Medical Device News Magazine

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

Cook Medical Receives U.S. FDA Approval for Aortic Dissection Device

2019-02-04

The Zenith Dissection Endovascular System consists of a proximal stent-graft component and a distal bare stent component, provides physicians a less invasive alternative to open surgery for repair of Type B dissections of the descending thoracic aorta. The device will be available for sale in the U.S. in the coming months.

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.

Publication of Outcomes of Endoscopic Sleeve Gastroplasty (ESG) in 1,000 Consecutive Patients

Apollo Endosurgery

2019-02-19

2/19/19: ESG is an endoscopic minimally invasive weight loss procedure based on full-thickness endoscopic suturing using Apollo’s OverStitch™ device. In the ESG procedure, a series of sutures are placed through the gastric wall reducing the stomach volume by 80% creating a restrictive endoscopic sleeve. The result allows a patient to consume less food and remain satiated longer.

First Patient Successfully Treated in Pain Prevention Study Prior and Post-Surgical Debridement of Venous Leg Ulcers

Medical Ethics Pty Ltd

2019-02-19

2/19/19: Professor Keith Harding, Principal Investigator, Welsh Wound Innovation Centre, commented: “We are pleased to initiate this important study looking at mitigating pain for patients with venous leg ulcers. The first patient was successfully treated, allowing the wound to be fully debrided without any reported sensation or pain. Pain associated with venous leg ulcers is a significant unmet need and I am excited by the potential of Medi-Solfen® in providing a convenient, safe and effective method of pain mitigation in such wounds. I look forward to delivering the full data following completion of the clinical trial.”

ARTISAN-SNM Pivotal Study Shows Positive Top-Line Clinical Data

Axonics Modulation Technologies Inc.

2019-02-19

2/19/19: The clinical study demonstrated that patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in Urinary Urgency Incontinence (“UUI”) symptoms and quality of life. Additionally, the study met all secondary endpoints. No serious device-related adverse events have been reported.

Medtronic Receives FDA Breakthrough Designation for Developing Personalized Closed Loop Insulin Pump System for Diabetes Management

2019-02-19

2/19/19: "We are very excited to receive the Breakthrough Device designation from the FDA as it will help us deliver this broadly anticipated innovation to patients much sooner than expected," said Alejandro Galindo, president of the Advanced Insulin Management division within the Diabetes Group at Medtronic. "We believe the Personalized Closed Loop system will be transformational for diabetes management, and the personalized nature of the algorithm clears the path to a true closed loop system. We have a long history of partnership with the FDA and look forward to another successful collaboration with the Agency to bring this important innovation to patients."

Publication of Pure-Vu® System Clinical Study Data in Peer-Reviewed Journal of Clinical Gastroenterology

Motus GI® Holdings, Inc.

2019-02-19

2/19/19: Pure-Vu® System is a U.S. FDA cleared medical device indicated to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure. The device integrates with standard and slim colonoscopes to enable safe and rapid cleansing during the procedure while preserving established procedural workflow and techniques.

Critical Manufacturing Announces Significant Growth in Revenue and MES Orders

Critical Manufacturing

2019-02-19

2/19/19: Francisco Almada Lobo, CEO at Critical Manufacturing said, “The manufacturing landscape is undergoing significant changes and our MES is an essential element of our customers smart manufacturing strategy.

Corindus Announces FDA Submission for Neurovascular Intervention Indication for CorPath® GRX Vascular Robotic System

Corindus Vascular Robotics, Inc.

2019-02-14

2/14/19: An expansion of CorPath GRX Vascular Robotic System to treat neurovascular conditions would represent a major stepping stone towards our goal of revolutionizing stroke treatment,” said Mark Toland, President and Chief Executive Officer of Corindus.

Allcure Kangtai Selects Mevion Compact Proton Therapy System to Equip Hospital in Southwest China

Mevion Medical Systems®

2019-02-13

2/19/19: Mevion notes they are the first company to innovate this new approach to proton therapy and continues to transform the industry and patient care with HYPERSCAN Pencil Beam Scanning.

The Flower Jones Screw and the 6.5mm Headless Compression Screw: Two New Additions Added to Flower Orthopedics Ready-for-Surgery™ Product Line

Flower Orthopedics

2019-02-13

2/13/19: These two screw systems allow me to treat a greater variety of surgical problems with sterile, Ready-for-Surgery implants and instruments, increasing efficiency and minimizing infection potential.

