Monday, June 1, 2020

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

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

Medical Device Industry and The Role of the FDA In the USA During the Covid-19 Pandemic

By: Dr. Archana Nagarajan Freelance Scientist at Kolabtree

New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women

FDA approval was granted to Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Douglas J. Batdorff Appointed New Vice President of Kewaunee Scientific Manufacturing Operations

Mr. Batdorff will have responsibility for all of Kewaunee's domestic manufacturing operations.
6,315,280
Confirmed cases
Updated on June 1, 2020 12:59 pm
374,928
Total deaths
Updated on June 1, 2020 12:59 pm
2,873,585
Total recovered
Updated on June 1, 2020 12:59 pm
3,066,767
Total active cases
Updated on June 1, 2020 12:59 pm

ASSOCIATION NEWS

New Leaders at ASTCT and CIBMTR Provide Guidelines and Measures for Combating COVID-19 and Protecting Transplant Patients

The ASTCT and CIBMTR work hand-in-hand to collect and share data used to improve both quality of transplant care and survivability.

HOSPITALS IN THE NEWS

NJHA Charts Rise and Fall of COVID Hospitalizations; Peak Occurred April 14

New Jersey reported its first COVID-19 case on March 4. The rapid rise of the virus in New Jersey culminated on April 14, when the state's hospitals experienced peaks.

CONSUMER CORNER

Mark Cuban In the News – Backs Startup ‘ChatableApps’ Launches World’s First Universal Hearing Aid

ChatableApps’ Groundbreaking Neuroscience-led AI, turns your smartphone into a next generation hearing aid, without the need for a hearing test.

BREAKING MEDICAL DEVICE NEWS

CURE™ OPEL-L (S) system Receives FDA Clearance Reports Meditech Spine

With this approval, Meditech will now offer an Interbody/Plate assembly for the anterior lumbar spine. By adding the Opel™-L (S) plating option to the CURE™ LP product line and pairing it with the Talos® A (HA) interbody system, surgeons now have a nearly limitless opportunity to ideally accommodate individual patient anatomy.

Ezra Raises $18M Series A

The AI cancer screening startup will use the funding to expand its suite of medical imaging AIs, and launch the Ezra COVID 360 offering.

Impella RP as Therapy for COVID-19 Patients with Right Heart Failure Receives FDA EUA

Impella RP is a temporary heart pump that provides circulatory support for patients who develop right side ventricular failure.

FlowSense™, a Wireless, Noninvasive Flow Sensor, Has Been Granted Breakthrough Device Designation by the FDA

The novel technology, formed out of the award-winning John A. Rogers Research Group at Northwestern University (Evanston, IL), is designed to rapidly monitor ventricular shunt function in patients with excess cerebrospinal fluid caused by hydrocephalus

DIRECTSENSE™ Technology Launched by Boston Scientific

Available on the RHYTHMIA HDx™ Mapping System, the DIRECTSENSE Technology, which received U.S. Food and Drug Administration approval in April, is the only tool to monitor changes in local impedance – electrical resistance – around the tip of the INTELLANAV™ MiFi Open-Irrigated (OI) ablation catheter, offering physicians an additional measurement of therapy effect during an ablation.

Department of Defense Adds Lipogems to Their Arsenal

Through its partnership with Buffalo Supply, Inc., the Lipogems Sports Medicine System is now available within the U.S. Department of Defense (DoD) to help over 2.3 million service members that may be suffering from orthopaedic and wound issues.

Arterys Receives Seventh US FDA Clearance

Arterys said it will deploy this new round of financing to broaden the Arterys ecosystem, comprising a broad set of partners on the new Arterys Marketplace working together to deliver clinical applications built on the Arterys cloud-native viewer and platform.

Plasma Therapy Accelerator – ‘SARS-Hunter” a New Solution for Better Antibody Therapy for All COVID-19Patients

SARS-Hunter gives the possibility to hospitals to isolate the antibodies from plasma to be given as therapy and increases the chances of success of treatment, while reducing the side effects of plasma therapy given today.

Next Generation Sonata® System 2.1 Receives FDA Market Clearance

The new advances in Sonata® System 2.1 include a new integrated treatment device design that enables all procedure steps to be performed on the sterile field and in the palm of the physician’s hand.

RefleXion Announces Clinical Collaboration to Evaluate Biology-guided Radiotherapy With Merck’s KEYTRUDA® for Certain Late-Stage Cancers

The aim of the clinical collaboration between RefleXion and Merck is to establish whether treating multiple tumors with BgRT, a novel external beam radiotherapy treatment modality in development is safe and amplifies KEYTRUDA’s therapeutic effect.

First Patient Enrolled in Phase 1 Natural Vascular Scaffolding Clinical Trial

The therapy is designed to open vessels and keep them open without the use of permanent implants in the treatment of peripheral artery disease (PAD) of the lower extremities, a painful and debilitating condition affecting over 200 million people worldwide.

