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Breaking Medical Device Industry News

Medical Device News Magazine Continues to Monitor COVID-19 Stats

All countries
18,851,791
Total confirmed cases
Updated on August 5, 2020 3:21 pm
USA
161,088
Total deaths
Updated on August 5, 2020 3:21 pm
USA
4,947,715
Total confirmed cases
Updated on August 5, 2020 3:21 pm

IAI Proudly Introduces TAA Tabletop Series Robots

“IAI is proud to be at the forefront of technology to assist the medical community in the battle against Covid-19 and any future health crisis,” says Kaz Haruna, National Sales Manager for IAI America.

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Device Industry Executive Views: The Launch of Thin Film Electrodes: A Defining Moment for Neurosurgery Patients and Physicians

Innovative thin film electrode technology is expected to reach the market soon, prompting medical specialists, healthcare executives and investors to take note of its potential benefits over current technology. Author Dave Rosa, President and CEO of NeuroOne Medical Technologies provides exceptional information and advice.

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FEATURE: Fields of Using Printed Circuit Board: Author Duncan Adams

Most of the medical devices have Printed Circuit Boards mounted on them. These Circuit boards help the practitioners to conduct various kinds of medical experiments.

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INTERVIEW: CEO of CareDx, Peter Maag, Discusses the Company's Commitment to Transplant Patients During the Pandemic and Beyond

Interview with Peter Maag, CEO of CareDx. Maag addresses patient transplant challenges, aid immune-compromised transplant patients, growth during COVID-19, and the future.

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FDA EUA Issued for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients

Devan Smith, a 42 Year Old Warehouse Worker from Pennsylvania Contracted COVID-19 in May and Benefited from the Unloading Effect of Impella

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Abbott Reports: First Enrollments in the TactiFlex PAF IDE Study Underway

The study will evaluate the performance of the investigational TactiFlex™ Ablation Catheter, Sensor Enabled™ for people whose AFib symptoms are unable to be managed by medication.

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United States Blood Glucose Meter Market Insights Report 2020-2027

MARKET ANALYSIS
United States Blood Glucose Meter Market Insights Report - The United States market for the blood glucose meter is primarily expected to be driven...
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FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal

FDA BRIEFS
"The FDA is finalizing guidance today that will help protect public health by reducing infants' exposure to inorganic arsenic, which has been associated with neurodevelopmental effects.
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Richard S. Walsh New CEO of CorVent Medical – Offers Three Years of Industry Experience

EXECUTIVES
Mr. Walsh comes with almost three decades in the industry, both with start-ups and large, global organizations, and brings a wealth of medtech and senior leadership experience. He joins CorVent as the team prepares to commercialize its RESPOND-19™ ventilator and position the company as an innovator in reliable, lifesaving ventilators that efficiently address overflow ventilation needs. 
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Hologic Launches ‘Back to Screening’ Campaign to Encourage Women to Prioritize Mammograms Delayed due to COVID-19 Pandemic

CONSUMER CORNER
Hologic’s Back to Screening campaign features a page where visitors can sign up for a reminder to schedule their annual mammograms.
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AAOS Alarmed by CMS Proposal that Reduces the Value of and Access to Orthopaedic Care

NON PROFIT
“The AAOS urges CMS to reconsider the significant preoperative work that is required to make value-based care both cost-effective and high-quality and to refrain from finalizing both of these punitive cuts on the value of orthopaedic care.”
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Skokie Hospital Opens a New Spine Center Reports NorthShore University HealthSystem

HOSPITALS IN THE NEWS
The new spine center at Skokie Hospital will treat patients with back and neck conditions, some of the most common causes of pain and disability in the United States.
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BREAKING MEDICAL DEVICE NEWS

CorMatrix Cardiovascular Receives European Community and U.S. Patent Claim Allowances for Polymer Drug Delivery Prostheses

CorMatrix® Cardiovascular Inc.
The European and U.S. Patent allowances will further enhance CorMatrix's growing synthetic polymer and ECM (Extracellular Matrix) delivery platforms, which, in addition to PGS, includes poly(urethane urea), polylactide (PLA), poly(e-caprolactone) (PCL) and polyglycolide (PLGA) compositions and structures.
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CardioMech AS Secures $18.5M Series A for its Transcatheter Mitral Valve Repair Technology

CardioMech AS
CardioMech AS is developing a catheter-based mitral valve repair technology as an alternative to open-heart cardiac surgery by placing its artificial chord(s) in the heart via a catheter to reduce or eliminate mitral regurgitation without opening the chest, stopping the heart, or going on heart-lung bypass.  
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SIROS™ System for Advanced SIR-Spheres® Resin Microspheres Delivery Launched

Sirtex Medical
Sirtex Medical reports SIROS™ offers a visual, intuitive and versatile option for interventional radiologists to deliver SIR-Spheres® to patients with liver cancer.
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Impressive $4.9 Million Department of Defense Contract Is Awarded Pall Corporation

