Medical Device News Magazine

Thursday, April 2, 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.

Medical Device News Magazine is monitoring the latest news about COVID-19. That’s why we’re doing all we can to make sure our publication stays open. As a result, our employees are working from home. You can count on us at all times. A response will be returned expeditiously. Thank you.

Bashir® Endovascular Catheter First-In-Human Trial for Acute Pulmonary Embolism Confirms Early Safety and Feasibility and Impressive Reduction of Clot Burden

Thrombolex Reports Data Showed a Significant Reduction in Right Ventricular to Left Ventricular (RV/LV) Diameter Ratio and Clot Burden. Data Presented at the American Venous Forum Annual Meeting

READ

Ventec Life Systems

Ventec Life Systems and GM Partner to Mass Produce Critical Care Ventilators in Response to COVID-19 Pandemic

March 31, 2020

On March 27, 2020, Ventec Life Systems announced that General Motors will build VOCSN critical care ventilators at GM’s Kokomo, Indiana manufacturing facility with FDA-cleared ventilators scheduled to ship as soon as next month.

pDVA Experts Panel Video Discussion: LimbFlow, SA Transforming CLI

Vascular Specialists Dialogue: Dr. Roberto Ferraresi, Dr. Steve Henao and Dr. David Deaton

VIDEO

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

READ

Valve Durability in TAVR is a Critical Factor for the Future

Author: Bart Meuris, M.D., Ph.D. University Leuven Hospital, Belgium Renders His Views

READ

First Patients Treated with the LOBO Vascular Occluder

LOBO Vascular Occluder is designed to provide interventional physicians with a single-device, one-and-done solution for the occlusion of various arterial targets without the need for multiple embolic devices

READ

ASSOCIATION NEWS

Critical Care Surgery Team Develops Surgery Blueprint for Essential Operations During COVID-19

NON PROFITMarch 30, 2020

A systemwide tiered approach to triage the most pressing operations aims to keep hospital resources focused on treating COVID-19 patients

EXECUTIVES

Jay M. Moyes Appointed New CFO of Sera Prognostics

ExecutivesApril 2, 2020

Jay Moyes joins Sera Prognostics as it transitions from rigorous scientific and groundbreaking clinical stage company into a rapidly growing commercial organization.

HOSPITALS IN THE NEWS

Datos COVID-19 Solution Employed at Rochester Regional Health

Hospitals in the NewsApril 1, 2020

The partnership is enabling Rochester Regional Health to more efficiently and safely monitor patients and healthcare workers exposed to or suffering from coronavirus, outside of the hospital setting.

US FOOD & DRUG ADMINISTRATION UPDATES

Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19

FDA1March 31, 2020

As part of the Trump Administration's all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency's disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.

BREAKING MEDICAL DEVICE INDUSTRY NEWS

Tablo® Hemodialysis System Receives FDA Clearance for Home Dialysis

April 2, 2020

The Food and Drug Administration cleared the Tablo Hemodialysis System for patient use in the home. The new home clearance expands Tablo's existing labeled indication for use in acute and chronic care facilities, which for the first time enables healthcare providers the same dialysis machine from the ICU to the home.

Signatera™ Technology for Personalized Monitoring in Gastrointestinal Cancer Shows Benefits According to a New Study

April 2, 2020

A new, peer-reviewed case study published in JCO Precision Oncology1 demonstrates the unique ability of Signatera technology to detect esophageal cancer recurrence almost one year before current standards of care, using a simple blood draw to monitor for traces of circulating tumor DNA (ctDNA). This report builds upon a fast-growing body of scientific evidence behind the Signatera test across multiple cancer types.

AMRA Medical and Fulcrum Therapeutics Develop MRI Method for Multi-site Neuromuscular Clinical Trials

April 2, 2020

In collaboration, AMRA Medical and Fulcrum Therapeutics created a standardized whole-body magnetic resonance imaging (MRI) protocol to evaluate skeletal muscle composition in patients with facioscapulohumeral dystrophy (FSHD) – a slowly progressing muscular dystrophy. An abstract describing this work was accepted and made publicly available by the Muscular Dystrophy Association.

Sectra Digital Pathology Module Receives FDA Clearance

April 1, 2020

The clearance applies for Sectra Digital Pathology Module, the key component of Sectra's pathology solution, when used together with Leica Biosystems' scanner AT2 DX. This enables US healthcare providers to use Sectra's digital pathology solution for primary diagnostics. The solution makes it possible to move towards fully integrated diagnostics, which is especially important in complex cancer cases.