Centricity Vision Introduces New Name and Leadership Team

“Centricity Vision” reflects the company’s core competency, embodied by its ZEPTO® Precision Cataract Surgery Platform, in creating precise, consistent, visual axis-centered capsulotomies.

Non-Pharmaceutical Clinical Trial Starts Using Photobiomodulation to Treat Intubated COVID-19 Patients

Approved by the Ministry of Health in Brazil, a group of international physicians and scientists are in the early stages of data collection utilizing Multi Radiance Medical’s handheld super pulsed laser therapy devices to improve the condition of patients.

Conventus Orthopaedics Acquires Flower Orthopedics

Conventus intends to continue to aggressively pursue new and innovative orthopedic technologies that are clinically relevant to surgeons, hospitals, and ambulatory surgery centers. 

MediCapture Launches The TRS Pro Wireless Medical Tablet Recorder System

TRS Pro™, is a new and convenient approach to how surgeries are recorded and managed.

Siemens Healthineers Now Shipping Worldwide Total Antibody Test and Molecular Test Kit for COVID-19 with Expanded Capacity

The antibody test is now available on the largest installed base in the U.S. and one of the largest in the world with 20,000 Siemens Healthineers systems installed worldwide.

Vexos to Manufacture and Deliver 10,000 MVM Ventilators to the Government of Canada

The Government of Canada's continuing support for companies producing critical medical supplies will enable Vexos to manufacture and deliver these much-needed ventilators that will assist in the treatment of patients affected by the COVID-19 virus.

5-year Multi- Center Clinical Data for the Actifit® Meniscal Scaffold Published n the American Journal of Sports Medicine: Receives FDA Breakthrough Device Designation

Actifit meniscal scaffold has been implanted in more than 4000 patients with irreparable meniscal cartilage damage in 30 countries worldwide and has now been published in 25 peer-reviewed clinical journals.

uMR OMEGA Cleared by FDA Now Available in U.S. Market

With the widest bore in the market at any field strength, uMR OMEGA provides a unique, patient-centric experience designed to accommodate a wide range of patients.

Velano Vascular Makes Streamlined Virtual Training Tools Widely Available to U.S. Hospitals to Aid in the COVID-19 Response

Initially developed with existing partners utilizing its PIVO™ needle-free blood draw device in the fight against COVID-19, the platform is now available for additional hospitals and systems in need of streamlined care. The company is based in San Francisco, CA.

Precision Spine® Reports the National Release of the Reform® Ti HA Coated Pedicle Screw System

Patent-pending Reform Ti HA Coated Pedicle Screws have a hydroxyapatite coating applied to the screw threads that is designed to enhance the amount of fixation possible between the pedicle screw and the surrounding bone in osteoporotic patients.

SETi Releases Portable Air Purifiers with Violeds Technology for New Coronavirus Disinfection in Early June

Violeds technology has been proven to sterilize 99.9% of new coronavirus in 30 seconds according to testing results.

New Options for Temperature Check Verification and No-Touch Touchless Touchscreen Technologies and Resources Available From Kiosk Manufacturer Association

Kiosk Manufacturer Association. KMA consists of companies from all over the world that provide kiosk and self-service technology, hardware and software to enable unattended access for customers and employees. Whether for retail, theme park, healthcare or corporate "back to work" situations, being able to provide some sort of qualified testing is the first step for entire industries and all-size businesses everywhere to open safely and help bend the COVID-19 curve.

TransEnterix Announces Sinai Health System in Chicago to Initiate Program with the Senhance Surgical System

“Our team is excited that Sinai Health System has chosen to add the Senhance Digital Laparoscopy Platform to its minimally invasive surgery program,” said Anthony Fernando, president and chief executive officer at TransEnterix. “In the midst of the challenging times posed by COVID-19, hospitals are looking to the future and continue to seek more advanced and cost-effective technologies to treat their patients undergoing surgery. We are thrilled to partner with the excellent surgical team at Sinai Health System.”

Sinovac Secures $15 Million in Funding to Accelerate COVID-19 Vaccine Development

The funds to be used to further the development of an inactivated vaccine against COVID-19 named CoronaVac. The two investors each loaned USD $7.5 million in the form of a convertible loan that bears interest, or, at the investor’s election, converts into 7.5% of the total equity interest of Sinovac R&D.

First Patient Enrolled to the TIGER Pivotal Clinical Study

5/16/18: "We are pleased to have enrolled the first patients and to have a leadership role in the TIGER study. Stentrievers are now the gold standard for treating ischemic stroke, and TIGERTRIEVER is a new generation stentriever. Its unique design will hopefully show that it addresses the limitations of current devices and will improve patient outcomes," stated Dr. Rishi Gupta.

