Medical Device News Magazine

Thursday, February 27, 2020

Welcome! Medical Device News Magazine reports the latest medical device industry news, clinical trials and updates, product launches, FDA announcements, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Medical Device News Magazine distributes industry news to medical specialists, medical device industry executives, investors and other allied health professionals. This is accomplished utilizing various social media outlets and targeted subscriber email blasts. We invite you to visit us daily and consider advertising.

Dlyte as a Disruptive Solution for Surface Finishing in Healthcare Applications

Author: Jaume Miras, Chief Strategy Officer GPAINNOVA Barcelona, Spain Addresses Implant Limitations and More


Surgeons Find the Best Preoperative Definition of Cancer-Related Malnutrition Depends on Cancer Type

The best approach for surgeons to identify malnourished cancer patients before they have a cancer operation may be specifically related to the type of cancer the patient has, according to researchers who found that common definitions of malnutrition do not apply equally to all cancers in assessment of preoperative risk. The study is published as an “article in press” on the Journal of the American College of Surgeons website ahead of print.


Daniel Florin Joins Pulmonix Board of Directors

Daniel Florin has been serving as Executive Vice President at Zimmer Biomet Holdings Inc. since July 2019.


Medical Electronics Worldwide Market is Projected to Grow by US $1.6 Billion

Representing the developed world, the United States will maintain a 6.5% growth momentum.


PROCEPT BioRobotics Announces Three-Year Follow-Up Data Confirming Sustained Efficacy, Superior Safety of Aquablation® Therapy for Benign Prostatic Hyperplasia

The three-year follow-up data from the blinded, randomized WATER clinical study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) has confirmed the efficacy, safety, and durability of Aquablation therapy for the treatment of benign prostatic hyperplasia (BPH). The data, published in the Canadian Journal of Urology, compared Aquablation therapy, delivered by the AquaBeam® Robotic System, with transurethral resection of the prostate (TURP). This publication not only builds upon the increasing evidence for Aquablation therapy, but also confirms that Aquablation therapy provides both durable symptom relief and a sustained safety advantage compared to TURP.

Masimo and MS Westfalia GmbH (MSW) Expand Partnership to Add Masimo SedLine® Brain Function Monitoring, O3® Regional Oximetry, and Oxygen Reserve Index (ORi™) to the MSW Modular Point-of-Care Hybrid...

MSW will integrate additional Masimo measurement technologies into MSW’s plug-and-play hybrid Jenny platform, to help clinicians assess brain function, oxygenation, ventilation, and resuscitation status.

Spaulding Clinical Research Awarded Five-Year Contract With FDA Division of Applied Regulatory Science

Will conduct multiple clinical trials in various therapeutic areas of interest. They have kicked off this agreement with $5 million of clinical trial work to be run in 2020. Spaulding Clinical is responsible for conducting the trials and providing the necessary support services including clinical trial recruitment, conduct, and laboratory assessments.

Peri-Strips Dry With Secure Grip Technology for Reliable Staple Line Reinforcement in Surgical Procedures Launched

Now available with “peel and secure” technology, PSDV is a staple line reinforcement material that bariatric surgeons have used to mitigate staple line complications for more than 15 years. This new generation of PSDV is two times faster to prepare compared to the previous version and another staple line reinforcement product.

Ibex Obtains CE-IVD Mark for Galen™ Prostate Solution

With this CE-IVD Mark of Galen Prostate, Ibex is now partnering with leading institutes across Europe to implement AI and support pathologists in their diagnostic workflow.  

First Patient Enrolled in Pivotal Atherectomy Clinical Study

To evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses.

Gore Innovation Center Announces Collaboration With Robotics Startup Moray Medical

The Gore Innovation Center today announced a collaboration with Moray Medical, a 2-year-old startup developing precision automated delivery systems for endovascular procedures. The Gore Innovation Center collaboration with Moray Medical is aimed at fundamentally improving the control and accuracy of minimally invasive interventional medical procedures.

Launch of VITROS® XT 3400 Chemistry System from Ortho Clinical Diagnostics

VITROS XT Solutions, which include the new VITROS XT 3400 Chemistry System and the VITROS® XT 7600 Integrated System with new XT MicroSlides, help ensure the right result the first time, expediting critical health information to clinicians who can make decisions faster and ultimately improve patient outcomes.

