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Wednesday, December 19, 2018

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

12/18/18: Anthem, Inc. has established Clinical Utilization Management Guidelines for LITT allowing access to a minimally invasive surgical option to its beneficiaries with refractory epilepsy when the established medical necessity criteria have been met. This action follows a similar decision by insurance provider Aetna in August 2018.
12/18/18: VASCADE MVP System uses a simple and proprietary delivery system to place a collagen patch on the outside of each vessel puncture site following completion of the procedure.
12/18/18: Alicona Imaging GmbH, a leading provider of optical-based metrology products is located in Graz, Austria.
12/18/18: KCI iOn PROGRESS™ Remote Therapy Monitoring Program aims to improve overall patient experience, lower costs through increased engagement & adherence.
12/18/18: ARANZ Medical Silhouette system automates the imaging, measurement and documentation of skin conditions, including chronic wounds.
12/17/18: This is an ongoing Physician Sponsored IDE study at the University of Washington sponsored by Principal Investigator & Chief of Vascular Surgery Dr. Benjamin Starnes.
12/17/18: Vascular Insights’ primary assets are the ClariVein®IC and ClariVein®OC specialty infusion and occlusion catheter systems.
12/17/18: the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its application for a Phase IIa clinical trial of Tri-Solfen® (for human use the product will be branded as Medi-Solfen®) for the treatment of pain during the surgical debridement of venous leg ulcers.

Retia Medical Receives U.S. Food and Drug Administration Clearance for its Innovative Argos Cardiac Output Patient Monitor

12/17/18: The Argos CO monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for cardiac output monitoring and its derived parameters on patients in the intensive care unit or the operating room.
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.
12/10/18: 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.

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.

Executives

Non-Profit News

The ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention will publish online on Monday, Dec. 17 at 2:00 p.m. ET. To review an...
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.

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