Monday, June 24, 2019
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Breaking Medical Device Industry News

Medical Device Industry News

Welcome! Medical Device News Magazine brings you the latest medical device industry news, clinical trials and 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! Learn more.

Monday, June 24, 2019

FDA IDE Approval for Pivotal Clinical Trial of MicroStent

Micro Medical Solutions
IDE approval allows the company to initiate a U.S. pivotal clinical trial to evaluate MicroStent’s safety and efficacy. MicroStent has already obtained CE Mark approval for use in the EU. MicroStent is a vascular stent specifically designed to achieve and maintain vessel patency and improve blood flow in order to reduce below-the-knee amputations for patients with critical limb ischemia (CLI) resulting from peripheral artery disease (PAD). Last fall, MMS completed a 3-center, 15-patient feasibility study of MicroStent in which MicroStent met all primary endpoints for both safety and efficacy.
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Statement from Medtronic Regarding FDA Circulatory System Devices Panel

Medtronic
The panel presentations and deliberations addressed a wide range of considerations related to paclitaxel drug-coated balloons (DCB) and drug-eluting stents (DES). Laura Mauri, M.D., vice president, Global Clinical Research & Analytics, Medtronic also presented alongside Dan Clair, M.D., chair of the Department of Surgery for the University of South Carolina (USC) and the Palmetto Health-USC Medical Group and Eric A. Secemsky, M.D., MSc, RPVI, FACC, FVSM, Beth Israel Deaconess Medical Center, Harvard Medical as part of an unprecedented pan-industry presentation.
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Acutus Medical Announces $170 Million Financing

Acutus Medical
The company provides next-generation electrophysiology technology solutions that can enable personalized and adaptive approaches to therapy. 
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Omron Healthcare Expands Capabilities for Connected Blood Pressure Monitor Users

Omron Healthcare Inc.
"These updates to our exclusive Omron Health skill for Amazon Alexa are another step forward in growing adoption of regular blood pressure monitoring and shaping positive behavior change. Those objectives are central to our mission of Going for Zero heart attacks and strokes. By making it easier and more convenient to track blood pressure trends over time, we can help empower users to understand their condition and take action to reduce their health risks," said Ranndy Kellogg, president and CEO of Omron Healthcare.
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Publication of Study Validating Use of MammaPrint and BluePrint Molecular Diagnostics using Targeted RNA Next-Generation Sequencing Technology

Agendia Inc
MammaPrint and BluePrint Molecular Diagnostics using targeted RNA Next-Generation Sequencing technology has been published in the Journal of Molecular Diagnostics.
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Alliance Between VEITHsymposium and Transcatheter Cardiovascular Therapeutics

VEITHsymposium
As part of this alliance, the two organizations will closely collaborate on creating educational content for physicians, surgeons and other healthcare professionals. The VEITHsymposium leadership will be actively involved in developing the endovascular program for TCT 2019, taking place September 25-29 in San Francisco, California. The VEITHsymposium group will also plan dedicated critical limb ischemia and aortic sessions at TCT 2019. Similarly, CRF will actively participate in the development of a two-day hands-on training pavilion and other interventional sessions at this year’s VEITHsymposium, which will take place November 19-23 in New York City.
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Publication of Study Validating Use of MammaPrint and BluePrint Molecular Diagnostics using Targeted RNA Next-Generation Sequencing Technology

Agendia Inc
MammaPrint and BluePrint Molecular Diagnostics using targeted RNA Next-Generation Sequencing technology has been published in the Journal of Molecular Diagnostics.
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PureTech Health Establishes New Corporate Headquarters in Boston’s Seaport District to Support Expansion and Acceleration of Internal R&D Pipe

PureTech Health
“The PureTech team has initiated and advanced highly differentiated product candidates initially targeting serious disorders of the brain, immune system, and gastrointestinal tract, and has progressed more than two dozen product candidates from discovery through various points of validation, including one all the way through FDA regulatory clearance. It is through this track record of execution that we have built our leadership position around brain-immune-gut “BIG” axis biology and identified the platforms that form the basis of our internal R&D pipeline programs,” said founder and CEO Daphne Zohar.
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DIXi Group Parnters with Aleva Neurotherapeutics