Adaptas Solutions to Acquire Applied Kilovolts and Analytical Instrumentation Business from L3Harris Technologies

Adaptas Solutions, LLC. and L3Harris Technologies have signed a definitive agreement for Adaptas to acquire L3Harris' Applied Kilovolts and Analytical Instrumentation business.

Coronavirus: Novavax Advances Development of Novel COVID-19 Vaccine

The company announced progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of spring 2020.

Wave Neuroscience Acquires Assets of NeoSync

NeoSync is a pioneer in personalized, low-energy brain stimulation for the treatment of Major Depressive Disorder and other diseases of the Central Nervous System (CNS).

FDA Approves to Continue the PROMISE Sensor Clinical Study in an Extended Cohort to 365 Days to Gather Feasibility Data

PROMISE Sensor Clinical Study is to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over a 180-day period for the pre-market application submission to the U.S.

Carillon® System Shows Favorable Long-Term Survival Rate In Patients With Functional Mitral Regurgitation

Data was presented in a late-breaking trial session at the Cardiovascular Research Technologies meeting (CRT 2020) in National Harbor, MD.

ClinOne Offers Complimentary Support to Researchers Racing to Develop the Coronavirus or COVID-19 Vaccine

In December 2019, cases of Influenza, primarily Influenza A and Influenza B, were climbing dramatically within the United States. Globally, Influenza A was in full force, with symptoms including cough, fever, chills, sore throat, nasal congestion, headache, and fatigue. At that very moment, a cluster of people diagnosed with pneumonia of unknown etiology was identified by the Chinese health authority.

Zynex Receives FDA Clearance for its Blood Volume Monitor

Blood Volume Monitor is fully developed, has performed well in multiple clinical trials and can guide medical professionals in hospitals and surgical centers towards better fluid management during surgery and in recovery settings.

Novalung® for Treatment of Acute Respiratory and Cardiopulmonary Failure Receives FDA Clearance

Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support.

Promega Launches Wizard® HMW DNA Extraction Kit Ahead of 2020

The Wizard® HMW DNA Extraction Kit was demonstrated in a poster presented at the AGBT meeting.

Luminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance

Luminex Corporation today announced they submitted an application to the FDA for 510(k) clearance of the VERIGENE® II Respiratory Flex Assay, the second VERIGENE II assay to be submitted to the agency. The VERIGENE® II Respiratory Flex (RSP Flex) Assay is a multiplexed, qualitative test for simultaneous detection and identification of common viruses and bacteria from nasopharyngeal swabs that are obtained from individuals suspected of respiratory tract infection.

WaveGuide Corporation Launches World’s First Portable NMR Device

The WaveGuide Formla™ micro NMR delivers performance as good or better than larger, more costly benchtop NMRs, in a portable, easy-to-use device.

Study Published in Journal of Pediatrics Uses Advanced Imaging Techniques to Optimize a Leading-Edge Therapy for babies with oxygen deprivation

Published this week, the study provides the foundation clinicians need to personalize this therapy in the future. In order to optimize this neuroprotective technique, the investigators need to understand precisely how therapeutic hypothermia affects a baby’s brain temperature.

Peregrine Post-Market Study Published in the Journal of the American College of Cardiology: Cardiovascular Interventions

Peregrine Post-Market Study is a European multicenter open-label trial that evaluated additional safety and performance of the Peregrine System Infusion Catheter using a neurolytic agent (dehydrated alcohol) delivered into the space outside of the renal (kidney) arteries in 45 patients with systemic hypertension.

Genesys Spine Launches Sacroiliac Joint Fusion System

Genesys Spine Sacroiliac Joint Fusion System consists of partially threaded and fully threaded implants designed to secure the sacroiliac joint and minimize micro-motion enabling bony fusion.

New MolecuLight i:X® Upgrade Enables Faster, More Accurate Digital Wound Measurement

Specifically, clinicians can now reliably detect more complex wound borders using the i:X's Auto Mode feature and can also now input a depth measurement.

‘Transformative’ Surgical Robot Versius® Begins First NHS Procedures

Versius® has been used to successfully perform minimal access surgery (MAS) on patients within the NHS.

ICON Acquires MedPass International

This acquisition, concluded in late January, further enhances ICON’s Medical Device and Diagnostic Research Services, through the addition of new regulatory and clinical capabilities in Europe.

