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Friday, January 18, 2019

Medical Device News Magazine

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 by by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit our magazine daily! More here.

Guest Editorial

From Resistance to Standard of Care: Gaining Acceptance for Technology to Prevent Stroke: An Expert’s Experience and Tips

M. Vincent Weaver

by M. Vince Weaver, MD, Guest Editor
Vascular Surgeon

1/18/19: Proceeds from the financing will be used to complete the development of the company’s transcatheter transseptal mitral valve implantation program, which includes regulatory approval trials in Europe to obtain the CE mark and a first clinical trial in the U.S. via an Early Feasibility Study.
1/18/19: The study showed the technology to be about 89 percent accurate in automatic tracking of digested calories. A 14-day study was completed by 27 adult volunteers between the ages of 18-40 years old, 11 men and 16 women.
1/18/19: As part of the investment, which is detailed in a Form 8-K filed with the United States Securities and Exchange Commission on January 14, 2019, Mr. Schwartz also received additional warrants to purchase Company common stock.
1/17/19: The company submitted the Rad@ application with FDA in 2016 and was granted clearance in January 2017. As a result, radiologists can now interpret images and make diagnosis independent of their location.
1/17/19: Baxter’s Sharesource remote patient management platform has logged more than 5 million home peritoneal dialysis treatments globally; milestone is evidence that smarter, more effective innovation is enhancing renal care.
1/17/19: The system's unique design and advanced treatment planning software help enable physicians to avoid healthy tissue and minimize side effects on urinary, bowel, and sexual function that can reduce a man's quality of life.
1/17/19: Embrace TDD clinical study will evaluate the use of the SynchroMed II intrathecal drug delivery system as an alternative to oral opioids for patients with chronic intractable non-malignant primary back pain with or without leg pain.
1/17/19: The multi-center, prospective, non-randomized, single-arm clinical trial included 300 patients from 18 U.S. centers.
1/17/19: HyperArc™ High Definition Radiotherapy (HDRT) is a new type of radiosurgery treatment solution reports Varian.
1/17/19: Net proceeds of the financing will be used primarily to accelerate the Company’s revenue growth through direct expansion of its sales and marketing initiatives.
1/16/19: The STALIF L FLX Lateral Lumbar Integrated Interbody System represents the fourth system of 3D-Printed All-Titanium devices to be launched by Centinel Spine within the last 6 months, in addition to the STALIF C FLX™ Cervical Integrated Interbody, ACTILIF C FLX™ Cervical Interbody, and STALIF M FLX™ Lumbar Integrated Interbody devices.
1/16/19: Bolder Surgical, today announced it has secured $27 million in financing led by River Cities Capital Funds with participation from Westwood Management, Providence Ventures and previous investors. The company also announced a name change to Bolder Surgical as part of a re-branding initiative to better align the company with its long-term vision of a robust product portfolio that expands beyond pediatric care.

Smallest, Lowest Prime Volume, Full-Size Adult* Capiox® Oxygenator Introduced by Terumo Cardiovascular Group

1/16/19: Through Terumo's most advanced product design to date, the new Capiox NX19 oxygenator helps minimize the impact of cardiopulmonary bypass by reducing hemodilution, minimizing inflammatory response, and providing highly efficient gaseous microemboli removal.
1/16/19: The Chocolate Touch® US pivotal study is a prospective randomized study in the US, Europe, and New Zealand that will evaluate patients with disease in the superficial femoral and popliteal arteries in the legs.
1/14/19: New bio-integrative orthopedic fixation material provides unprecedented combination of mechanical strength and natural bone healing in a non-permanent implant.
1/16/19: “Data clearly show that both men and women have significant misconceptions about men’s health, including BPH and the ways to treat the condition,” said Ana Fadich, vice president of Men’s Health Network.
1/14/18: The company will use the proceeds to expand their worldwide commercialization efforts for mi-eye 2™ and mi-ultra™ and to accelerate the development of their minimally invasive product portfolio.
1/11/18: The acquisition includes the L-VARLOCK® Expandable Lumbar Cage which SpineSource has marketed, sold and distributed in the United States since 2016. The acquisition also includes other unique medical devices that SpineSource plans to submit to FDA for potential clearance later this year.
1/10/19: Company reports the new instrument platform and highly validated CorPlex assays promise to revolutionize oncology research and drug development. The progress made since the early access program was initiated in early November 2018 with select industry leaders has validated the performance and promise of the technology, resulting in an accelerated timeline for full launch. The company is now taking orders for shipping by April 1.

Market Reports

Demand for Neurovascular Thrombectomy Devices to Surge on Account of Growing Incidences of Acute Ischemic Stroke

1/17/19: The key players operating in the neurovascular thrombectomy devices market are focused on acquiring companies in order to expand their product offerings and gain maximum share in the terms of revenue in the global neurovascular thrombectomy devices market

Global Dermatology Endoscopy Devices Market Forecast: 2019-2023

1/10/19: The dermatology endoscopy devices market will register a CAGR of almost 9% by 2023.

Pulmonary Drug Delivery Systems Analysis and Forecast 2018-2023

12/27/18: The Pulmonary Drug Delivery Systems market is projected to grow at a CAGR of 5.61% to reach US$51.538 billion by 2023, from US$37.145 billion in 2017.

Non Profit News

Patient Safety Panel to Discuss How Hospitals are Leveraging Open Data to Create Interoperability to Save Patients’ Lives

1/14/19: Since 2013, Patient Safety Movement Foundation has brought competing medtech companies like Zoll, Medtronic, Masimo, Philips, GE Healthcare and Drager together in the name of patient safety.

Pensacola Organ and Tissue Donor to be Honored on 2019 Donate Life Road Rose Parade® Float

12/28/18: Bryan Herrington is being featured among the float's 44 floragraphs, a portrait made of organic materials such as seeds, spices and crushed flowers, that honor organ, tissue and eye donors from across the country.


1/18/19: The leadership pair brings more than 35 years of combined experience commercializing novel technologies in the aesthetic dermatology market and the necessary skillsets to launch and scale the CellFX System and its growing pipeline of applications into the aesthetic dermatology market.
Endologix, Inc. (Nasdaq:ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that it has appointed John...
1/9/19: Dr. Fallon practiced internal medicine for more than 20 years and served as Senior Vice President and Chief Physician Executive at Blue Cross Blue Shield of Massachusetts ("BCBS MA") from 2004 through 2015.