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.

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.

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.
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.
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.
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.
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.”
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.”
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.
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.
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.
2/12/19: Raymond W. Cohen, CEO of Axonics, commented, “Without this Full Body labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator and lead surgically explanted prior to the MRI scan, resulting in loss of an effective treatment, another surgery for the patient and additional cost to the patient and healthcare system. Our robust testing and analyses conclude that Full Body MRI scans can be safely performed on patients with an implanted Axonics r-SNM system.”
2/11/19: Sheaumann Laser specializes in the design and manufacture of semiconductor lasers and modules for industrial, defense, medical, and printing applications.
2/12/19: The launch of the cryoSPHERE probe demonstrates AtriCure’s commitment to continued innovation in Cryo Nerve Block Therapy.
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.”
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.
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.
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."
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.

M6-C Artificial Cervical Disc Receives FDA Approval

2/7/19: M6-C artificial cervical disc is the only artificial cervical disc that mimics the anatomic structure of a natural disc. Designed to restore physiologic motion to the spine, the M6-C disc is indicated as an alternative to cervical fusion. The disc preserves motion by restoring biomechanical function at the treated level after native disc removal and potentially reduces subsequent degeneration of adjacent vertebral segments.
2/7/19: Acquisition creates first company to offer product line for minimally invasive orthopedic diagnostics and surgical solutions.

Lunaphore Technologies SA Launches Its First Product LabSat(TM)

2/7/19: LabSatTM is the first solution in Lunaphore’s pipeline to reach the market since the foundation of the company. The system consists of a single-slide, automated reagent delivery system performing immunohistochemistry tests on tissue samples within 10 to 30 minutes.
2/7/19: Previously indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments, the new indication opens options for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.
2/7/19: The research shows that while most people are optimistic about new health innovations, anxieties and fear may prevent people from seeking effective treatment for their heart health.
2/6/19: The High-Performance Nitinol Tubing Center of Excellence is ideally set up to support medical device companies that require world-class Nitinol tubing for their designs for long-term implantable applications within the heart and other critical structures.
2/5/19: Venus Heal™ is powered by RP3 technology, which synergistically combines the benefits of Multi-Polar Radio Frequency, Pulsed Electro Magnetic Fields, and massage.
2/6/19: The TIMELESS trial is designed to evaluate whether tenecteplase is safe and effective for use in AIS when administered between 4.5 and 24 hours after stroke onset.
2/5/19: The TIF 2.0 procedure is a minimally invasive endoscopic intervention performed with the EsophyX® device that enables anatomic correction of the gastroesophageal valve without the resulting complications associated with traditional fundoplication. The retrospective data are reported in a paper titled “pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication,” and appear in the January - March 2019 issue of the Journal of the Society of Laparoendoscopic Surgeons.
2/6/19: FIVAD is based on technology created by Leviticus Cardio, a medical technology company headquartered in Israel. It uses patented Coplanar Energy Transfer to wirelessly power a heart pump, a Ventricular Assist Device. FIVAD incorporates a heart pump produced by Jarvik Heart Inc.
2/5/19: Dr. Kugler will be one of a select group of clinical investigators across the United States for the IC-8 lens study.
2/6/19: The agreement with Surface Generation is directly in line with Victrex's strategy of continued investment in its mega-programs, parts portfolio offering new and innovative disruptive technologies that not only extend the company's capabilities as a material solutions' provider, but also complement Victrex’s wider technology offering to its customers. Victrex has invested a small equity stake in Surface Generation, alongside the ability to utilize the technology.
2/4/19: ASA President Linda Mason, M.D., FASA said, "We're excited to be working with Digital Surgery to fill a need in the medical community. Delivering high caliber education in a format that is easily accessible to all members of the anesthesia care team is crucial, and one that will have a great effect on patient safety and contribute to more successful outcomes."
2/4/19: Both key scientific studies validate its product's ability to improve the repair of two distinct joint tissues, the rotator cuff tendon and articular cartilage.
2/4/19: Information gained through the MOMENTUM study will guide the use of MR/RT to improve outcomes for cancer patients.
2/4/19: John Sun of Light Bridge Ventures stated, “uLab Systems software is quite impressive and allows dental practitioners to create an aligner plan in as little as 10 minutes. We believe uLab Systems is the missing piece that will bring aligner treatment and printing in-house for many orthodontists.”

Global Kinetics Corporation Announces Publication of a Joint Study in the Journal of Parkinson’s Disease

2/4/19: Study authors concluded that the Personal KinetiGraph®, a wearable device that precisely monitors, quantifies, and reports movement symptoms in patients with Parkinson’s disease, provided additional information beyond that which is typically captured during routine clinical visits. The company reports the new data is significant enough to change the medical management of nearly one-third of the participating patients.

Boston Scientific Launches Spectra WaveWriter™ Spinal Cord Stimulator System in Europe

1/31/19: Spectra WaveWriter™ Spinal Cord Stimulator allows physicians & patients to specifically target one area of pain, or multiple areas, with one or both types of therapy to address individual needs.

Medigate Closes $15M Series A Funding To Meet Demand for Specialized Medical Device Security and Asset Management

1/29/19: Medigate reports the $15M Series A financing was led by new investor U.S. Venture Partners (USVP) with participation by current investors YL Ventures and Blumberg Capital.

Medtech Company Perfuze Raises €3 Million in Seed Round

1/29/19: “Perfuze has a technology with the potential to significantly improve outcomes for stroke patients,” says John Yianni, Partner at Earlybird. “We are delighted to offer our financial and commercial support in helping this exciting company grow and get its life-saving technology to market.”

Asuragen NGS System for Streamlined Detection of RNA Lung Cancer Variants Demonstrates Superior Performance in Multisite Evaluation

1/29/19: The peer-reviewed article, titled “Design, Optimization, and Multisite Evaluation of a Targeted Next-Generation Sequencing Assay System for Chimeric RNAs from Gene Fusions and Exon-Skipping Events in Non–Small Cell Lung Cancer,” also describes the design and development of the assay system. This system includes controls, pre-analytical sample QC, targeted RNA-based enrichment, library clean-up and pooling, and companion bioinformatics software that analyzes the corresponding next-generation sequencing (NGS) data.

C2N Diagnostics Receives Breakthrough Device Designation from U.S. FDA for Blood Test to Screen for Alzheimer’s Disease Risk

1/29/19: This test will be used to screen for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis. To qualify for the FDA’s Breakthrough Device Program, a medical device must provide more effective diagnosis or treatment of a life-threatening or irreversibly debilitating condition, among other criteria. This program is designed to expedite the development and review of such medical devices.

Abcam Expands Custom Services Capabilities with the Acquisition of Calico Biolabs

1/28/19: Calico Biolabs partners with many of the leaders in the diagnostics and biopharmaceutical industries to create custom products for companion diagnostics.

Horizon Discovery and Rutgers University Form Exclusive Partnership to Develop Next Generation Novel Gene Editing Technology

1/28/19: As part of the agreement, Horizon has made a non-material payment to Rutgers for an option to exclusively license the base editing technology for use in all therapeutic applications.

Market Reports

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

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

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

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

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

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

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

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

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.
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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