Canon Medical Receives FDA Clearance for Aquilion ONE / PRISM Edition, Enabling Deep Learning Spectral Capabilities for Routine Use

Designed for deep intelligence, the advanced system integrates artificial intelligence (AI) technology to maximize conventional and spectral CT capabilities with automated workflows, while providing deep clinical insights to assist physicians in making more informed decisions across the patient’s care cycle.

Leo Lens Pharma Strengthens its Pipeline with New IP Protection for a Unique Atropine-based Myopia Management Solution

The novel product will allow patients suffering from, or at a high risk of developing, myopia to wear a contact lens that can automatically and continuously deliver a drug to control myopia, such as low dose Atropine, to the patient’s eye.

Flowonix Receives FDA Approval to Market Prometra® II Pump

The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of drug therapy, including Infumorph® (preservative-free morphine sulfate sterile solution), preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP), and baclofen (baclofen injection, intrathecal, 500-2000 mcg/mL).

Large Clinical Study to Support Underway Reports Diabeloop

Note: In December 2019, the company completed a record-breaking Series B funding round of 31 million euros intended to support its launch strategy in major international markets (particularly in Europe and the United States).

Publication of COMPASS Study Validating First Scoring Guidelines for WatchPAT™ Device in Diagnosing Sleep Apnea

The study appears online in the Journal of Clinical Sleep Medicine.

Published Real-World Experience Demonstrates VasQ™ External Support Improves Outcomes When Adopted as the Standard of Care

The paper demonstrated that using VasQ as the standard of care for radiocephalic fistulas resulted in a significant improvement in his center’s primary fistula failure and longer-term secondary patency rates with less repeat interventions when compared to historical controls.

Cerus Endovascular Receives CE Mark Approval for its Contour Neurovascular System™

CE Mark approval was based on data generated from the company's two EU studies evaluating the safety and efficacy of the Contour Neurovascular System™, focusing on unruptured intracranial aneurysms.

Next-Generation Heart Rhythm Management Devices in Europe, Featuring State-of-the-Art Patient App and Bluetooth Connectivity

Abbot reports the devices offer new opportunities for patient engagement and remote monitoring through new smartphone connectivity and connected applications. Additional benefits include a patient preferred design, improved battery longevity, and MRI compatibility.

Perry Baromedical Acquires Hyperbaric Division of ETC

This business unit acquisition advances Perry Baromedical into new international markets and expands the installed base in the US and abroad. 

Acutus Medical Secures FDA Clearance and CE Mark for SuperMap™

SuperMap is a high-fidelity, high-resolution mapping algorithm for both stable and transient arrhythmias.

Update on FDA 510(k) Submission for the CellFX System in Dermatology: Reported by Pulse Biosciences

We remain highly confident in the CellFX System and its safety and efficacy profile in aesthetic dermatology. We look forward to continuing to work with FDA to obtain a clearance for the CellFX system in dermatology.” said Darrin Uecker, President and CEO of Pulse Biosciences.

ECG Patch Added to the Caretaker® Wireless Patient Monitoring Platform

Both the Caretaker wireless monitor and the VivaLNK ECG Patch are FDA-Cleared and CE-Mark certified and available for purchase from Caretaker Medical and its distributors. 

Breakthrough Study Published Measuring the Effect of EOTTS to Reduce Medial Knee Compartment Forces

The research from this study confirmed that ankle bone displacement leads to increased forces on the inner knee, the most common area of knee joint arthritis. The insertion of the HyProCure® titanium spacer/stent reduced the pressure by nearly 33%. This is the very first treatment that has shown this kind of reduction of pressure.

Orthofix Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators

The STIM onTrack technology works with the Orthofix Bone Growth Therapy devices. The mobile device app is an accessory designed to help patients adhere to their prescriptions and improve their clinical outcomes.

In2Bones Announces U.S. Launch of the Avenger Radial Head™ Prosthesis With Sterile, Single-Use Instruments

The new prosthesis restores elbow joint function and provides several advantages to surgeons and patients compared with current prosthetic systems. It is the first radial head implant to include sterile, single-use instrumentation.

Metactive Medical Announces Name Change to Artio Medical

Artio Medical was founded in 2014 as a small R&D group focused on developing metal implants for vascular embolization.

Medtronic Acquires Digital Surgery

The acquisition of Digital Surgery will strengthen the Medtronic robotic-assisted surgery platform and has applicability for the Medtronic broader portfolio. The terms of the agreement are not being disclosed.