Labs@Home™ Facilitates Outpatient Management of Kidney Transplants During COVID-19

TruGraf, the only blood test approved by CMS for surveillance to rule out "silent" subclinical acute rejection (subAR) in kidney transplant recipients with stable graft function, has been recognized as crucial to reducing risk in outpatient management after a kidney transplant during COVID-19 in a recently published article from Yale University.

EarlyCDT Lung Partnership Contract Signed Reports Oncimmune Holdings

With one of the world’s largest pharmaceutical companies, Oncimmune will further evaluate EarlyCDT Lung for the detection of lung cancer in at-risk patients. The initial phase of the collaboration will assess the utility of Early CDT Lung test at detecting incident lung cancer cases in a screening setting.

OrthogenRx Announces Response in The Journal of Bone and Joint Surgery

The recently published response counters this position and addresses some recently reported economic and medical benefits not acknowledged within the AAOS CPGs.

Shuwen Announces Peer-Reviewed Publication of Data Demonstrating the Potential of its Breakthrough Preeclampsia Detection Device in Unselected Women

The paper, entitled “Late pregnancy screening for preeclampsia with a urinary point-of-care test for misfolded proteins”, was written by collaborators from China Medical University's Shengjing Hospital and Columbia University Medical Center in New York and demonstrates the ability of the test to detect preeclampsia at a high level of accuracy in women admitted to the hospital for any reason. The findings included over 1,500 women and were published in the peer-reviewed journal PLOS One.

Early Identification of Acute PE Identified with EarlySense Technology

The report includes findings from a case study at Hebrew Home of Riverdale by RiverSpring Health showing that skilled nursing facilities incorporating contact-free, continuous patient monitoring can potentially aid in the early identification of acute changes in patient deterioration and rapid life-threatening treatment interventions.

Smith+Nephew Launches New JOURNEY™ II Unicompartmental Knee System

JOURNEY™ II Unicompartmental Knee System provides a highly personalized approach to partial knee arthroplasty, via a modular, two-tray configuration, which may drive value and cost reduction in sterilization costs through a reduced OR footprint3-4 and instrumentation that can be customized to match a familiar surgical flow.

UAE Develops a Rapid Coronavirus Laser Testing Technology

This break-through will enable ‘Mass-scale screening’, changing the whole dimension of tracing.

DermTech PLA Included in Peer Review Article of Novel Molecular Technologies for Melanoma Management with Potential to Address Current Gaps in Diagnostic Accuracy and Prognostication

Since its launch in 2016, the DermTech PLA, DermTech’s non-invasive adhesive patch test for melanoma detection, has been used to assess more than 50,000 lesions and remains the first and only non-invasive gene expression test in dermatology, providing objective genomic data to help guide clinical decisions.

Publication Demonstrates Ability of Sera Prognostics’ PreTRM® Biomarker Test as a Predictor of Adverse Pregnancy Outcomes

The results of the study, which were selected for a podium presentation at the 40th Annual Pregnancy Meeting of the Society for Maternal-Fetal Medicine in February 2020, demonstrate that the company’s PreTRM® biomarker test can be used to predict very preterm birth, (infants born before 32 weeks of gestation) as well as increased length of neonatal hospital stay and severe adverse neonatal outcomes.

Positive Two-Year Data from the ALPS Registry of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System

The ALPS Registry is a multi-center, retrospective study conducted at centers in Alkmaar, Netherlands; Leipzig, Germany; Paris; and Singapore encompassing 32 end-stage – or “no-option” – CLTI patients.

Advanced Biological Laboratories Receives CE-IVD Registration for its SANGER and for its NGS DeepChek®-HIV Genotyping Drug Resistance Assays

Intended to be used on HIV-1 Group M viruses from patients diagnosed with HIV infection, the assays deliver standardized, open and flexible solution suited to clinical settings performing sequencing through Capillary Electrophoresis and Next Generation Sequencing (NGS) systems.

Laird Thermal Systems Releases Its Next Generation of Eco-Friendly Recirculating Chillers for Precise Temperature Control of Analytical, Medical and Industrial Equipment

The new chiller utilizes high-performance variable speed motors for noise reduction, lower room heat input and reduced energy consumption by up to 50% compared to conventional compressor-based systems.

New Medical Device Commercialization Firm Announces Launch

Harrison Bay Life Sciences is headquartered in Chattanooga, Tennessee, and recently announced the growth of its business that aids medical device companies seeking a commercialization partner who can bring innovative medical products and services to market.

Impella RP as Therapy for COVID-19 Patients with Right Heart Failure Receives FDA EUA

Impella RP is a temporary heart pump that provides circulatory support for patients who develop right side ventricular failure.