Aleva Neurotherapeutics
DIXI Medical SAS in Besançon is the world leader in the manufacture of intracerebral electrodes for SEEG. The current conventional mode of production limits the company's ability to meet the demand of a rapidly growing market and prohibits the necessary evolution in therapeutic modalities that only the nanotech dimension can facilitate.
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Clinical Study Aims to Show DABRA Excimer Laser System Keeps Arteries Healthy Longer

Ra Medical Systems
“Restenosis, or re-narrowing of an artery post-procedure, is a major problem for my patients,” said C.V. Ramana, MD, principal study investigator. “In my experience, DABRA has provided a highly effective treatment, with minimal vascular trauma, which I believe leads to lower rates of restenosis and longer lasting results,” Dr. Ramana practices at NAADI Healthcare in Oklahoma City, OK.
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VISTASEAL Open and Laparoscopic Dual Applicator Devices Designed to Deliver Biologics that Addresses Surgical Bleeding

Johnson & Johnson
Ethicon has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VISTASEAL open and laparoscopic Dual Applicators (35 cm and 45 cm), three next generation airless spray devices that combine biologics with device technology to address mild to moderate surgical bleeding.  
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Deep Convolutional Neural Network Image Reconstruction Technology for CT Receives FDA Clearance

Canon Medical Systems USA
“Our AiCE technology utilizes a next generation approach to CT image reconstruction, further proving Canon Medical’s leadership and commitment to innovation in diagnostic imaging,” said Dominic Smith, senior director, CT, PET/CT, and MR Business Units, Canon Medical Systems USA.
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CardioFocus Launches 100th HeartLight® Center Worldwide

CardioFocus Inc.
"We've seen a surge in demand for the HeartLight System and have more than doubled the number of hospitals offering the technology over the last twelve months," said Omari V. Bouknight, President and Chief Commercial Officer at CardioFocus. "AFib is a widespread, debilitating condition that requires advanced solutions to improve outcomes. By collaborating with leading institutions and physicians in the field, we will make this revolutionary treatment available to a greater number of patients worldwide."
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Foster Corporation Breaks Ground on New Plant Expansion

Foster Corporation
According to Larry Acquarulo, Foster Corporation CEO and owner, “Foster’s recent growth has necessitated the new building as both our compounding and distribution businesses have grown to the point that space would become a limiting factor for Foster if we didn’t make this move.
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Ovation Fertility Announces New Private Equity Investor: Morgan Stanley Capital Partners

Ovation Fertility
“I am delighted to announce that after extensive exploration and negotiation, Ovation Fertility has accomplished its goal of recapitalization in partnership with one of private equity’s most respected names,” said Nate Snyder, Ovation’s chief executive officer.
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Denton Vacuum Sells First Discovery 200 Sputter System to Medical Implant Manufacturer

Denton Vacuum
David Douglass, Senior Product Manager at Denton Vacuum, stated that "We're thrilled to see that the Discovery 200 solves our customer's challenges, both for their high-volume production process and their unique thin film specifications.
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Diaceutics PLC Invests Additional £1 Million in Patient Data to Improve Outcomes

Diaceutics PLC is a diagnostics data analytics and implementation services company. Utilizing Diaceutics’ proprietary software, this anonymized patient data is being acquired through new partnerships with a number of key commercial reference laboratories, academic institutions, payers and data providers from the US, Asia, UK and Europe.
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New View Surgical Closes Series A Round of Financing

New View Surgical Inc.
New View Surgical’s initial device, the VisionPort™ System, is a novel surgical imaging and access system for minimally invasive surgery that aims to simplify laparoscopic procedures across all specialties by reducing the need for a separate camera port and camera holder and allowing multiple simultaneous views of the operative field.
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MEDICREA® Group Secures New Patents to Protect its Proprietary Platform Technology UNiD ASI

The Medicrea Group
Over the last few years, MEDICREA® Group has had a leading role in revolutionizing the personalized spine surgery. Its disruptive ideas and innovative patient specific technologies have been instrumental in shaping the future spine industry business model associating precise analysis of each patient and pre-op planning expert services to the implants.
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NuVasive Announces Commercial Launch of Modulus® TLIF-O

NuVasive Inc.
Modulus® TLIF-O features porous surface technology that, based on pre-clinical data, provides a favorable environment for bone in-growth and bone on-growth, and consistently achieves stronger osseointegration than solid implants with smooth or rough surfaces.
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New Cochlear™ Nucleus Sound Processor® Profile™ Plus Series Cochlear Implant and Nucleus 7 Sound Processor Receive FDA Approval

