Yearly Archives: 2018

MEDI FUTURES Raises US$5M Funding Led by Samho Green Investment

12/28/18: Strengthening of global strategy based on solid sales growth expected to accelerate FDA and CFDA approvals.

Alma Lasers, GmbH Receives Notice of Completion of Inquiry from FDA for FemiLift™ Pixel CO2 System

12/28/18: "We take compliance with FDA regulatory requirements seriously and we took immediate action following the July notice to work with the FDA to review and resolve their questions," said Lior Dayan, CEO of Alma Lasers. "We are pleased to have collaboratively brought this matter to a close, and we will continue to ensure that all of our products are promoted according to FDA regulations."

Medical Device Developer EnClear Therapies Spins out of QurAlis

12/28/18: “During our discovery process of causative gene mutations in ALS, we realized that some of the mutated proteins transcribed from these genes cause not only loss of function issues but that the mutations make them in fact specifically toxic and that this toxicity spreads through the brain and spinal cord causing neuronal death,” said Kasper Roet, Ph.D., CEO of QurAlis and Co-Founder of EnClear.

First Patients Are Treated in the United States with OrbusNeich Teleport® Microcatheter

12/27/18: The OrbusNeich® Teleport Microcatheter (Teleport), recently received U.S. Food and Drug Administration 510(k) clearance.

Boston Scientific Exercises Option to Acquire Millipede, Inc.

12/27/18: Acquisition will expand structural heart portfolio to include transcatheter mitral annuloplasty repair system.

University of Queensland to Install 15 Canfield VECTRA WB360 Imaging Systems

12/27/18: VECTRA WB360 Imaging Systems works by capturing a 3D total body image in milliseconds, significantly improving lesion surveillance, increasing patient comfort, while greatly reducing appointment times and healthcare costs.

Concussion Safety Upcoming Segment on “Information Matrix” to be Hosted by Laurence Fishburne

12/26/18: “Information Matrix,” featuring Laurence Fishburne, covers a wide range of topics for the general public and has received numerous awards and accolades for its educational content.

JLK Inspection Introduces AI-based All-in-One Medical Image Diagnosis System, AIHub

12/26/18: Pioneering predictive medical image diagnosis platform, the AIHub, has the ability to detect and monitor more than 30 medical conditions from 14 regions of the body with pinpoint accuracy.

Nativis Voyager Device: Publication of Study in Patients with Recurrent Glioblastoma Announced by Nativis

12/19/18: “We are excited to have this publication accepted by CNS Oncology in conjunction with our internationally recognized clinical trial partners, led by Charles Cobbs, MD and Santosh Kesari, MD PhD,” stated Chris Rivera, Nativis Chief Executive Officer. “The data in this early feasibility study not only suggest that the Nativis Voyager device is safe for the treatment of rGBM, but also that further studies to explore clinical utility are warranted.”

Reprieve Cardiovascular™ Announces New Clinical Study Results TARGET II Study

Professor Piotr Ponikowski, Professor of Cardiology at Wroclaw Medical University, 4th Military Hospital in Wroclaw, Poland, presented early positive results from the TARGET II Study.

AbbVie and Voluntis to Develop Companion Digital Therapeutics

12/19/18: Both companies will leverage Voluntis’ proven Theraxium technology to make this new solution available to patients and providers in the United States.

First Patient Enrolled in the Phase 3 ReCePI Study

12/19/18: ReCePI is designed to evaluate the efficacy and safety of INTERCEPT RBCs in patients requiring transfusion for acute blood loss during complex cardiac surgery. A total of 600 patients are expected to be enrolled in up to 20 participating sites in the U.S.

STAR-I Trial: iSTAR Medical’s MINIject Maintains Exceptional Results in First-in-Human Trial One Year Post-Surgery

12/19/18: STAR-I trial demonstrated that the implantation of MINIject resulted in an average 32.6% IOP reduction to a mean of 15.6 mmHg at one year.

Medtronic Completes Acquisition of Mazor Robotics

12/19/18: Acquisition of Mazor Robotics shareholders will receive $58.50 per American Depository Share, or $29.25 per ordinary share, in cash.

Vertex Medical: 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

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.

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

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.

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

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

Acquisition of Alicona Imaging GmbH Completed Announces Bruker Corporation

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

ARANZ Medical Raises NZ$5mil New Equity Financing

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

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

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

Vascular Insights’ primary assets are the ClariVein®IC and ClariVein®OC specialty infusion and occlusion catheter systems.

Argos Cardiac Output Patient Monitor Receives U.S. Food and Drug Administration Clearance

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.

The MHRA Approves Phase IIa Clinical Trial Application for Tri-Solfen for Venous Leg Ulcers: Product to be Branded as Medi-Solfen

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.

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

The MedLift Study provided clinical evidence to support the safety and efficacy of the UroLift System treatment for BPH, or an enlarged prostate, involving a median lobe obstruction.

Renerva Receives $2.4 Million DoD Award to Advance Its Peripheral Nerve Matrix Technology to the Clinic

12/14/18: Renerva's first product, peripheral nerve matrix (PNM), is an injectable gel derived from porcine tissue that promotes and supports repair and regeneration in injured peripheral nerves. The award will enable Renerva to complete its preclinical program and begin human clinical trials.