of insulin, which impact millions of Americans with diabetes who rely on this life-sustaining medication.
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Executives

SynCardia Systems Announces Major Promotions

Executives
4/3/19: Don Webber and Peter Spadaro offer over 60 years of medical device leadership and management experience to SynCardia Systems.
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Timothy Stonesifer Appointed CFO of Alcon

Executives
4/2/19: Timothy Stonesifer is a seasoned executive who joins Alcon with over 29 years of global financial and operational experience. He was most recently with Hewlett Packard Enterprises (HPE), where he served as Executive Vice President and CFO.
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GT Biopharma Completes Management Restructuring

Executives
3/26/19: Anthony J Cataldo has been named Chairman and Chief Executive Officer of GT Biopharma. Mr. Cataldo founded and served as Chairman and Chief Executive Officer at Iovance Biotherapeutics, Inc. He created Iovance with assets purchased from the National Cancer Institute (NCI).
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