Ortho Clinical Diagnostics Receives 2nd Antibody CE Mark

The company are trusted partners of hospitals, hospital networks, blood banks, and labs around the world, serving the clinical laboratory and transfusion medicine communities with customized solutions that enhance clinical outcomes, improve lab performance, overcome staffing challenges and better manage costs.

Sommetrics Receives ISO 13485:2016 Certification

As a result of the ISO and MDSAP certifications, the company is now able to apply to HealthCanada for market clearance of the aerSleep® device targeted for the treatment of obstructive sleep apnea

Successful Diagnostics of Antibodies: Optics Balzers AG has Further Developed Optical Dielectric Filters in the UV Spectrum

The company reports their optical filters, which enable the excitation and the detection of signals in the UV range, can be adapted to specific substances.

New Directional Cannula Provides More Flexibility and Control to Balloon Kyphoplasty Procedures

The Kyphon Assist™ Directional Cannula allows physicians greater control when inflating the bone tamp while also increasing height restoration capability compared to a traditional balloon kyphoplasty cannula

Pulmonx Announces National Reimbursement in France for Zephyr Endobronchial Valve

The Zephyr Valve procedure, done through a simple bronchoscopy with no incision or cutting, is clinically proven to improve patients’ breathing, exercise capacity, and quality of life, without the risks of major surgery.

Live Virtual Demo of the Harmony SHR: New Upper Body Robotic Rehabilitation System

Harmony SHR works with a patient's scapulohumeral rhythm (SHR) to enable natural, comprehensive therapy for both arms. When combined with Harmony SHR's Weight Support mode, this unique shoulder design may allow for earlier initiation of post-stroke therapy.

Rabin Medical Center Announced They Will Initiate Clinical Trials to Test Feasibility of Exero Medical’s Wireless Anastomotic Sensor

Researchers at Rabin Medical Center will use Exero’s system to collect data from the sensor during low anterior resection surgery. The results of the trial will enable the company to refine its detection algorithms based on real-life data.

A New Type of CPR Announces CPR Therapeutics Inc.

These studies, undertaken at the Halperin Cardiology Bioengineering Laboratory at the Johns Hopkins Hospital, confirmed the Company’s foundational concept that multiple CPR pump mechanisms can be combined to produce dramatic improvements in hemodynamics.

PASCAL PASCAL Transcatheter Valve Repair System Receives European Approval For Tricuspid Repair

The PASCAL system is indicated in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation.

Inari Medical Launches Initial Public Offering

Inari is offering 7,333,000 shares of its common stock. In addition, Inari expects to grant the underwriters a 30-day option to purchase up to an additional 1,099,950 shares of its common stock.

Zebra Medical Vision Secures its 5th FDA Clearance

Their latest AI solution automatically identifies findings suggestive of compression fractures, enabling clinicians to place patients that are at risk of osteoporosis in treatment pathways to prevent potentially life-changing fractures.

Electronic Eyeglasses to Stop Myopia in Children by Kubota Vision Introduced

Results from the clinical study demonstrated that axial length decreases with the application of projected myopically-defocused images in the test eye compared to the control eye, which has not been reported in the literature.

Activ Surgical Introduces New Surgical Intelligence and Sensing Platform to Revolutionize Surgery

ActivEdge, an artificial intelligence (AI) and machine-learning (ML) platform, is designed to provide critical real-time intelligence and visualization to improve patient outcomes, avoid preventable surgical errors and complications, and provide significant overall savings to healthcare systems. The platform and its associated products will be initially available in the U.S. market, with plans to commercialize globally in 2021.

Balt Begin the STEM Trial: Receives IDE Approval From the FDA

The clinical trial is a prospective, randomized controlled trial.

COVID-19 Patients at Higher Risk of Dangerous Blood Clots Reports Sky Medical Technology

With VTE recognized as a major contributor to COVID-19 multi-organ failure, anticoagulation is critical and drug prophylaxis is the primary intervention, especially for immobile patients on ventilators at risk of VTE in ICU. Similar increases in thrombotic risk were seen with H1N1m influenza (Swine Flu).

Nevro Announces CE Mark Approval of Senza® Omnia™ Spinal Cord Stimulation System to Treat Chronic Pain

Omnia™ Spinal Cord Stimulation System is a completely new SCS platform and consists of a number of new components.

Lenovo™ Launches Virtual Rounding for Healthcare Providers

The Lenovo™ Virtual Rounding solution includes a Lenovo ThinkSmart View, an appliance for Microsoft Teams, a HIPAA-compliant collaboration and a communication platform designed for healthcare and businesses.

Publication of TOBA III Clinical Trial Results in the Journal of Vascular Surgery

“We are thrilled to have the TOBA III data published in the Journal of Vascular Surgery,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “This peer-reviewed article adds to the strong body of evidence supporting use of the Tack Endovascular System for focal dissection repair when treating lesions both above- and below-the-knee.”