Vapotherm® Releases Next Generation of Capital Unit: Precision Flow Hi-VNI™ System

2019-02-13

2/13/19: The new generation of the Precision Flow® Hi-VNI™ system, both the hardware and software have been updated to improve reliability, and to comply with the EMC 4th Edition requirements for medical devices, IEC 60601-1-2:2014.

Zebra Medical Vision Receives Grants from the Israel Innovation Authority to Deploy Medical Imaging AI at Scale

Zebra Medical Vision

2019-02-14

2/14/19: Zebra Medical will put its AI algorithms to use in critical emergency situations at Ichilov Hospital, and will work to detect early signs of breast cancer and osteoporosis at Macabi and Clalit HMOs.

Johnson & Johnson Announces Agreement to Acquire Auris Health, Inc.

Johnson & Johnson

2019-02-13

2/13/19: Johnson & Johnson entered into a definitive agreement to acquire Auris Health, Inc. for approximately $3.4 billion in cash. Auris Health is a privately held developer of robotic technologies, initially focused in lung cancer, with an FDA-cleared platform currently used in bronchoscopic diagnostic and therapeutic procedures. This acquisition will accelerate Johnson & Johnson's entry into robotics with potential for growth and expansion into other interventional applications.

Dr. Raymond Gardocki of the Campbell Clinic in Memphis, TN, Performs His 100th Endoscopic Spine Surgery Utilizing joimax® Technologies

2019-02-13

2/13/19: Dr. Raymond Gardocki said, “We are very excited to have completed our 100th endoscopic spine surgery. Seeing the rapid recovery and decrease in morbidity with the endoscopic approach makes me wonder why everybody doesn’t do spine surgery this way.”

University of Minnesota First in U.S. to Offer New Targeted Therapy for Recurrent Brain Tumors

GT Medical Technologies Inc.

2019-02-14

2/14/19: “At University of Minnesota Health, our mission is to advance new, safe, and effective therapeutic options for the many brain tumor patients who did not respond to the standard-of-care therapies,” Chen said. “Moreover, the University of Minnesota Medical School’s Department of Neurosurgery has a long-standing history of contribution in radio-biologics. To be the first institution in the U.S. to offer the GammaTile Therapy is particularly satisfying in this context.”

U.S. Renal Care to Be Acquired by Investor Group

U.S. Renal Care Inc.

2019-02-13

2/13/19: U.S. Renal Care partners with nephrologists and hospitals to develop, acquire, and operate outpatient treatment centers for patients suffering from kidney failure, also known as end stage renal disease.

Echosens’ FibroScan® Selected by NASHNET Centers of Excellence Network

2019-02-13

2/13/19: Dr. Dieterich points to FibroScan as a rapid, noninvasive quantification tool at the point of care that may enable efficient and cost-effective early screening and subsequent disease identification.

ReWalk Announces Cigna as First Private U.S. Insurer to Adopt National Policy Change for Coverage of Personal Exoskeleton Devices

ReWalk Robotics Ltd

2019-02-13

2/13/19: Cigna, which previously had a non-coverage policy, will now review submissions from beneficiaries on a case-by-case basis to consider providing coverage based on medical criteria.

ARTISAN-SNM Pivotal Study Shows Positive Top-Line Clinical Data

Axonics Modulation Technologies Inc.

2019-02-19

2/19/19: The clinical study demonstrated that patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in Urinary Urgency Incontinence (“UUI”) symptoms and quality of life. Additionally, the study met all secondary endpoints. No serious device-related adverse events have been reported.

Sheaumann Laser Receives $2.3M Massachusetts Manufacturing Innovation Initiative Award

Sheaumann Laser, Inc.

2019-02-11

2/11/19: Sheaumann Laser specializes in the design and manufacture of semiconductor lasers and modules for industrial, defense, medical, and printing applications.

cryoICE® cryoSPHERE™ Probe Launched by AtriCure

2019-02-12

2/12/19: The launch of the cryoSPHERE probe demonstrates AtriCure’s commitment to continued innovation in Cryo Nerve Block Therapy.

Baxter and NantHealth® Advance Digital Health Technology for Medical Devices in the Hospital ICU

2019-02-11

2/11/19: “The ICU requires coordinated care among specialists and nurses, further complicated by the need to manage data streams from numerous medical devices,” said Brian Tufts, Baxter’s lead for Acute Therapies in the U.S. “When customers use technology to streamline connectivity of Prismaflex to their IT systems, busy nurses are no longer tasked with manually charting treatment data. We are excited about this development as we work to create digital health solutions to help our customers turn data into meaningful insights to improve patient care.”