Carevive Systems Raises New Financing Round with Philips and Debiopharm

Company reports the new funding round will strengthen position as the market leader in understanding and improving the cancer patient experience.

Foster Corp. Enters into Partnership with LioChem to Expand Medical Color Masterbatch Capability

LioChem’s expertise will serve to augment, and expand, Foster’s current capability in supply of medical color masterbatch by offering larger volume capability as well as providing expertise in critical color matching situations with excellent color match turn-around service levels.

Precision OS Trains More Than 300 Medical Device Representatives in 30 Minutes Using Virtual Reality

The the event brought together more than 300 medical device representatives who simultaneously accessed the training module on a complex surgical procedure.

RedHawk Holdings Partners With Sales Organization to Market SANDD™ Needle Incineration Devices

With 8 marketing representatives located in New York, New Jersey, Connecticut, Massachusetts, Florida and Utah, CKRX markets a variety of value savings programs to hospitals, physicians, pharmacies and clinics including a free point of sale discount on both brand and generic prescriptions to an estimated 75,000 pharmacies.

Neurovision Medical Products Receives Second Patent for Detection of Reversible Nerve Injury

Neurovision Medical Products reports the intuitive surgical tool provides a real-time indication of the relative health and integrity of the nerve.

BD Completes Clinical Trial for BD Libertas™ Wearable Injector Completed

The award-winning injector* is a subcutaneous drug delivery system, currently in development, that is designed to require no patient assembly and deliver biologics with viscosities up to 50 cP in 2-5 mL and 5-10 mL configurations.

FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System

The company reports that the Surfacer System will be available in select U.S. centers in the coming months. The system received CE Mark in 2016 and is available in Europe, Canada, Singapore and the Middle East.

Soliton Files Special 510(k) with FDA for its Generation II RAP Acoustic Pulse Device

The Generation II RAP device delivers the same tattoo-removal therapy as the Generation I device, but is slightly modified for improved ease of use in the physician's office.

Bioventus Updates Indications for Use of Their EXOGEN Ultrasound Bone Healing System

EXOGEN uses process and promote fracture healing. It has an 86% heal rate for fractures not healing on their own1 and provides 38% faster healing of indicated fresh fractures.

DynaNail Mini® Fusion System for Subtalar Fusion Procedures Shows Positive Early Results

The DynaNail Mini® Fusion System has been implanted by over 50 orthopedic surgeons in over 50 hospitals across the United States.

BrainsWay Announces Data from Feasibility Study of Deep Transcranial Magnetic Stimulation System

Results showed a statistically significant improvement in patient-reported assessments of inattention, together with a significant increase in activity that was observed within the dorsolateral prefrontal cortex (DLPFC), a brain area previously shown to express reduced activity in adults with ADHD.

CorMatrix® Cardiovascular, Inc. Receives FDA Approval to Expand and Enroll 20 Additional Patients in the Adult Arm of its Early Feasibility  IDE study of the Cor® TRICUSPID ECM® Valve...

The Cor® TRICUSPID ECM® valve has been successfully implanted in the 11th patient enrolled in the expansion by Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Heart Center in Indianapolis, Indiana & principal investigator for the adult component of the study.

Onkos Surgical® Launches GenVie™

GenVie™ is the first 510(k) cleared magnesium-based bone void filler in the orthopedic marketplace and is available via a private label distribution agreement with Bone Solutions Inc. (OsteoCrete®) announced in late 2019.

Aroa Biosurgery Launches Large Format Endoform®

Aroa Biosurgery reports their wound care products, the 8.5 by 6-inch device has been launched in the US and Canadian markets, following its recent approval for reimbursement within the U.S. healthcare system.

Nanox Signs Strategic Collaboration Agreement With USARAD

As part of the agreement, USARAD will utilize existing radiologists and recruit additional professionals to become service providers using the Nanox.ARC and the Nanox.CLOUD for imaging diagnostics.

SMART Medical Systems Launches its G-EYE® 760R Colonoscope in the European Endoscopy Market Through FUJIFILM Europe

SMART's G-EYE® 760R colonoscope, incorporating its G-EYE® Balloon Technology designed to increase the detection of cancerous polyps in colonoscopy, will become available by FUJIFILM Europe with its state-of-the-art ELUXEO system, as part of the newly formed strategic distribution partnership with FUJIFILM Corporation.

Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®

This approval represents a major milestone that will be a key value driver for Atlantic Therapeutics.