Wednesday, January 22, 2020
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Breaking Medical Device Industry News
Wednesday, January 22, 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.

What You Should Ask About Intellectual Property Before Investing: An IP Due Diligence Primer

Guest Editorial: Rod S. Berman, Greg S. Cordrey, and Jessica Bromall Sparkman of Jeffer Mangels Butler & Mitchell LLP
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Interview with Dr. Dov Rubin, CEO of Lev-El Diagnostics on HeartTrends

Dr. Dov Rubin, CEO of Lev-El Diagnostics talks about how HeartTrends can be used in the early detection of myocardial ischemia, how it differs from traditional stress testing and more.
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ASSOCIATION NEWS

Society for Vascular Surgery Patient Safety Organization, and the Society for Vascular Medicine, with Support from the American Heart Association, Launch New Vascular Medicine Consult Registry for the Vascular...

NON PROFIT
The Registry targets the management of new patients who are being treated medically for Atherosclerotic Carotid Artery Occlusive Disease, Abdominal Aortic Aneurysm, and Peripheral Lower Extremity Arterial Disease due to atherosclerosis or true aneurysm.
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EXECUTIVES ON THE MOVE

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MARKET REPORTS

Global Bronchoscopy Market Expected to Grow with a CAGR of 5.9% During the Forecast Period, 2019-2024

Market Analysis
The key factors driving the growth of this market include the growing demand for minimally invasive surgery, growing hospital investments in bronchoscopy facilities, and technological advancements in bronchoscopy.
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Flow Cytometry Market

Market Analysis
The Flow Cytometry Market is projected to reach USD 6.4 billion by 2025 from USD 4.0 billion in 2019, at a CAGR of 8.3%.
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BREAKING MEDICAL DEVICE INDUSTRY NEWS

Brainlab Acquires VisionTree to Drive Patient-Reported Outcomes

Medical technology company emphasizes commitment to value-based healthcare by combining electronic patient-reported outcomes (ePRO) with registries, treatment planning and image data generated by its software tools
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FDA Approves Micra™ AV Reports Medtronic

Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired.
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Vesalius Cardiovascular Announces the Completion of a Successful Chronic Animal Study

The predetermined endpoints of the study were the absence of device or valve thrombosis and the absence of leaflet injury due to the device, and both endpoints were robustly confirmed upon completion of the study.
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AIROS 8 Sequential Compression Therapy Device Granted FDA 510(k) Clearance

The AIROS 8 Sequential Compression Therapy device uses pneumatic air compression to inflate accessory garments worn on the affected area of the body.
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First Study of Thoraguard Digital Drainage System Completed

Thoraguard is the first surgical drainage device to provide automated clog clearance without requiring human intervention, and digitally measures and displays hourly drainage volume and trends to facilitate clinical decision-making after cardiac surgery.
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Ra Medical Systems Receives FDA IDE Approval to Begin Pivotal Atherectomy Clinical Study

Ra Medical Systems
In May 2017, DABRA received FDA 510(k) clearance for use in ablating a channel in occlusive peripheral vascular disease (PAD).
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Algentech Granted US Patent For A Key Genome Editing Technology

ALGENTECH
Algentech's invention optimizes the cellular process known as homologous recombination. In order to precisely insert or modify a genetic sequence, existing technologies use nucleases that introduce specific breaks in the target DNA and then rely on the cellular machinery to complete the editing process.
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3M Shares NICE Medtech Innovation Briefing

3M
Clinical studies in NICE’s evidence review demonstrated that V.A.C. VERAFLO™ Therapy is more effective than standard of care, in acutely infected or chronic non-healing wounds.
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FEops Reports PREDICT-LAA Trial Enrolls First Patient

FEops
FEops reports the trial is led by Righshospitalet, Copenhagen, Denmark.
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Advanced ICU Care Launches Tele-ICU Services at Regional Medical Center

Advanced ICU Care
Advanced ICU Care states the tele-ICU care will support patients in the hospital's Intensive Care Unit and Coronary Care Unit.
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IMAGINA Endoscopy System Receives FDA Approval and Launches in the USA

PENTAX Medical
In addition, IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.
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Emendo Biotherapeutics Raises $61 Million

Emendo Biotherapeutics
The financing provides a strong foundation from which we can accelerate our proprietary OMNI gene-editing platform towards a broad clinical pipeline for addressing devastating untreatable diseases.
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Invicro and Paige Announce Strategic Partnership

Invicro LLC
With this strategic alliance, Invicro can now represent Paige’s digital diagnostic and biomarker solutions in the global pharma services market.
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HEDY Group of Guangzhou, China Acquires 10 Elekta Cancer Treatment Systems

Elekta
Anming Gong, Elekta's Executive Vice President Region China, says the company is addressing the country's need for radiation therapy devices and personnel to operate them.
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National Cancer Center Japan Launches Multi-Center Randomized Trial Using Signatera™ MRD Testing in Stage II-III Colorectal Cancer

