In the Spotlight

BREAKING MEDICAL DEVICE NEWS

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

NeoTract’s UroLift® System 12-Month Study Published in Prostate Cancer and Prostatic Diseases

Teleflex Incorporated

2018-12-14

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.

EDGe Surgical Secures $4 Million in Series A Financing

EDGe Surgical Inc.

2018-12-12

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.

Next Step Bionics & Prosthetics Unveils World’s First Osseointegrated LUKE Arm Prosthesis

Next Step Bionics & Prosthetics

2018-12-12

12/12/18: First trans-humeral amputee fitted with osseointegrated LUKE arm post targeted muscle reinnervation (TMR) surgery.

WhiteSwell Announces $30 Million Financing for New Therapeutic Approach to Acute Decompensated Heart Failure

2018-12-11

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.

LumiThera Announces a Distribution Agreement for the Valeda Light Delivery System with Miloftalmica in Italy

2018-12-11

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.

Hidden Camera Video Generates Empathy for Those Living with Diabetes

2018-12-11

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.

Cook Medical receives FDA Approval for First 5 mm Diameter SFA Drug-Eluting Stent

2018-12-11

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.”

CERENOVUS Launches Largest Global Registry to Study Stroke-Inducing Blood Clots Removed by Thrombectomy

2018-12-10

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.

NuVasive Grows Cervical Spinal Interbody Portfolio With PEEK Corpectomy Implant

2018-12-10

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.

Bay Labs Announces Collaboration with Edwards Lifesciences to Utilize AI Software to Improve Heart Disease Detection

2018-12-10

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.

ALung Announces Significant Progress in its Hemolung Clinical Trial Programs

ALung Technologies

2018-12-10

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.

New Studies Show MammaPrint® and BluePrint® Tests Provide Greater Clarity Regarding Risk of Breast Cancer Recurrence and Classifications for Treatment

2018-12-07

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

Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection

Contego Medical

2018-12-07

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."

Worldwide Adoption of Ekso Bionics® EksoGT™ Exoskeleton Allows Stroke and Spinal Cord Injury Patients to Take 100 Million Steps to Date

2018-12-06

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

Market Analysis 2018-12-14

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

Market Analysis 2018-12-14

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

Market Analysis 2018-12-11

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

Executives

Median Technologies appoints Dr. Nozha Boujemaa as Chief Science and Innovation Officer

2018-12-13

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.

INSIGHTEC Announces Expansion of Executive Management Team

2018-12-10

12/10/18: Dr. Arjun Desai and Jack Campo join INSIGHTEC reported the company today. Both offer knowledge and experience.

Non-Profit News

AAOS Encouraged by Administration’s Plan to Promote Healthcare Competition

2018-12-06

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.

Parvathy Hospital Performs Asia’s First Day Surgery for Joint Replacement on a Senior Citizen

2018-12-05

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.

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