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

First Patient Treated in First-in-Man Study of Deep Vein Thrombosis Treatment Designed to Remove Wall-Adherent Clot in Single Session, without Thrombolytic Drugs

Vetex Medical Ltd.

2018-12-18

12/18/18: Vetex Medical Ltd. reports the first patient has been treated in the VETEX (Venous Thrombus Extraction) Study, a first-in-man, multicenter study of the Vetex™ Thrombectomy Catheter.

Monteris Medical Announces Anthem, Inc. Has Developed Clinical Utilization Management Guidelines for its NeuroBlate® System Laser Interstitial Thermotherapy for Refractory Epilepsy

Monteris Medical

2018-12-18

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.

VASCADE MVP Vascular Closure System for Multi-Site Vessel Closure Following Electrophysiology Procedures Receives FDA Approval

Cardiva Medical

2018-12-18

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.

Acquisition of Alicona Imaging GmbH Completed Announces Bruker Corporation

Bruker Corporation

2018-12-18

12/18/18: Alicona Imaging GmbH, a leading provider of optical-based metrology products is located in Graz, Austria.

KCI Enters Into a Performance-Based Agreement with Highmark for the KCI iOn PROGRESS™ Remote Therapy Monitoring Program

2018-12-18

12/18/18: KCI iOn PROGRESS™ Remote Therapy Monitoring Program aims to improve overall patient experience, lower costs through increased engagement & adherence.

ARANZ Medical Raises NZ$5mil New Equity Financing

ARANZ Medical Limited

2018-12-18

12/18/18: ARANZ Medical Silhouette system automates the imaging, measurement and documentation of skin conditions, including chronic wounds.

Aortica Corp. Announces FDA Approves Medtronic Valiant NAVION™ for Inclusion in Starnes’ Physician-Sponsored IDE

2018-12-17

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.

Merit Medical Acquires Assets of Vascular Insights, LLC

Merit Medical Systems Inc.

2018-12-17

12/17/18: Vascular Insights’ primary assets are the ClariVein®IC and ClariVein®OC specialty infusion and occlusion catheter systems.

The MHRA Approves Phase IIa Clinical Trial Application for Tri-Solfen® for Venous Leg Ulcers

Medical Ethics Pty Ltd

2018-12-17

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.

2018-12-17

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.

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.

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

Paul Estrem, CPA Appointmented Senior Vice President and CFO of NorthStar Medical Technologies, LLC

2018-12-18

12/18/18: Estrem holds financial responsibility for the operations of company, reporting to President and CEO Stephen Merrick.

Mark Dunnagan Joins Smartlink Health Solutions as VP of Health Informatics

2018-12-18

12/18/18: In his new role, Mr. Dunnagan will be responsible for product management, software implementation and customer success.

Non-Profit News

ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention

2018-12-17

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...

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.

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