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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 practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit the magazine daily! More here.

Video: Vascular Surgeons Chat about Impact of TransCarotid Artery Revascularization on Carotid Treatment

View here.

Over 500,000 Men Globally Suffer from Stress Urinary Incontinence (SUI). The Newly Launched Next-Gen AdVance XP Male Sling System by Boston Scientific Includes a Redesign Intended to Improve Ease of Placement and Stability, and is Available in Longer Sling Lengths

Dr. Brian Christine, Director of Erectile Restoration, Prosthetic Urology and Male Genital Aesthetic Surgery, Urology Centers of Alabama on the Value of the Advance XP Male Sling System for Stress Urinary Incontinence. More here.

Medical Device News Magazine Interviewed Raul Brizuela, President and CEO of Argentum Medical Regarding the Silverlon® Would Dressing, Applications and Use in the U.S. Military

Originally developed to treat combat injuries, Silverlon is now used throughout the U.S. military. Numerous studies support the advanced antimicrobial dressings’ ability to help healthcare professionals protect patients and improve patient care. More here.

Intelligraphics Inc. Announces IGX MED: Wireless Advanced Roaming Device Driver Suite for Medical Systems

Intelligraphics Inc.

2019-03-20

3/20/19: Mobile Medical systems are being developed with Wi-Fi connectivity to allow portable devices to be easily moved from room to room. Compact mobile devices including infusion pumps, heart and hypertension monitoring, glucose monitoring, and other wearable devices for home healthcare require “always on” Wi-Fi connectivity to stream data and provide alerts to medical staff.

Itamar Medical Launches WatchPAT 300

Itamar Medical Ltd.

2019-03-20

3/20/19: WatchPAT 300 includes several advances that are designed to enhance both patients’ WatchPAT experience as well as provide physicians with a trusted and cost-effective method for rapid, scalable and effective diagnosis of sleep apnea.

Salinas Valley Memorial Healthcare System Establishes Leadership in Cardiac Imaging on the West Coast with Acquisition of Canon Medical Systems’ Vantage Titan / Zen Edition

Canon Medical Systems USA

2019-03-20

3/20/19: The facility, which now has the first MR Theater on the west coast with the acquisition of the Vantage Titan / Zen Edition, is leveraging the technology to perform cardiac exams, as well as vascular, abdominal and neuro imaging exams.

Endologix Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Endologix

2019-03-20

3/20/19: The awards were approved by the Company’s Compensation Committee, which is comprised of independent Directors, on March 13, 2019, as an inducement material to the Awardees’ entry into employment with the Company, as permitted under NASDAQ Listing Rule 5635(c)(4).

Brainlab

Medineering Robotics Platform Company Acquired by Brainlab

2019-03-20

3/20/19: Brainlab creates first openly scalable medical robotics platform paired with an efficient software ecosystem

Oticon Inc.

Oticon’s New Opn S Hearing Aid Delivers More Control and Convenience to Individuals with Hearing Loss

2019-03-20

3/20/19: Pioneering Opn hearing aid now with faster sound processing and a state-of-the-art rechargeable battery

Candela Corporation

Candela and InMode Announce Settlement Of Patent Infringement Lawsuit

2019-03-20

3/20/19: The mutually agreed-upon settlement, through a sublicense from Candela, allows InMode to continue to actively market its bi-polar fractional RF product line, which includes the Fractora and the Morpheus8, protecting Candela's investment in the development of products in the long pulse category. Candela's Profound system is the only FDA-cleared, real-time temperature-controlled device that delivers long pulses of Radio Frequency energy to create all three skin fundamentals – collagen, elastin and hyaluronic acid. InMode's Fractora and Morpheus8 are FDA-cleared for skin ablation and resurfacing, coagulation, hemostasis and treatment of wrinkles.

Allergan plc.

CoolSculpting® and Sonja Morgan Partner to Talk Bikini Denial

2019-03-20

3/20/19: Bikini Denial identifies the feeling that many woman get when realizing that swimsuit season has snuck up on her and she is not prepared to bare it all at the beach or pool until she frees herself of stubborn fat. According to a recent survey, the most common area women feel self-conscious about is their belly1. CoolSculpting is FDA-cleared to reduce fat in the abdomen area, along with eight other areas of the body, and can target that unwanted fat without surgery and little to no downtime.