COVID Care’s COVID-19 IgG and IgM Rapid Test Now uthorized Pursuant to FDA EUA Guidance

April 1, 2020

The FDA Approved Rapid COVID-19 Test Kits for Medical Professionals, First Responders, and Law Enforcement detects IgG and IgM antibodies to SARS-CoV-2 in human blood. The Covid Care Rapid Test has a 91% Clinical Sensitivity rating, and a 99% Clinical Specifity rating.

Synchrocyclotron for the MEVION S250i Proton Therapy System Delivered to Huntsman Cancer Institute

April 1, 2020

The proton center at Huntsman Cancer Institute at the University of Utah will be the first in the Mountain West.

Henry Schein Announces Further Efforts to Address the COVID-19 Pandemic

April 1, 2020

The company announced today that it will serve as the exclusive distributor in the United States of a second point-of-care rapid test kit that can detect antibodies associated with COVID-19 in as few as 15 minutes.

GEP Introduces a Free Portal & Service to Connect Health Care Providers: Beginning with Hospitals in New York, New Jersey & Connecticut with PPE Suppliers

March 31, 2020

The portal will help connect PPE suppliers and manufacturers with frontline health care providers.

Superfeet to Produce 30,000 Respirator Masks for Local Healthcare Workers and Hospitals

March 31, 2020

A week after a national announcement opening their doors to help those needing access to personal protective equipment (PPE) to combat the COVID-19 pandemic, Superfeet and sister company Flowbuilt Manufacturing has started production of PPE masks with 3D-printed elements.

enlightenVue™ Reports Single-Use Micro Endoscope Receives FDA 510(k) Clearance

March 31, 2020

The novel single-use micro-endoscope with multiple working channels eliminates the risk of transmitting infections between patients.

Reprocessing N95 Masks With STERRAD: Protects Healthcare Workers in the Battle Against COVID-19

March 30, 2020

The evolution of the COVID-19 pandemic has created a mass shortage of N95 masks for healthcare professionals around the world. ASP qualified a protocol for reprocessing select N95 masks so hospitals can triple the lifespan of the mask using the STERRAD® Sterilizers already in healthcare facilities today to reprocess up to 480 masks per STERRAD® Sterilizer machine daily to help healthcare professionals combat the spread of coronavirus.

FDA Approves Next-Generation ZOLL® TherOx System for Widowmaker Heart Attack Patients

March 30, 2020

The second-generation TherOx System provides SuperSaturated Oxygen (SSO2) Therapy and reduces heart muscle damage in “widowmaker” heart attack patients.

Fractyl Announces New REVITA-2 Study Clinical Data

March 30, 2020

Data presented at ENDO 2020 from the randomized, sham-controlled REVITA-2 study verifies that improvements in blood glucose control (HbA1C), insulin sensitivity, and other metabolic measures seen after one Revita treatment are also associated with improved pancreatic beta-cell function

INVU Remote Pregnancy Monitoring System Receives FDA Clearance

March 30, 2020

INVU™ is a prescription-initiated, protocol-driven remote monitoring platform that offers measurements of fetal and maternal heart rate via a wireless, self-administered INVU sensor band.

National Ventilator Registry Launched by Phunware

March 27, 2020

“We have built a data engine that is capable of managing over a billion active devices and four billion daily transactions while generating more than 5 terabytes of data each day,” said Randall Crowder, COO of Phunware.

New Non-Contact Forehead Infrared Thermometer to Aid in Coronavirus Prevention

March 27, 2020

DeltaTrak reports the new Model 15004 Non-Contact Forehead Infrared Thermometer serves as a valuable solution in the fight against the Coronavirus.

GEN2 Pure-Vu System Receives CE Mark Approval

March 27, 2020

Motus GI is assessing potential strategic partnership opportunities for the Pure-Vu System with established medical device companies and distributors with commercial operations across the EU.

Barco® Uniforms Launches COVID-19 Scrub Donation Program

March 27, 2020

Barco pledges to donate 10,000 scrubs each month for the duration of the coronavirus pandemic to healthcare professionals on the front line treating patients who have been infected.

Orthofix Completes Acquisition of FITBONE Limb Lengthening System

March 26, 2020

The transaction also includes other potential applications of the technology which are in development, including the FITSPINE® system for fusionless surgery to treat early-onset scoliosis.

