Medical Device News Magazine

Located in the United States, Medical Device News Magazine reports the latest medical device, biotech and diagnostic industry news, including product launches, clinical trials, funding, acquisitions, FDA announcements, executives on the move and more.

Medical Device News Magazine Continues to Monitor COVID-19 Stats

Global Statistics
33,603,488
Total confirmed cases
Updated on September 29, 2020 8:58 am
USA
209,865
Total deaths
Updated on September 29, 2020 8:58 am
USA
7,363,152
Total confirmed cases
Updated on September 29, 2020 8:58 am

Authored Articles of Interest

Opeds and Other News
Amanda Chin, Senior Business Development Manager at Perspectum
By: Amanda Chin, Senior Business Development Manager at Perspectum

Chronic Liver Disease: The ‘Silent’ Disease Affecting 1 in 3 People with An Annual Mortality Rate of 2 Million

This is comparable to other chronic diseases with heavy socioeconomic burden, including diabetes (422 million affected, 1.6 million deaths), cardiovascular disease (540 million affected, 17.7 million deaths), and pulmonary disease (650 million, 6.17 million deaths). Read more.

Tracey Iraca, Executive Director, MDS Foundation, Inc.
By: Tracey Iraca, Executive Director, MDS Foundation, Inc.

Large International Study Pinpoints the Impact of TP53 Mutations On Blood Cancer Severity

Having Two Mutated Copies of the TP53 Gene As Opposed to a Single Mutated Copy Is Associated with Worse Outcomes in Myelodysplastic Syndrome and Acute Myeloid Leukemia. Read more.

Trudy McKanna, MS, CGC, Director of Medical Education, Natera

Paul R. Billings, MD Ph.D., Chief Medical Officer, Natera

Addressing the Silent and Deadly Rise of CKD with Genetic Testing

Genetic technologies continue to advance. Authors provide insight. Read more.

DEVICE NEWS: HIGHLIGHTS

T2 ICF Intramedullary Nailing System Offers Surgeons New Option for Patients Suffering from Serious Foot Conditions Reports Stryker

T2 ICF ICF Intramedullary nailing system offers a solution for patients suffering from serious foot conditions such as Charcot foot—a condition associated with diabetes resulting in poor bone quality, possible nerve damage and potential foot ulcers.

ACURATE neo2 Aortic Valve System Launches in Europe

This next-generation transcatheter aortic valve implantation (TAVI) technology is a new platform designed with a number of features to improve upon the clinical performance of the original ACURATE neo platform.

2 of 3 Leading COVID-19 Vaccine Initiatives utilizing Generis’s Life Science Platform, CARA

The company reports the US-driven international initiative to support the rapid development, manufacturing, and distribution of COVID-19 vaccines is progressing with many promising efforts to move towards Phase 3 clinical trials.

VersaWrap Nerve Protector Receives 510(k) Clearance Reports Alafair Biosciences

VersaWrap Nerve Protector is an ultrathin, sutureless, bioresorbable hydrogel implant ideally suited for covering and protecting peripheral nerves.

First-in-Human Implantation of Saturn Transcatheter Mitral Valve Reported Successful

The Trans-Apical TMVR procedure was performed as part of an on-going European clinical trial on August 19, 2020 at Santaros Klinikos University Hospital in Vilnius, Lithuania with the Heart Team of Kęstutis Ručinskas, MD, Audrius Aidietis MD, Vilius Janušauskas, MD, and Valdas Bilkis, MD supported by Paolo Denti, MD and Stefano Stella, MD.

PURPLESUN Battles the Invisible Enemy – COVID-19 – There is Light

The company designs and manufactures hospital-grade mechatronic systems that are user friendly and provide a special type of Focused Multivector Ultraviolet (FMUV) light technology, for the purpose of disinfection in 90 seconds.

Pounce Thrombus Retrieval System Receives FDA Approval – Non-Surgical Removal of Thrombi and Emboli from the Peripheral Arterial Vasculature

The Pounce Thrombus Retrieval System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

Medtronic Reports the First Enrollments in the ALLEVIATE-HF Clinical Trial to Evaluate the Ability of Reveal LINQ Insertable Cardiac Monitor

The LINQ device will alert clinicians if a patient is at high risk for a heart failure event, allowing time for a physician to adjust medications to enhance patient health.

OptiMesh Expandable Interbody Fusion System Receives FDA De Novo Grant Reports Spineology

The company is preparing for a Q1 2021 launch of the OptiLIF procedure utilizing the OptiMesh device. This procedure enables enhanced recovery and exceptional efficiency, and its outcomes are supported by prospective FDA IDE clinical data.

Strategic Partnership Allows for Marketing and Distributing Neauvia North America’s Plasma IQ

Plasma IQ is the latest advancement in aesthetics that delivers focused, controlled plasma energy to safely and effectively create micro-injuries on the skin, renewing, and restoring it.

MitraClip G4 Receives CE Mark Reports Abbott

The MitraClip G4 system provides physicians in Europe with enhancements to MitraClip's first-of-its-kind clip-based technology, building upon the device's proven delivery system.