GTCR

GTCR Announces Partnership with Healthcare Leader Gregory T. Lucier to Form Corza Health

2019-03-20

3/20/19: GTCR, the firm that pioneered The Leaders Strategy™– finding and partnering with management leaders in core domains to identify, acquire and build market-leading companies through transformational acquisitions and organic growth– will invest in Corza Health from GTCR Fund XII, a private equity fund with $5.25 billion of equity capital commitments. Mr. Lucier will serve as Chief Executive Officer of Corza Health and make a substantial investment alongside GTCR.

Aesthetics Biomedical Introduces Vivace 3D Precision – An Optimized, Layered, and Precise Approach to RF Microneedling Treatments

Aesthetics Biomedical Inc.

2019-03-20

3/20/19: A layered treatment technique that further optimizes the clinical outcomes and patient experience that has made the Vivace RF Microneedle one of the fastest growing minimally-invasive skin treatments.

Vixiar Medical

Vixiar Medical Raises $1.5 Million in Additional Financing

2019-03-20

3/20/19: New investors joining in this round included Emerald Development Managers, MMG Opportunities and several individual investors. Existing investors included The Maryland Technology Development Corporation (TEDCO) through its seed fund, the Abell Foundation, individual investors and management.

VisionCare Inc.

VisionCare, Inc. Announces Regulatory Approval of the CentraSight Treatment Program in Australia

2019-03-19

3/19/19: The telescope implant is the only FDA-approved surgical device for advanced macular degeneration and is Medicare eligible. Beyond the United States, it also holds the CE Mark, Health Canada Licence and is approved for use in, Israel, New Zealand and now, Australia. It is manufactured in an FDA registered facility.

AliveCor Inc.

Three New Studies Confirm Clinical Utility of AliveCor’s KardiaMobile Device and AI Algorithms

2019-03-18

3/19/19: "KardiaMobile is the most clinically validated mobile ECG in the world," said Dr. Jacqueline Shreibati, Chief Medical Officer at AliveCor. "Every day, physicians and patients around the globe reaffirm AliveCor's role in improving patient outcomes. AliveCor is proud to be involved in high-quality clinical research, including randomized controlled trials, and prospective validation studies of AI algorithms."

Dyve Biosciences

Positive Results Announced from Pilot Study in Gout Pain at the European Crystal Network Workshop 2019

2019-03-20

3/20/19: Topical, transdermal sodium bicarbonate treatment significantly and safely reduced pain associated with an acute gout flare

Rex Medical L.P.

Patient Enrollment for the REVEAL Peripheral Atherectomy U.S. Trial Completed

2019-03-19

3/19/19: The REVEAL trial is a single arm, prospective study to evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.

Theranica

Theranica Raises $35M to Bring Innovative Migraine Device to the USA

2019-03-18

3/18/19: Nerivio Migra®, the company's novel remote neuromodulation device for acute treatment of migraine, is currently under review of the FDA.

BAXTER

Baxter and bioMérieux Announce Collaboration to Improve Identification and Treatment of Acute Kidney Injury

2019-03-19

3/19/19: The announcement was made at the International Symposium on Intensive Care and Emergency Medicine this week.

Prevencio Inc.

Prevencio Announces Two Validation Studies Confirming High Accuracy of Novel HART AI-driven Tests

2019-03-18

3/18/19: Researchers believe these important findings, presented March 17 at the 2019 American College of Cardiology (ACC) Scientific Sessions in New Orleans, demonstrate the robustness and accuracy of these tests. The new data, from two additional hospitals, confirm results previously published from Massachusetts General Hospital and Dr. James Januzzi.

Neural Analytics Inc.

Neural Analytics, Inc. Announces the First Site Initiation and First Subject Enrollment into the CODEX Study, Utilizing Autonomous Robotic Transcranial Doppler Technology

2019-03-18

3/18/19: “There is a growing interest in the diagnostic potential of measuring the dynamic changes of cerebral blood flow in different neurological conditions. Participating in the CODEX Study using the Lucid Robotic System to offer an autonomous measurement of cerebral blood flow velocities has been exciting. We look forward to advancing the field and expanding the clinical relevance of non-invasive measurement of cerebral blood flow in neurological conditions.” - Dr. Ifeanyi Iwuchukwu, MD, assistant professor of Neurocritical Care and Stroke at The Ochsner Clinical Foundation

Veracyte, Inc.