ShiraTronics, Inc. Completes $3 Million Additional Series A Financing

March 26, 2020

Financing was provided by Breakout Ventures (BOV). BOV joins previous Series A lead investors USVP, Amzak Health, and Strategic HealthCare Investment Partners (S.H.I.P), with participation from Aperture Ventures, LivaNova PLC, and a leading Academic Institution.

Enrollment in Tria LifePolymer™ Early Feasibility Study Completed

March 25, 2020

Fifteen patients have been enrolled in the Tria LifePolymer early feasibility study reports FOLDAX.

Team in Toronto and Winnipeg to Begin Production of Medical Scrubs and Patient Gowns

March 25, 2020

Canada Goose will leverage its manufacturing facilities to begin production of necessary medical gear for frontline healthcare workers and patients across Canada in the fight against COVID-19.

ixlayer COVID-19 Clinical Test Platform to Power Labs and Health Systems Launched

March 25, 2020

The ixlayer COVID-19 Clinical Test can plug into any health system and lab within 48 hours - enabling labs to digitize ordering and produce real-time results delivery while also streamlining healthcare so physicians can pre-screen patients, order tests, coordinate sample collection and triage patients to the right care ... all from afar

KN95 Disposable Masks Now Available on Avenova.com

March 25, 2020

The KN95 masks are being sold at a price of $59.99 for a package containing 10 masks or $149.99 for a package containing 30 masks. KN95-rated masks are effective at filtering out at least 95% of airborne particles, including microorganisms, dust, pollen and air pollution.

University of Helsinki and IRRAS Will Collaborate to Advance Uses of IRRAflow

March 25, 2020

The initial area of focus will be in the treatment of patients suffering from intraventricular hemorrhage (IVH).

SonoScape Shares its Experience of Fighting Against COVID-19 to the Global Community

March 25, 2020

SonoScape headquartered in Shenzhen China, started to help with the coronavirus epidemic as early as in January.

Telehealth Virtual Visits Software is Launched by Seattle Based MedBridge

March 25, 2020

MedBridge reports the software will help clients virtually manage patient care throughout the COVID-19 crisis.

NxGen MDx Announces Immediate Launch of COVID-19 Test

March 23, 2020

The rise in U.S. cases of COVID-19, a highly contagious and sometimes fatal respiratory illness, has concerned health officials and spurred calls from lawmakers for action to expand testing capacity to slow its spread.

Lipiodol® Ultra Fluid for Hysterosalpingography in Women Undergoing Infertility Workup

March 23, 2020

Guerbet has received indication approval in Hungary and the Netherlands where Lipiodol® Ultra Fluid is now indicated for hysterosalpingography (HSG) in women undergoing infertility workup. Hungary and the Netherlands are the second and third European countries to grant approval for this indication after Ireland.

Senseonics Exploring Strategic Options to Enhance Stakeholder Value

March 23, 2020

Board of Directors has decided to explore potential strategic alternatives to enhance stakeholder value. The Company is engaging Moelis & Company, LLC as its financial advisor and Cooley, LLP as its legal advisor.

RedHawk Appoints Florida Based Dolphin Medical as Exclusive SANDD™ Distributor for Five Gulf Coast States

March 23, 2020

Under the Agreement, Dolphin has committed, among other things, to purchase annually from RedHawk for resale in the Territories, 6,000 SANDD mini™, SANDD HP™ or SANDD FR™ needle incineration devices, 2,000 SANDD Pro™ needle incineration devices and certain other medical supplies. The Agreement provides that RedHawk will sell the SANDD™ devices to Dolphin at list price less a customary distributor discount. Certain volume discounts are also available to Dolphin.

Wearable Medical Tech Ushers in a New Era for Patients

March 23, 2020

Wearable medical devices are designed to measure various metrics on the human body without doctor intervention. The most commonly measured data include vital signs such as heart rate, blood pressure, blood oxygen saturation, blood glucose levels as well as physical activities through the use of electrocardiogram (ECG), ballistocardiogram (BCG) and other devices

Aseptico Announces Availability of Products Suitable for Medical and Civic use for Coronavirus Pandemic

March 23, 2020

Several of its field dentistry and other products are suitable and available for sale to medical health professionals and other public entities fighting the coronavirus (COVID-19) pandemic.