Medical Device News Magazine

Medical Device News Magazine is Monitoring the Latest COVID-19 News

Saturday, July 4, 2020

COVID-19

All countries

11,293,410

Total confirmed cases

Updated on July 4, 2020 2:47 pm

USA

2,918,726

Total confirmed cases

Updated on July 4, 2020 2:47 pm

USA

132,209

Total deaths

Updated on July 4, 2020 2:47 pm

Assisting the World Through Advanced Robotic Technology

Founded in Shimizu, Japan in 1976, Intelligent Actuator Incorporated (IAI) has over forty years of experience in the design and manufacture of customized medical and industrial robotics. Built on “Quality and Innovation,” IAI is a leader in the research and development of advanced energy-efficient and affordable Cartesian, SCARA, and Tabletop robots. From entry-level to high-speed models, IAI provides complete programmable systems and components to fulfill any and all of your medical testing and industrial production needs

Journey Towards Accurate and Fast Non-Invasive Mapping of Heart Bio Signals

Authors: Rakesh Sethi, Vice President, General Manager Advanced Product Development, TDK U.S.A. Corporation, Yasushi Terazono, Sr. Scientist, TDK U.S.A. Corporation, and Tomohiko Shibuya, Manager of PicoTesla Sensor Solutions, TDK Corporation

Study Demonstrates that AI Technology is Better Predictor of Stroke than Traditional Methods

The study, led by Dr. Brajesh Lal, Director of both the University of Maryland’s Center for Vascular Diagnostics and the NIH Vascular Imaging Core Facility, with participation by the Cleveland Clinic, Weill-Cornell, and Case Western, sought to improve prediction of Major Adverse Neurological Events (MANE; stroke, transient ischemic attack, and amaurosis fugax) by applying AI to traditional carotid imaging using the Elucid Bio vascuCAP software.

The Impact of COVID-19 on Clinical Trials: Challenges and Opportunities

The COVID-19 pandemic is undoubtedly having a disruptive effect on health systems and healthcare delivery worldwide. In this article, Dr. Laura Moro-Martin addresses several challenges including clinical research, interactions with sponsors, CROs and much more.

FDA Updates

FDA1

COVID-19 Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines

June 30, 2020

The guidance, which reflects advice the FDA has been providing over the past several months to companies, researchers, and others, describes the agency's current recommendations regarding the data needed to facilitate the manufacturing, clinical development, and approval of a COVID-19 vaccine.

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Executives on the Move

EXECUTIVES

Michael Enxing joins PainTEQ Board of Directors

July 1, 2020

With nearly three decades of executive experience, Enxing provides commercial know-how and strategic insight for medical device businesses.

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Association News

NON PROFIT

The Future of Colorectal Cancer Care is Precision Medicine

June 25, 2020

The Colorectal Cancer Alliance shares new life-saving information with colon cancer and rectal cancer patients and caregivers.

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Hospitals in the News

HOSPITALS IN THE NEWS

Long Island’s First LGBTQ Transgender Center Opens

June 25, 2020

The Northwell Health Physician Partners LGBTQ Transgender Health Program, located at 410 Lakeville Road, features four exam rooms, eight offices/consultation rooms, and two gender-neutral restrooms.

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Consumer Health

CONSUMER CORNER

EoS Fitness and Black Box VR Join Forces

June 26, 2020

Launching this summer in four EoS Fitness locations across Arizona and California, EoS will be the first national gym brand in the U.S. to offer its members a Black Box VR workout that combines dynamic resistance training and high-intensity cardio with sensory and immersive technology.

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Breaking Medical Device News

SonoScape Flagship 4-LED equipped FHD Endoscopy System

July 3, 2020

The new SonoScape Flagship 4-LED equipped FHD Endoscopy System was used in two live demos of the marathonlike endoscopy Live conference. Cases were performed respectively by Prof. Zhou Ping-Hong, a global elite doctor in Shanghai Zhongshan Hospital of Fudan University in China, and Dr. Roberta Maselli in Humanitas Hospital Milan, Italy.

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

July 3, 2020

As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification. Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm.

Transforming the Performance of Batch Production

July 3, 2020

Martin Gadsby, Director at Optimal Industrial Technologies, looks at how PAT can bring batch-oriented plants to the next level of productivity.

LuViva Advanced Cervical Scan Awarded New CE Mark with Expanded Claims

July 1, 2020

The new CE Mark includes expanded claims for the use of LuViva by physicians for the early detection of cervical cancer.

Results of First Clinical Study Using Patient-Specific Brain Aneurysm Models for Pre-Procedural Rehearsals Announces BIOMODEX®

July 1, 2020

Published in the Journal of NeuroInterventional Surgery (JNIS) this month, the findings demonstrates how use of the 3D printed aneurysm models for pre-procedural rehearsal allows physicians to rehearse for procedures more accurately and reliably.

Carag Receives U.S. FDA IDE Approval for Its Carag Bioresorbable Septal Occluder

July 1, 2020

The CE-marked Carag Bioresorbable Septal Occluder is the first-ever transcatheter septal occluder with bioresorbable, metal-free framework.

NuvoAir Announced Publication of Two Abstracts from the Royal Brompton Hospital, London, UK

July 1, 2020

The abstracts, published in the June supplement of the Journal of Cystic Fibrosis, were originally submitted to the 2020 European Cystic Fibrosis Conference in Lyon, France, prior to its cancellation.

An Instant Bladder Cancer Scan Could Save Thousands of Lives

July 1, 2020

A European photonics research team is developing a new endoscope to scan for the early signs of bladder cancer using multi-wavelength lasers. The scanner will provide instant, non-invasive, precise, and detailed information to determine what stage and grade that a tumor has reached and provide early diagnosis.