Veracyte Announces New Afirma Xpression Atlas Data on Medullary Thyroid Cancer

2019-03-18

3/19/19: The findings on this rare, but aggressive form of thyroid cancer will be presented in a guided poster presentation during the conference, which is taking place March 23-26 in New Orleans, La.

Abiomed

Impella RP Post-Approval Study Data Presented at ACC 2019

2019-03-18

3/18/19: The Impella RP is the only percutaneous technology with FDA PMA approval for right heart support designated safe and effective. The table below summarizes the new post-approval study data and compares it to the FDA study results submitted for Impella RP’s PMA approval.

Motus GI® Holdings, Inc.

Motus GI Expands Intellectual Property Portfolio with Issuance of New U.S. Patent for the Pure-Vu® System

2019-03-18

3/19/19: The Pure-Vu® System is a U.S. Food and Drug Administration (“FDA”) cleared medical device indicated to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure.

Theranica

Theranica Raises $35M to Bring Innovative Migraine Device to the USA

2019-03-18

3/18/19: Nerivio Migra®, the company's novel remote neuromodulation device for acute treatment of migraine, is currently under review of the FDA.

Industry’s First Highly Integrated USB-C Buck Charger from Maxim Reduces Size by 30 Percent

Maxim Integrated Products Inc.

2019-03-18

3/19/19: This USB-C buck charger provides the industry's first integrated USB-C port controller and charger to eliminate the need for a separate host controller, simplify software development and reduce overall bill-of-materials (BOM) costs for applications such as financial point-of-sale terminals, power banks, industrial computers, scanners, radios, medical devices, charging cradles, portable speakers and game players.

Market Reports

Global Tuberculosis Diagnostics Market Outlook to 2024 – Nucleic Acid Testing is Expected to Hold the Highest Market Share

Market Analysis 2019-03-19

3/19/19: Factors propelling the growth of the market include the increasing burden of tuberculosis and multidrug-resistant tuberculosis, increasing R&D investments, intensive product pipelines, and increasing government initiatives in the emerging markets.

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China Orthopedic Large Joint Device Market Report Suite 2018

Market Analysis 2019-03-19

3/19/19: Demand for primary hip replacement will remain strong over the forecast period. Following Western trends, the Chinese hip replacement market is slowly shifting towards an increasing acceptance of ceramic implant balls, HCPE liners and cementless hips implants. The market includes knee replacement devices, hip replacement devices and bone cement and will exhibit rapid growth, despite steady price declines caused by both market competition and pressure from the government.

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American College of Cardiology to Launch JACC: Case Reports

Market Analysis 2019-02-25

2/25/19: JACC: Case Reports will be launched September 2019 and Julia Grapsa, MD, PhD, will serve as the editor-in-chief.

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Non Profit News

Patients with Irreparable Rotator Cuff Tears May Have Another Surgical Option

NON PROFIT 2019-03-18

3/18/19: The study, which examined patient outcomes up to five years after surgery, built upon earlier research which examined short-term patient results

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Advancing Clinical Trials for Leukemia Patients is Helping Improve Survival Rate

NON PROFIT 2019-03-14

3/14/19: The society says that: "Taking part in a clinical trial may be the best treatment choice for some acute myeloid leukemia (AML) patients. Clinical trials are under way for patients at every treatment stage and for patients in remission. Virtually all of today's standard treatments for cancer are based on previous clinical trials."

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Interdisciplinary Education Helps Hospital Patients Better Understand Their Medications

NON PROFIT 2019-03-13

3/11/19: Patient satisfaction scores for medication understanding increased, while readmission rates decreased following program implementation

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Executives

Mitchell Levinson Appointed to Pulse Biosciences Board of Directors

Executives

2019-03-19

3/19/19: Levinson, 58, has more than 25 years of experience bringing novel medical technologies to the market, including over a decade in the aesthetics procedure market.

Sandra Clarke, CPA, CMA Appointed CFO of Synaptive Medical

Executives

2019-03-19

3/19/19: Ms. Clarke joins Synaptive Medical with decades of experience in financial management and operations, having led a variety of small-to-mid-sized companies.

Robert Richard, Ph.D. Appointed Vice President of Research and Development at Anika Therapeutics

Executives

2019-03-18

3/19/19: Dr. Richard is a 20-year research and development (R&D) veteran bringing extensive leadership and product development experience in orthopedic and regenerative medicine.

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