Visualize: Redefining the Way for Medical Device Industry’s Approach to Closed-Loop Traceability

Greenlight Guru Visualize provides a platform for users to achieve closed-loop traceability through a fully connected quality ecosystem.

ATCOR Granted New Patent by the EPO for for the Company’s Proprietary SphygmoCor ® Technology Used in Cuff-Based Blood Pressure Devices

ATCOR's SphygmoCor® technology is the global standard for the non-invasive measurement of arterial stiffness in medical settings and is in use at all "Top 20 USA Hospitals" and more than over 4500 installations worldwide including major pharmaceutical companies and research institutions such as The Mayo Clinic, GlaxoSmithKline, AstraZeneca, Bayer, Scripps, Johns Hopkins, and Stanford University.

Release of Hexagon RS6 Laser Scanner Designed for High-Speed and Accuracy Scanning: Scans up to 1.2 Million Points/Sec with a Scan Rate of 300 Hz

The RS6 Laser Scanner scans up to 1.2 million points/sec with a scan rate of 300 Hz. The RS6 also has a wider laser stripe of 150 mm at mid-range and a visual guide that provides real-time feedback for stand-off distance.

Individuals Can Now Purchase a Test to Diagnose COVID-19 Online Without Visiting a Doctor’s Office

The test to diagnose COVID-19 online (QuestDirect COVID-19 Active Infection test*) is available online at QuestCOVID19.com.

SAFIRA® Anaesthesia Device Receives European CE Regulatory Approval

SAFIRA ® is a revolutionary new technology that transforms regional anesthesia into a one-person procedure, putting control in the hands of the anesthetist.

Transparent Face Mask (NOT FDA-Approved) Aimed at Making Personal Protective Equipment More Inclusive Launches

According to CLAiRUS, the new mask is a non-medical, fully reusable mask. It’s not FDA-approved as a medical device and it’s also not officially certified as PPE, but it has been specifically designed to help reduce the transmission of Covid-19.

New ER-REBOA™ PLUS Aortic Occlusion Catheter is Launched

September 16, 2020 Prytime Medical Devices, Inc. introduced its latest aortic occlusion catheter, the ER-REBOA™ PLUS this week at the American Association for the Surgery...

First Patient Enrollment in AAA-SHAPE Study – IMPEDE-FX Embolization Plug Devices Used for AAA Sac Filling During Elective EVAR Repair

The beginning of enrollment is a significant milestone for the Company as we continue to evaluate the potential of this novel application in aortic therapies.” The study will enroll up to 15 patients outside of the United States.

True Digital Surgery And Aesculap, Inc. Launch The Aesculap Aeos™ Robotic Digital Microscope

The Aesculap Aeos Robotic Digital Microscope adds state-of-the art software capabilities, providing a 3D digital visualization display, customizable Image Modes functionality, and fluorescence backlighting to enhance the precision needs that surgeons require for complex surgical procedures.

Telehealth is Only as Good as the Bandwidth in Many Critical Cases

On Telehealth: Timothy Kelley, CEO of Nautilus, said "Our rural and mobile doctors and professionals can use TeleRay in many situations." He explained that TeleRay could view modalities such as ultrasound in real-time from remote locations.

Expansion of Topical Wound Oxygen (TWO2) Product Family

AOTI notes the addition of a new larger extremity-chamber to the company's peripheral vascular disease-focused product line, allows for the application of TWO2 treatments for many more patients suffering from costly nonhealing chronic wounds.

Smith+Nephew and Avail Medsystems Team Up

Streamlining procedures in both hospitals and Ambulatory Surgery Centers (ASCs) is becoming increasingly important with operating room space at a premium.

PENTAX Medical Launches Innovative J10 Series Endoscopic Ultrasound Gastroscopes In the USA

The new PENTAX Medical J10 Series Ultrasound Video Gastroscopes deliver on both clinical and market needs, offering ergonomic design, renowned image quality and enhanced maneuverability as an EUS solution.

Secured Funding

Device & Diagnostic Companies Growth and Expansion

Hyprevention Raises New Financing to Commercialize Spinal Implant Product V-STRUT© in the USA

Hyprevention CEO Cecile Vienney notes, “We are delighted that our existing investors have shown confidence in our product development efforts and commercialization plans for the US market by increasing their investment in the company."

ImmVira Announces US$10 million Strategic Series B Plus Financing with SIIC Capital

This round of financing will be exclusively funded by Shanghai Healthcare Capital ("SHC"), managed by SIIC Capital, where Shanghai Pharma is one of the founding strategic cornerstone LPs.

Pressao Medical Completes Funding

The company has two products under development. The first is BP-ADJUST™, a new device in the form of a wristwatch that monitors blood pressure and heart rate and uses the information to deliver unique energy therapy to control BP. The second product is BP-ADJUST™ CV.

Acquisitions

Mergers

Locate Bio Announced the In-licencing of Multiple Late Stage Orthobiologics Assets from RCSI University of Medicine and Health Sciences

The technologies developed by the RCSI Tissue Engineering Research Group have extensive pre-clinical and human data demonstrating their effectiveness in the treatment of both hard and soft tissues.