Gynesonics Announces Publication of CHOICES

June 30, 2020

Sonata demonstrates significant advantages in reducing procedure time, length of stay and procedure-related costs compared to myomectomy.

Kardium Receives CE Mark for Globe® Mapping and Ablation System

June 30, 2020

The Globe® Mapping and Ablation System can now be used by electrophysiologists across Europe to safely and effectively treat patients with AF.

IlluminOss Medical Receives FDA Clearance for Expanded Clinical Use for Pelvic, Clavicle and Small-Bone Fractures

June 30, 2020

The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market.

Feasibility, Safety, and Effectiveness of a Mobile Application Study Shows Datos’ TeleHealth Platform Improves Cardiac Rehab and Patient Adherence

June 30, 2020

Feasibility, Safety, and Effectiveness of a Mobile Application in Cardiac Rehabilitation study results revealed significant improvement in exercise capacity and consistent adherence among patients, with over 63% completing the goal of 150 minutes of aerobic exercise per week.

Ambu and Medical Advisory Fuel Medical Group Announce Partnership

June 30, 2020

“This is a perfect match that will enable both companies to expand their reach into new and growing markets,” said Juan Jose Gonzalez, CEO of Ambu A/S.

Activ Surgical Joins Qualcomm Smart Cities Accelerator Program

June 30, 2020

Participation to include a collaboration with Innominds to develop next-generation surgical sensing capabilities that will reduce preventable surgical errors and complications across the U.S. and globally.

Olympus Launches HookKnifeJ and TriangleTipKnifeJ

June 29, 2020

The HookKnifeJ is for the esophagus, stomach and colon and the TriangleTipKnifeJ is for the esophagus and stomach.

Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System

June 29, 2020

The new LUX-Dx™ Insertable Cardiac Monitor System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.

Orthofix Announces FDA Clearance and First Patient Implants of FIREBIRD SI Fusion System for Low Back Pain

June 29, 2020

The FIREBIRD SI Fusion System is implanted through a minimally invasive surgery that typically can be performed in about an hour and may lead to less time at the hospital and a faster recovery than a traditional sacroiliac joint fusion surgery. The procedure with the FIREBIRD SI Fusion System involves inserting two to four bone screws across the SI Joint to stabilize during the fusion process.

Envoy Medical Receives FDA Breakthrough Device Designation for its Fully Implanted Acclaim® Cochlear Implant

June 29, 2020

Unlike existing traditional cochlear implants that are partially implanted and have an external microphone and processor, if approved by the FDA, the Acclaim would be the first-of-its-kind cochlear implant without any external components to offer unique benefits to users and hopefully increase cochlear implant adoption and user compliance across the globe.

Intact Vascular Announces Positive One-Year Data from TOBA II BTK Clinical Trial in VIVA Late-Breaking Session

June 26, 2020

The one-year results, which successfully demonstrated sustained improvement in Rutherford category, toe-brachial index (TBI) and quality-of-life metrics following management of patients with post-PTA dissection with the Tack Endovascular System® (4F), in conjunction with excellent limb salvage and amputation free survival rates.

Elixir Medical Announces Outstanding 12-Month Data for DynamX Coronary Bioadaptor System, Demonstrating No Target Vessel Revascularization, No Thrombosis and Positive Adaptive Remodeling of the Artery

June 25, 2020

Data shows the DynamX Coronary Bioadaptor System is the first coronary artery implant that adapts to vessel physiology.

Dayzz Sleep App Announces Publication of the Findings From Clinical Trial to Validate Its Sleep Assessment Machine Learning Engine

June 25, 2020

The clinical trial was conducted in collaboration with the Johns Hopkins Center for Interdisciplinary Sleep Research and Education.

New Late-Breaking Data Highlight Impact of Abbott’s Minimally Invasive Structural Heart Therapies

June 25, 2020

The data included findings on the MitraClip™ system for transcatheter mitral valve repair and data on two first-in-the-world devices approved in the EU: the TriClip™ system* for transcatheter tricuspid valve repair and the Tendyne™ transcatheter mitral valve implantation system* for people needing a replacement mitral valve.

SIGNAFUSE® Bioactive Bone Graft Receives FDA Clearance

June 25, 2020

The biphasic mineral in SIGNAFUSE is composed of 60% hydroxyapatite and 40% beta- tricalcium phosphate; a ratio supported by multiple prospective2 and randomized controlled trials.3-5

ESPRIT Announces Extended Support for Mazak Smooth Ai CNC

June 25, 2020

ESPRIT produces machine-optimized, edit-free G-code programs, program optimization, and machine simulation for Mazak’s entire line of machine tools.

Polares Medical Closes a $40M Financing

June 25, 2020

Jacques Essinger, Ph.D., Chairman and CEO, said, "With this Series B financing, we intend to advance our clinical studies in Europe and the United States.”

Affluent Medical Announces €15.8 Million in New Financing

June 24, 2020

The investment was led by Truffle Capital through the Truffle Biomedtech FCPI Fund and Truffle Innov FRR France and other investors

SecurAcath Significantly Reduces Catheter-Related Infection Risk

June 24, 2020

The SecurAcath is the only subcutaneous catheter securement device that lasts the life of the line and can reduce catheter-related infections and other complications, dramatically decrease catheter dislodgement and migration, decrease catheter replacement costs, and lower total cost of patient care.

Okami Medical Announces Closing of $7.2M Series D Financing

June 24, 2020

The financing provides Okami, the second portfolio company of medical device incubator Inceptus Medical LLC, with capital to commercialize its innovative catheter-based technologies for peripheral vascular occlusion.

Biomerics Launches Online Store for Medical Balloons

June 24, 2020

Biomerics currently manufactures over 20,000 balloons per week that are sold as components or further processed into finished medical devices.

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