Cochlear Limited
Cochlear reports the Nucleus Profile Plus Implant is designed for safe access to Magnetic Resonance Imaging (MRI) scans today and in the future.
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Soliton Announces $9.45 Million Private Placement

Soliton Inc.
Soliton will sell an aggregate of 675,000 shares of the Company's common stock at $14.00 per share. Each share will be sold together with a warrant to purchase 0.7 shares of common stock.
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ROADSTER-2 Demonstrates Compelling Patient Outcomes with Strong Safety Profile

Silk Road Medical Inc.
Final Results Presented during the late-breaking session at the Society for Vascular Surgery Annual Meeting
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Mimics Enlight Cardiovascular Planning Software Suite Receives FDA Clearance

Materialise
Created in collaboration with Henry Ford Health System in Detroit with Dr. Dee Dee Wang, MD, FACC, Director of Structural Heart Imaging, and leveraging the Henry Ford Innovation Institute’s patented workflow, Mimics Enlight is intended to support patient selection and planning for structural heart and vascular therapy.
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Terumo Enhances Coronary Interventional Product Portfolio By Securing Exclusive Global Rights to Orchestra BioMed’s Virtue® Sirolimus-Eluting Balloon (SEB) through Global Strategic Partnership

Terumo Corporation
Under the terms of the agreement, Terumo will make a one-time, up-front payment of USD 30 million and an equity commitment of USD 5 million to Orchestra BioMed. Terumo will also make substantial future clinical and regulatory milestone payments to Orchestra BioMed.
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First Smartphone-based Digital Platform to Assist Autism Therapists Announced

Alternative Behavior Strategies
This is the first smartphone-based platform to connect autism behavioral therapists to the information and knowledge they need—wherever they are—to enhance services and promote clinical excellence and advancement.
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Circassia Pharmaceuticals Receives Innovative Technology Supplier of the Year Award from Vizient

Circassia Pharmaceuticals
“We are pleased to recognize Circassia as our supplier of the year for Innovative Technology. This award reflects their commitment to collaboration and service excellence that helps Vizient’s members meet their goals for supply chain efficiency and cost management,” said Jody Hatcher, president, supply chain services for Vizient.
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Blossom Innovations Advances Its Latest Medical Technology Platform for Dermatology

Blossom Innovations LLC
“As innovators, it is exceptionally rewarding when one of our technologies progresses towards global commercialization,” said Irina Erenburg, Ph.D., co-founder, president, & CEO of Blossom Innovations. “We are thrilled to have R2 Dermatology work with Huadong Medicine to help us enter the largest market for skin lightening medical devices.”
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BIOCORP Announces The CE IIb Approval of Its Mallya Device

BIOCORP
Mallya device is a smart sensor that turns conventional insulin pens into connected devices. Mallya records the key treatment information (selected dose, date and time of injection) and sends it to a dedicated mobile application.
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Applied BioCode Obtains FDA Clearance of the Roche MagNA Pure 96 Extraction System for its Gastrointestinal Pathogen Panel

Applied BioCode
Now, with the addition of the MagNA Pure 96 System, Applied BioCode will have access to higher volume laboratories that utilize the Roche system for sample extraction.
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The Lightest See-Through Head-up Display Solution for Glasses

ActiveLook
ActiveLook is the first technological ingredient that transforms sports glasses into perfect visors. Lightweight, compact and based on Bluethooth® technology, it can be easily integrated into a pair of regular sports glasses instantly displaying information and performance.
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ClinOne and Virtual Clinical Trials: A Natural Fit

ClinOne states their platform includes managing all of these critical elements, allowing patients to manage the majority of their trial experience from the comfort of their own homes.
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Sharesource 2.0 Telehealth Platform Launch by Baxter

“While the global patient population requiring dialysis is growing, the number of clinicians and their resources are not increasing,” says Laura Angelini, general manager, of Baxter Renal Care business.
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AED Leader Cardiac Science Agrees to Be Acquired by ZOLL

As part of the agreement, ZOLL will acquire Cardiac Science’s product portfolio and pipeline, along with its facilities in the United States and Europe. Additional terms of the agreement are not being disclosed. The acquisition is subject to anti-trust regulatory approval and other customary closing conditions. Until closing, the companies will operate independently.
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SAGA Diagnostics Raises 40 Million SEK (€3.7 Million)

