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Saturday, December 15, 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 by by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit our magazine daily!

Guest Editorial

M. Vince Weaver, MD Vascular Surgeon

From Resistance to Standard of Care: Gaining Acceptance for Technology to Prevent Stroke

12/14/18: Data shows the UroLift System provided significant improvements in BPH symptoms, quality of life, and sexual function for men with an obstructive median lobe.
12/12/18: The EDG Ortho 65mm is the first and only single-use electronic depth gauge. It is designed to more accurately measure length for orthopedic surgical screws, and also mitigate bioburden contamination, a leading cause of surgical site infections. EDGe Surgical’s device provides healthcare professionals, hospitals, and outpatient medical facilities with a digital alternative to analog depth gauges for greater accuracy at a decreased cost, all while mitigating infection risk.
12/12/18: First trans-humeral amputee fitted with osseointegrated LUKE arm post targeted muscle reinnervation (TMR) surgery.
12/11/18: Funds from the round will be used to support product development and a pivotal study of the company’s innovative technology for the treatment of acute decompensated heart failure.
12/11/18: "Our new exciting partnership with LumiThera is fully consistent with the strategy and growth objectives of Miloftalmica, combining innovation and excellence in technology. LumiThera's breakthrough light delivery system is a value added to Miloftalmica's product portfolio," stated Andrea Pagani, Miloftalmica CEO.
12/11/18: The video is part of the company’s national #NoMoreFingerpricks campaign to raise critical awareness about the complexity and seriousness of diabetes and to advocate for innovative technologies like continuous glucose monitoring (CGM) to become the standard in patient care.
12/11/18: “We spend a lot of time listening to physicians to understand their clinical needs. Time and time again, they ask for more treatment options for peripheral artery disease,” said Mark Breedlove, vice president of Cook Medical’s Vascular division. “We’re excited to continue to develop the Zilver PTX line to answer those needs and help more patients around the world.”
12/10/18: The EXCELLENT Registry will enroll up to 1,000 ischemic stroke patients in as many as 50 clinical sites in the United States and Europe. Real-world evidence will be collected on all patients and clots will be preserved and studied to determine how different clot characteristics including size, composition and density may impact or relate to patient comorbidities, clinical outcomes and revascularization rates.
12/10/18: Received 510(k) clearance from the FDA for expanded use of its Monolith® Corpectomy System, providing surgeons with a modular PEEK interbody solution for cervical corpectomy procedures.
12/10/18: The partnership involves multiple initiatives, including the development of new AI-powered algorithms in Bay Labs’ EchoMD measurement and interpretation software suite, the integration of EchoMD algorithms into Edwards Lifesciences’ CardioCare quality care navigation platform, and support for ongoing clinical studies at leading institutions.
12/10/18: Achieves major milestones in its clinical trial programs. In the USA, nearly 30 hospitals are online for ALung’s VENT-AVOID Trial of the Hemolung Respiratory Assist System.
12/7/18: BluePrint reclassified 85 percent of tumors identified as HER2-amplified by IHC/FISH to non-HER2 molecular subtype and clarified the biology of HER2 "equivocal" breast cancer. 46 percent of women under 50 years of age with an intermediate recurrence score identified as MammaPrint Low Risk enabling greater certainty in treatment management approaches
12/7/18: Professor Thomas Zeller, Director of the Department of Angiology at Unversitaets Herzzentrum, Freiburg in Bad-Krozingen, Germany and Principal Investigator of the ENTRAP Study notes, "The Vanguard IEP System is designed to protect patients at high risk for embolization during peripheral angioplasty, such as those with acute limb ischemia, severe calcification, and chronic total occlusions if crossed intraluminally. It is also well suited to protect patients at high risk for complications should embolization occur, such as those with poor distal run-off."
12/6/18: More than 240 leading rehabilitation centers in over 30 countries helped their patients walk 50,000 miles in the EksoGT exoskeleton during rehab sessions— the distance of walking around the world twice.

Market Reports

Bone Grafts and Substitutes

12/14/18: This report is built to visualize quantitative market trends within Orthopedic Devices therapeutic area.

Bone Growth Stimulators 2018 Global Market Analysis & Forecast Model

12/14/18: This report is built to visualize quantitative market trends within Orthopedic Devices therapeutic area.

The Global Clinical Mass Spectrometry Market Through 2019-2023

12/11/18: The clinical mass spectrometry market will register a CAGR of almost 8% by 2023.


12/13/18: Dr. Nozha Boujemaa will oversee the company scientific vision as well as strategies for innovation, development and academic and industrial partnerships for iBiopsy®, the Median Technologies Imaging Phenomics platform.
12/10/18: Dr. Arjun Desai and Jack Campo join INSIGHTEC reported the company today. Both offer knowledge and experience.

Non-Profit News

12/6/18: “The AAOS is encouraged by the recommendations made by the Administration to reform the American health care system through increased choice and competition. We share the mutual goal of delivering high quality care at affordable prices and want to emphasize our support for the following recommendations—many of which the AAOS has long advocated for at both the state and federal level on behalf of our members and their patients.
12/5/18: The surgical procedure, 'Unicondylar knee Arthoplasty', performed as outpatient orthopaedic surgery, by Dr. Vetri Kumar, Consultant Orthopaedic Surgeon, Parvathy Hospital and his team of orthopaedic surgeons is considered as a major milestone in the history of Orthopaedic surgeries in Asia. Parvathy Hospital has named this milestone as M.I.N.O.R.S - Morning In Night Out Replacement Surgeries.