QIAGEN Fully Acquires NeuMoDx Molecular Rounding Out Portfolio of PCR-Based Diagnostic Automation Systems

September 17, 2020 QIAGEN N.V. today announced the acquisition of the remaining 80.1% of diagnostics instruments company NeuMoDx Molecular, Inc. for $248 million in cash....

BioNTech to Acquire GMP Manufacturing Site: To Expand COVID-19 Vaccine Production Capacity in First Half 2021

BioNTech notes the transaction is expected to close in the fourth quarter of 2020. The Company plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021.

Executives

On the Move

Biotech / Diagnostic

Industry Updates

Jack Wang Ph.D. Appointed to Pressao Medical BOD: An Accomplished Business Leader

"I am excited to join Pressao Medical board bringing this innovative technology to market and improving quality of life of patients around the world. The patient benefits are easy to see, and the opportunity for growth is striking," says Jack Wang.

Vox Biomedical Receives NIH Award for Rapid COVID-19 Diagnostic Development

Vox Medical reports the award calls for a biomarker discovery effort to determine the exhaled breath molecular species most suitable for use as a COVID-19 biomarker and methods of capture that can be implemented within the safety paradigm governing COVID-19 testing.

Insilico Medicine Releases Pandomics, AI-powered Platform for Novel Therapeutic Target Discovery

The company started working on an engine for target identification back in 2014. Since then, the technology has been validated through several successful partnering initiatives with pharmaceutical companies and research organizations as well as through Insilico Medicine's own internal drug development programs.

HART KD a Highly Accurate, Artificial Intelligence-driven Blood Test for Kawasaki Disease

The company used their long-standing, certified laboratory partner, Myriad RBM, to conduct protein measurements on blood samples collected from children with Kawasaki disease and is developing commercial options for offering HART KD for children suspected of Kawasaki disease.

Hospitals in the News

Programs, Physicians, Services

Kindred Healthcare and Community Health Network Announce Plans to Build Third Inpatient Rehabilitation Hospital in the Indianapolis Area

This third hospital will be located in the western part of the Indianapolis metro area to help address the growing need for inpatient rehabilitation services in the Indianapolis market.

Compass Health Celebrates Virtual Building Communities of Hope Gala by Honoring Client Stories on World Mental Health Day

Compass Health, President and CEO Tom Sebastian said, “Every year, Compass Health serves 6,300 children and families across Northwest Washington. In 2020 – as families grapple with medical, educational, economic and social challenges – we know that our mental health and substance use support services are more important than ever."

Canopy Children’s Solutions Partners with Baptist Memorial Health Care to “Illuminate Hope” on World Mental Health Day

“We are in a significant mental health moment and it is critical to be resilient and focused on hope so we may maintain the momentum to move forward,” said Canopy Children’s Solutions CEO John D. Damon, Ph.D.

Non Profit

Medical Association News

American College of Cardiology, Novartis Collaborate to Optimize Heart Failure Care

“Heart Failure is the No. 1 diagnosis leading to potentially preventable hospitalizations, especially among the elderly,” said ACC Interim CEO Cathleen Gates. “Advancing quality, equity and value of cardiovascular care is a strategic priority for the College, and programs like this help us to optimize HF patient treatment and care and outcomes.” 

Appropriate Use Criteria (AUC) for the Management of Rotator Cuff Pathology Fact Sheet

The treatment scenarios provided by this AUC stem from the recommendations in the Clinical Practice Guideline (CPG) issued by the AAOS in March 2019.

The Boehringer Ingelheim and Lilly Alliance Supports ACC COVID-19 Response Initiative

ACC’s COVID-19 response initiative offers a virtual education series, resources to meet clinicians’ evolving needs in ensuring patient safety and quality cardiovascular care during the pandemic

Market Reports

Analysis

Global Electronic Medical Record Markets 2020

The market growth of global electronic medical record market has been accelerated due to feasibility in data availability across the globe and growing need of integrated healthcare system. I

$36.7 Billion Worldwide Diabetes Devices Industry to 2027

The global market for Diabetes Devices estimated at US$24.7 Billion in the year 2020, is projected to reach a revised size of US$36.7 Billion by 2027, growing at a CAGR of 5.8% over the period 2020-2027.

Medical Plastics 2020 Global Market Overview

Medical plastics are widely used in medical devices like disposable syringes, intravenous blood bags, optical and dental products, MRIs, heart valves, contact lenses, prosthetic devices, and many more medical products.

September 7 - 11, 2020

Last Week's Popular News!

In-Vitro Diagnostics

"Streck is excited about this milestone for Cell-Free DNA BCT," said Product Manager Joel Lechner. "We have always known that Cell-Free DNA BCT is the best tube for customers who are concerned about pre-analytical variation, but De Novo IVD status solidifies Cell-Free DNA BCT as a truly novel collection tube."

Ultrasound Partnership

QT Ultrasound focused on China for international expansion because China is the second-largest medical device market in the world, following the United States.

TTVR System Update

The LINQ device will alert clinicians if a patient is at high risk for a heart failure event, allowing time for a physician to adjust medications to enhance patient health.