Pall Corporation
When the new line opens in the fall 2021, Pall's ventilator filter production capacity will increase from 485,000 units per month to 650,000 units per month – allowing Pall to help meet the growing demand in the U.S. for ventilator filters driven by COVID-19.
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Ethicon’s ECHELON Powered Stapler with Gripping Surface Technology Published

ETHICON
In the latest study, researchers found bleeding complication rates were up to 73% lower in the ECHELON Powered Stapler with Gripping Surface Technology reloads group than they were in the Signia group (0.61% vs. 2.24%).
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AuroLase® Pivotal Study Update: Four Clinical Trial Sites Added Notes Nanospectra Biosciences

Nanospectra Biosciences
The AuroLase pivotal study follows the successful first-in-human pilot study that enrolled 46 subjects at three U.S. sites. Pandemic related delays to the one-year end of study biopsies for the final subset of feasibility study subjects should be resolved within the next several weeks and, consequently, final results of the feasibility study are expected later this year.
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Siemens Healthineers Obtains First FDA EUA for Semi-Quantitative Antibody Test

Siemens Healthineers
This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent.
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Adagio Medical Reports Pre-clinical Effectiveness Combining their Existing Ultra-low Temperature Cryoablation Catheter with Pulsed Field Ablation in a Single Pulsed Field Cryoablation Catheter

Adagio Medical Inc.
"Our goal is to lead the innovation and development of true continuous, transmural lesions anywhere in the heart.  Our primary technologies under development have been ultra-low temperature cryo (ULTC) and electroporation (PFA)," said Olav Bergheim, President and CEO of Adagio Medical.
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CAPS Medical, MEDX Xelerator’s Portfolio Company, Raises $3.5 Million Series A

MEDX Xelerator
“CAPS was one of the first companies to join the incubator. CAPS CEO Ilan Uchitel has led his team, with the support of the incubator and its partners, to achieve all of its milestones, far ahead of schedule,” said Shai Policker, CEO of MEDX Xelerator and a CAPS Medical board member.
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JEOL Announces Release of the New Scanning Electron Microscope JSM-IT700HR

JEOL Ltd.
Based on their award-winning predecessor of “InTouchScope™” series SEMs, the JSM-IT700HR is equipped with their in-lens Schottky field emission electron gun (FEG). This new powerful SEM satisfies the needs for observation and analysis of further miniaturized materials in daily laboratory operation.
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Sotera Health Acquires Canadian-based Iotron Industries

Sotera Health
The acquisition of Iotron Industries expands the company's electron beam (EBeam) footprint and adds new expertise to its Sterigenics business.
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InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads Receive FDA Approval

InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads make Medtronic the only company to offer patients and physicians a choice in SNM systems to match their preferences, lifestyle and treatment goals.
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Todos Medical Announces Partnership with Pathnova Laboratories

Under the terms of the agreements, PATHNOVA will be responsible for the further development and commercialization of the Todos Tests in Singapore, and Todos Medical will assist PATHNOVA in commercializing its nasopharyngeal cancer tests through its affiliates in the United States and Singapore.
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Neuroform Atlas® Stent System Granted an Expanded Indication

Stryker
Neuroform Atlas® Stent System is the first and only adjunctive stent approved for use in the posterior (back of the brain) circulation. Aneurysms in the posterior circulation rupture more frequently and are generally more difficult to treat.
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NeoTract Designates Dr. Joshua Langston as UroLift® Center of Excellence

The designation recognizes that Dr. John Langston has achieved a high level of training and experience with the UroLift® System and demonstrated a commitment to exemplary care for men suffering from symptoms associated with Benign Prostatic Hyperplasia (BPH), also known as enlarged prostate.
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CytoSorbents Awarded $4.4 Million Contract by the U.S. Department of Defense

CytoSorbents reports the HemoDefend-BGA filter is designed to enable "universal plasma", or plasma that can be administered to anyone regardless of blood type, and to improve the safety of whole blood transfusions, by the rapid and efficient removal of anti-A and anti-B antibodies from these two blood products.
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MolecuLight Reports 10 Clinical Posters and Video Presentations at SAWC

MolecuLight Inc.
"We are thrilled to have had a record number of MolecuLight-based clinical posters and presentations, from so many wound care professionals and settings, be included at the SAWC's Virtual Session", says Anil Amlani, MolecuLight's CEO.
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FDA Grants An EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms

The EUA amendment extends the RT-PCR platform authorization from the Applied Biosystems (ThermoFisher Scientific) QuantStudio™ Dx to include Applied Biosystems’ QuantStudio™ 5 Real-Time PCR system (“QS5”). The amendment also authorizes the use of the Hamilton STARlet robotic automation in conjunction with the Omega Bio-tek Mag-Bind® viral RNA Express kit to speed the process of extracting viral RNA from specimens and drive greater testing throughput.
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GE Healthcare to Distribute Osprey Medical’s Technology to Address Angiography Based Acute Kidney Injury

Under the four-year agreement, GE Healthcare will commercialize Osprey’s DyeVert portfolio which reduces the amount of contrast that reaches the kidney (40% average reduction) with no compromise in image quality.
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