Hadean Ventures, a Nordic focused European life science fund manager, leads the round, and is joined by a number of existing shareholders including Fårö Capital and the Gunnar Nilsson Cancer Foundation. 
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Varian to Demonstrate New Bravos Afterloader System at ABS 2019

The Bravos afterloader is an integrated system designed to improve the patient and clinic experience by simplifying brachytherapy treatments and providing greater workflow efficiency.
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New Analysis Shows Sleep Apnea More Common in Americas than Previously Thought

ResMed
“Previous estimates stated 100 million worldwide have sleep apnea. Now we know it’s nearly double that in just the Americas alone,” said study coauthor and ResMed Chief Medical Officer Carlos M. Nunez, M.D.
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Innovia Medical Announces Acquisition of MD Resource Corp

Innovia Medical Company
“Since their founding in 1985, MD Resource has established themselves as a respected manufacturer and global supplier in the lipoplasty and cosmetic space, and has achieved much success through their quality and trusted customer relations,” said Terry Meredith, Chief Executive Officer of Innovia Medical.
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Market Pure-Vu® GEN2 Receives FDA Clearance

The company reived 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the second-generation Pure-Vu® System (“Pure-Vu® GEN2”) to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure.
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PrinterPrezz Establishes Co-Location Center to Accelerate Additive Manufacturing of Medical Devices

PrinterPrezz, Inc. has partnered with UCSF Surgical Innovations, an incubator-accelerator for medtech innovators at UC San Francisco. Together, both groups are focused on bringing advanced medical devices to market faster.
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Final Clinical Results from Pilot Study Showing Closure of Diabetic Foot Ulcers Using SkinTE™

PolarityTE Inc.
The results of the study included the healing of all harvest sites and complete SkinTE graft take one week after SkinTE™ application
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Portable, Reliable Saliva-Based Hydration Testing System Emerges

MX3 Diagnostics
The saliva-based hydration system uses a handheld digital meter and app to measure and track personal hydration levels. It is the world’s first point-of-care system using saliva to provide immediate and accurate diagnostic tests for health and fitness.
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New Thermo Scientific Scientific HAAKE MARS iQ Rheometer Series Is Designed for Quality Control Labs

Thermo Fisher Scientific
Key features such as touchscreen control that allows users to quickly execute standard operating procedures (SOPs) and intuitive "Connect Assist" functionalities mean QC lab technicians can deliver more consistent and reliable results, even in busy labs with multiple operators running tests.
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MUSA Microsurgery Robot Receives CE-Mark

Microsure
MUSA Microsurgery Robot was developed by a team of microsurgeons and engineers, creating a high-precision robotic assistant that is compatible with current operating techniques, workflow, instruments, and other OR-equipment.
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TruDiagnosiss® Multiplex Diagnostic System Receives FDA 510(k) Clearance

Akonni Biosystems Inc.
With this approval, Akonni is poised to enter the $8B molecular diagnostics market. The TruDiagnosis® Multiplex Diagnostic System is a compact point of service molecular diagnostic device which includes the TruDx® 2000 Imager & the TruArray® consumable test kit, both unique & patented technologies developed at Akonni.
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Mark Cuban & Top Pulmonary Doctors Discuss Healthcare Technology Opportunity Issues

EON
"Stop siloing data," said Cuban. "My perception of it [referring to doctors using electronic medical records] is that you try to fit whatever you can into the square and round holes that are alreay there, and that's not necessarily optimized for process."
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WatchPAT™ One, the First and Only Fully Disposable Home Sleep Apnea Test Receives FDA 510(k) Clearance

Itamar Medical Ltd.
WatchPAT™ One technology and the first and only fully disposable Home Sleep Apnea Test (HSAT). WatchPAT One incorporates the technology and comfort advances of WatchPAT 300, which received 510(k) clearance in August 2018 and was launched in March 2019.
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Hintermann Series H3™ Total Ankle Replacement System Receives FDA Premarket Approval

DT MedTech
The H3 was developed by Prof. Dr. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The H3 has been implanted in more than 20,000 patients outside of the U.S. since its first release in May 2000.
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Bioventus to Co-Develop Next Generation Placental Tissue Product for Knee Osteoarthritis with MTF Biologics