Edwards Lifesciences Enters Into Agreement To Acquire CASMED

Edwards Lifesciences Corporation

2019-02-12

2/19/19: Edwards will acquire CASMED in an all-cash transaction for $2.45 per share of Common Stock, or an equity value of approximately $100 million.

Spok Introduces a New Cloud-Native Clinical Communication Platform Powered by Amazon Web Services

2019-02-11

2/11/19: The first-of-its-kind cloud-native enterprise communication platform includes a fully integrated healthcare contact center, clinical alerting and alarm management solution, and a multi-device application for care team messaging. Spok Care Connect makes care collaboration easier by connecting important care team and patient information into messaging and alerting applications.

Invotec Opens a Facility in Villingen-Schwenningen Germany

Invotec Engineering Inc.

2019-02-12

2/12/19: "Southern Germany is a long-standing hub for medical technology as well as automation across Europe," says Armin Doser, CEO of Invotec GmbH. "With our experience in medical device manufacturing, we want to show our commitment to growing and serving this region as well as our existing international customers."

PicoLO™ Picosecond Nd:YAG Laser Receives FDA 510(k) Clearance for Use in Dermatology, General and Plastic Surgery

LASEROPTEK Co Ltd.

2019-02-12

2/12/19: PicoLO™ Picosecond Nd:YAG Laser generates high peak power and consistent picosecond pulse duration producing the strongest photomechanical forces within the skin to quickly and effectively breakdown and fragment pigments such as those found in tattoos.

Market Reports

Transcatheter Treatment 2019 Players Include Abbott Labs, Boston Scientific, Medtronic, Vascular Innovations and Valcare

Market Analysis 2019-02-12

2/12/19: Regionally, the U.S. is expected to maintain dominance in the global market of transcatheter treatment devices. Those wishing to invest in the transcatheter treatment devices market ought to strongly consider high-growth areas such as transcatheter aortic valve repair (TAVR), transcatheter mitral valve implantation (TMVI), and transcatheter mitral valve repair (TMVR) devices and technologies.

Endometrial Ablation Devices Market Outlook for 2019-2023

Market Analysis 2019-02-07

2/7/19: The endometrial ablation devices market will register a CAGR of nearly 6% by 2023.

Demand for Neurovascular Thrombectomy Devices to Surge on Account of Growing Incidences of Acute Ischemic Stroke

Market Analysis 2019-01-17

1/17/19: The key players operating in the neurovascular thrombectomy devices market are focused on acquiring companies in order to expand their product offerings and gain maximum share in the terms of revenue in the global neurovascular thrombectomy devices market

Non Profit News

Use of Clinical Apps Significantly Improves Quality of Cardiovascular Care

NON PROFIT 2019-02-14

2/14/19: Patients experienced improvement in angina symptoms, quality of life.

Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths

NON PROFIT 2019-02-14

2/14/19: The Heart Care Navigation Team was established in 2017 with the goal of reducing unnecessary readmissions, improving mortality and improving patients’ experience. Patients in the program are assigned a health advocate and a nurse navigator who meet the patients while they are in the hospital. The team helps with timely access to follow-up care, promotes self-management and addresses patients’ questions or concerns for a period of 90 days after discharge.

American College of Cardiology Acquires MedAxiom

NON PROFIT 2019-02-04

2/4/19: Through this acquisition, the ACC will expand its offerings as the professional home for the entire cardiovascular team to include services and education in non-clinical domains such as interpersonal and organizational leadership, strategic design, operational and performance management, and improvement and technological infrastructure.

Executives

Nortech Systems Names Jay D. Miller President and CEO

2019-02-19

2/19/19: We are pleased that Jay will guide Nortech Systems into the future because he brings the vision, leadership and experience necessary for us to achieve our next chapter of growth,” said David Kunin, chairman of Nortech’s board of directors. “Our national executive search process was widespread and rigorous, as we evaluated numerous qualified candidates,” added Kunin.

Natus Medical Announces Continued Board Refreshment with Two New Independent Directors

2019-02-13

2/13/19: “We are pleased to welcome Alice and Tom as new independent directors to the Natus Medical board,” said Barbara R. Paul, M.D., Chairperson of Natus' board of directors.

Georgia Bio Names Maria Thacker-Goethe President and CEO

2019-02-08

2/8/19: Maria Thacker-Goethe has served in a variety of roles for Georgia Bio over the years including Marketing, Membership and Project Manager.

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