Natera Inc.
The trial is organized by the NCC and national in scope, and it is expected to include approximately 1500 patients from over 100 cancer centers across Japan.
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Healthy.io Launches a Digital Wound Management Solution

Healthy.io
The solution is an extension of Healthy.io's clinical-grade color recognition products in use by tens of thousands of people worldwide and helps healthcare professionals objectively assess chronic wounds and track their progress over time through a repeatable process. The solution was successfully registered with the U.S. Food and Drug Administration (FDA) in December 2019.
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FDA Approves Micra™ AV Reports Medtronic

Medtronic
Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired.
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Phagenyx® System Receives FDA Approval

Phagenesis Ltd.
FDA's Breakthrough Device Designation Program allows for priority review of the Phagenyx® System.
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MedRhythms Advances Pipeline of Neurologic Rehabilitation Products in Multiple Sclerosis, Parkinson’s Disease

MedRhythms
MedRhythms, a prescription digital therapeutics company, assembles Scientific Advisory Boards for multiple sclerosis and Parkinson's disease with world-leading researchers, and a study of the Company's multiple sclerosis pipeline product (MR-004) to be launched.
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Peer-reviewed Article Reveals a New Spinal Surgery Technique

Carevature Medical Inc.
Carevature Medical's Dreal® technology has assisted surgeons in over 1,500 cases, both non-fusion and fusion.
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FDA Clears Aidoc’s Complete AI Stroke Package

Aidoc
Fourth FDA clearance makes Aidoc the comprehensive solution for radiology AI.
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Mahana Therapeutics Enters Into Licensing Agreement With King’s College London for Innovative Digital Therapeutic to Treat Gastrointestinal Condition

Mahana Therapeutics
The Company has entered into a licensing and collaboration agreement with King’s College London, a leading research university and one of the oldest and most prestigious universities in England.
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Itamar Medical Selected to Participate in the Prestigious Weizmann Institute Project 10K

Itamar Medical Ltd.
WatchPAT has been selected for inclusion in the Weizmann Institute’s Project 10K. 
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Colospan Announces FDA Approval of IDE for Intraluminal Bypass Device

Colospan
With this IDE approval in hand, the company will launch its pivotal study for CG-100, a temporary Intraluminal Bypass Device, designed to reduce diverting stoma rates in patients undergoing gastrointestinal resection procedures.
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US Patent Issued to REVIAN® Duel Band LED Light Therapy

REVIAN
“This is a groundbreaking approach to the therapeutic use of light,” said Dr. Nathan Stasko, co-inventor and Executive Chairman REVIAN Inc. “We set out to decode the spectrum of light and identify which wavelengths encourage cells, tissues and organs to repair themselves.”
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Emmes Announces FDA Approved a Prescription-Only Device Used to Estimate the Weight of Infants Who Are Up to 90 days of Age

Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments.
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FreMon Scientific Announces FDA Clearance of ZipThaw™

ZipThaw, used with the ZipSleeve™ anti-contaminant disposable barrier, is the world's first dry and portable precision plasma thawing system. Clinicians can now deliver vital plasma to patients at the right time and temperature.
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Pulpdent Launches ACTIVA Presto in United States

The new dental filling material mimics the properties of natural teeth.
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Dicerna™ Announces Closing of Agreement With Novo Nordisk

As previously announced on Nov. 18, 2019, Dicerna and Novo Nordisk entered into an agreement to discover and develop novel therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s proprietary GalXC™ RNAi platform technology.
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Terason Partners with AmCad BioMed

Terason reports the partnership addresses a strong market need for more efficient solutions that help physicians evaluate the risk of OSA, a disorder that affects over 425 million people worldwide.
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Velano Secures Additional Funding

Velano Vascular
Latest funding caps year of groundbreaking milestones for transformative vascular access company; new capital will be used to meet rapidly growing hospital and patient demand.
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Anatomage Revives Heart Beat of a Cadaver

Anatomage Inc.
Anatomage develops digital cadavers, which are available on the Anatomage Table. These cadavers are accurately reconstructed from preserved human bodies and serve as precise references for anatomical studies.
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RAPID AI Enhanced Advanced Medical Imaging for Stroke

The RAPID artificial intelligence framework helps to quantify brain lesions and extend the window of potential stroke intervention from six hours after onset to up to 24 hours, for patients with salvageable brain tissue. RAPID provides physicians with fast, fully automated, and easy-to-interpret imaging that facilitates clinical decision-making around stroke.
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Tekni-Plex Forms Tekni-Plex Medical Business Unit

The business unit, which will facilitate the supply of mission-critical, high-value components, materials, and solutions to medical device manufacturers worldwide.
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Prasco Launches the Authorized Generic of NuvaRing® in the USA

Etonogestrel/Ethinyl Estradiol Vaginal Ring is a small, flexible vaginal ring used by women to prevent pregnancy.
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Sofregen Medical Raises $8 Million in Series B Funding Round