Bioventus
“Development of new orthobiologics offerings for osteoarthritis is a core focus for Bioventus and we are pleased to begin collaborating with MTF Biologics on a solution for knee OA that will offer symptom relief and potentially delay progression of the disease,” said Tony Bihl, CEO, Bioventus.
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Market Reports

Global Prosthetic Heart Valves Market Analysis 2015-2019 & Forecast to 2024

Market Analysis
The report analyzes the worldwide markets for Prosthetic Heart Valves in US$ by the following Segments: Tissue Heart Valves, Transcatheter Heart Valves, and Mechanical Heart Valves.
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Urological Catheters Markets, 2017-2018 & 2019-2025

Market Analysis
This urological catheters markets report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Middle East & Africa and Latin America. Annual estimates and forecasts are provided for the period 2017 through 2025. Also, a five-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research.
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European Magnetic Resonance Imaging Market 2019-2024 is Projected to Reach $3.99 Billion

Market Analysis
The Europe MRI market is projected to grow at a CAGR of 1.37% to reach US$3.999 billion by 2024, from US$3.686 billion in 2018 The...
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Hemodialysis Vascular Grafts Market Size Worth $276.5 Million By 2025

Market Analysis
Increasing number of patients suffering from chronic kidney diseases (CKD) and growing adoption of biological access products due to technological advancements in the field are some of the factors contributing to revenue growth. Higher number of renal impaired patients and limited availability of suitable kidney donors are promoting hemodialysis procedures in renal impaired patients, which in turn is expected to fuel the demand for vascular grafts over the forecast period.
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Global Radiosurgery Robotic Systems Market 2019-2025

Market Analysis
The report on the global radiosurgery robotic systems market provides qualitative and quantitative analysis for the period from 2017 to 2025.
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Non-Profit News

Jeff Shuren, M.D., J.D., Statement on FDA Efforts to Increase Transparency in Medical Device Reporting

NON PROFIT
U.S. Food and Drug Administration's Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products.
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AAOS Opposition Statement to Senate HELP Surprise Billing Proposal

NON PROFIT
President Kristy L. Weber, MD, “While the AAOS supports removing patients from the middle of out-of-network billing disputes, we strongly believe that imposing an insurer-controlled rate is not the solution. The Lower Health Care Costs Act represents an unprecedented transfer of market power by the government to insurers and directly threatens the independent practice of medicine."
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ACC Names First Director of Diversity and Inclusion

NON PROFIT
The American College of Cardiology welcomes Ranna Parekh, MD, MPH, as its first Director of Diversity and Inclusion. By working with the ACC Task Force on Diversity and Inclusion and other societies and organizations, Parekh will lead and expand the College’s diversity and inclusion initiatives to create a more diverse and inclusive environment within the field of cardiovascular disease and strive for a fully inclusive organization and profession.
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Executives

Innovatus Imaging Expands Staff

Executives
CEO reports substantial personnel growth in the company’s Pittsburgh office, the company’s Center of Excellence for MRI Coil Repair and Radiography.  To adjust to client needs and the growing demand for sustainable MRI coil repairs, the following personnel updates have been made.
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Dr. Americus Reed II joins Somatix Advisory Board

Executives
Dr. Americus Reed II is an identity theorist & researcher in the field of marketing. He is the Whitney M. Young, Jr., Professor of Marketing at the Wharton School, University of Pennsylvania, where he has served on the faculty for two decades.
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Claude LeDuc to Replace Dr. Brent Norton as President and Chief Executive Officer KIRKLAND, QC

Executives
"I am pleased to announce that Claude LeDuc is joining our company," stated Steve Saviuk, Chairman of the Board of Directors of Ortho RTi. "Mr. LeDuc has an outstanding track record of accomplishment in growing private and publicly traded bio-pharma companies. He is taking the helm of Ortho RTi as the Company is commencing preparation for its first human trial to test its lead biopolymer, Ortho-R, for the treatment of Rotator Cuff injuries. Under his leadership we look to the future with excitement and confidence."
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John Toomey Appointed Vice President of Growth and Innovation of RMS Medical Products

Executives
Toomey brings to RMS over 30 years of medical device industry experience as an executive, patent officer, inventor, board member, and advisor. 
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Tad Schweikert: New COO at SCWorx Corp

Executives
“It’s an honor to have the opportunity to join SCWorx, a company I have admired and watched closely,” said Schweikert.
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