The company is developing an advanced platform of products based on silk protein - also known as fibroin - that has been shown to have unique properties for tissue support and regeneration.
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ChromaCode Raises $28 Million in Series C Financing

The round was led by Northpond Ventures, a global firm dedicated to science and technology headquartered in Bethesda, Maryland.
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PureTech Health Affiliate Gelesis Announces Partnership with Ro to Support US Commercialization of Plenity TM

In addition to collaborating with traditional healthcare providers, Gelesis will leverage Ro’s nationwide telehealth services to make Plenity available to patients who don’t have an established healthcare provider or prefer a remote interaction.
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Peripheral Orbital Atherectomy System With GlideAssist® Introduced in Europe

The 1.25 Micro Crown is designed with flexibility for tortuous vessels and tight bends below the knee.
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VolitionRx Limited Reaches Agreement to Acquire Octamer GmbH

The aggregate purchase price is €650,000 Euros (approximately $725,000), consisting of €350,000 cash and approximately 73,000 shares of common stock of Volition, for 100% of the outstanding shares of Octamer.
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World’s First Single-Use Duodenoscope, EXALT™ Model D Receives FDA Clearance

The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device.
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Innovatus Imaging Engineers New Repair Solutions for the Philips X5-1

Expands testing and repair capabilities.
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Primary Endpoint Achieved in Randomized, Controlled Trial of Digital Therapeutic AKL-T03 in Major Depressive Disorder

Results of the study were presented yesterday at the 58th Annual Meeting of the American College of Neuropsychopharmacology.
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Nihon Kohden Launches Life Scope® SVM-7200 Series Vital Sign Monitor

The monitor is designed for outpatient facilities and beds that traditionally are not continuously monitored.
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Beat Stress Through New Wearable Device

Developed by physicians and neuroscientists at the University of Pittsburgh, Apollo’s gentle waves of vibration signal safety to the body through your sense of touch and rapidly improve heart rate variability, a key metric of health and recovery.
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Daavlin Partners with HealthLens

New teledermatology service is designed to provide quick diagnosis and treatment to patients with psoriasis, vitiligo or eczema.
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Owlstone Medical to Join EU-Funded EPHOR Consortium

The consortium aims to further elucidate the complex relationships between environment and disease by developing the concept of the ‘working-life exposome’, which takes into account all occupational and related non-occupational exposures (e.g. lifestyle) throughout the lifespan of an individual.
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Verantos Receives a Grant from the National Institutes of Health

The grant supports advanced scientific efforts by Verantos to define the clinical phenotype, a detailed view of patient characteristics required for RWE studies.
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LimFlow Reports First Patient Enrolled in PROMISE II U.S. Pivotal Study

The successful first case was performed by Mark Archie, MD, principal investigator for the PROMISE II trial at Harbor-UCLA Medical Center, and Nina Bowens, MD, sub-investigator for the PROMISE II trial at Harbor-UCLA Medical Center.
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3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo™

Microtia is a rare congenital disorder causing the outer ear (auricle) to be smaller than typical, misshapen, and sometimes missing at birth; most cases only affect one ear.
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BVI Acquires Arcadophtha SARL

Acquisition of Arcadophtha increases BVI's market position by adding a specialist in vitreoretinal surgical liquids and gases.
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Wave Neuroscience Completes Major Brain Treatment Technology Asset Purchase

In June 2019, Wave Neuroscience purchased substantially all of the assets from the many different onshore and offshore holding companies under NBRL.
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Orpyx® Launches Orpyx SI Sensory Insoles with Remote Patient Monitoring

By monitoring pressure, temperature, and movement, the Orpyx SI Sensory Insole system provides the wearer with real-time audiovisual alerts and allows them to immediately take action to resolve high-pressure areas that may lead to tissue breakdown.
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Vicarious Surgical Announces Breakthrough Designation by the FDA

The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment.
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Nanomix Reports They Received CE Mark for Diagnostic Panel That Aids in Rapid Identification of Serious, Life-Threatening Infections

Nanomix developed the S1 Assay to aid in the rapid detection of serious infections, including sepsis and bacteremia.
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Peer-Reviewed Publication Highlights First-of-its-Kind Continuous Monitoring Platform for Intensive Care Units

The publications provide further support for the ability of the OptiScanner to facilitate enhanced glucose level control in critically ill patients, offering key advantages over traditional, non-automated, labor-intensive glucose monitoring methods.
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Canon Medical Unveils New Educational Opportunities

Customers can access the resources they need, when they need them, through web-based learning tools, mobile-friendly resources and accredited opportunities.
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HZO Reports Launch of Next-Generation Innovation in Nano Coating Equipment, Delivering Total Waterproofing Protection

The HZO PRO800-PL delivers higher throughput with greater precision to enable lower-cost Plasma-based protective nano coatings
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First-Ever Blood Collection Tube for cfDNA/cfRNA & gDNA/RNA Pairing Launched

The Synergy Tube and proprietary stabilizer dramatically improve the quantity and quality of these components for downstream genetic diagnostics.
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