Wednesday, January 22, 2020
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

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.

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...

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.

EXECUTIVES ON THE MOVE

MARKET REPORTS

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

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.

Flow Cytometry Market

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%.

BREAKING MEDICAL DEVICE INDUSTRY NEWS

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
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.
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.
The AIROS 8 Sequential Compression Therapy device uses pneumatic air compression to inflate accessory garments worn on the affected area of the body.
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.
In May 2017, DABRA received FDA 510(k) clearance for use in ablating a channel in occlusive peripheral vascular disease (PAD).
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.
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.
FEops reports the trial is led by Righshospitalet, Copenhagen, Denmark.
Advanced ICU Care states the tele-ICU care will support patients in the hospital's Intensive Care Unit and Coronary Care Unit.
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.
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.
With this strategic alliance, Invicro can now represent Paige’s digital diagnostic and biomarker solutions in the global pharma services market.
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.
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.
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.
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.
FDA's Breakthrough Device Designation Program allows for priority review of the Phagenyx® System.
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.
Carevature Medical's Dreal® technology has assisted surgeons in over 1,500 cases, both non-fusion and fusion.
Fourth FDA clearance makes Aidoc the comprehensive solution for radiology AI.
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.
WatchPAT has been selected for inclusion in the Weizmann Institute’s Project 10K. 
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.
“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.”
Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments.
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.
The new dental filling material mimics the properties of natural teeth.
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.
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.
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.
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.
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.
The business unit, which will facilitate the supply of mission-critical, high-value components, materials, and solutions to medical device manufacturers worldwide.
Etonogestrel/Ethinyl Estradiol Vaginal Ring is a small, flexible vaginal ring used by women to prevent pregnancy.
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.
The round was led by Northpond Ventures, a global firm dedicated to science and technology headquartered in Bethesda, Maryland.
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.
The 1.25 Micro Crown is designed with flexibility for tortuous vessels and tight bends below the knee.
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.
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.
Expands testing and repair capabilities.
Results of the study were presented yesterday at the 58th Annual Meeting of the American College of Neuropsychopharmacology.
The monitor is designed for outpatient facilities and beds that traditionally are not continuously monitored.
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.
New teledermatology service is designed to provide quick diagnosis and treatment to patients with psoriasis, vitiligo or eczema.
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.
The grant supports advanced scientific efforts by Verantos to define the clinical phenotype, a detailed view of patient characteristics required for RWE studies.
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.
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.
Acquisition of Arcadophtha increases BVI's market position by adding a specialist in vitreoretinal surgical liquids and gases.
In June 2019, Wave Neuroscience purchased substantially all of the assets from the many different onshore and offshore holding companies under NBRL.
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.
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.
Nanomix developed the S1 Assay to aid in the rapid detection of serious infections, including sepsis and bacteremia.
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.
Customers can access the resources they need, when they need them, through web-based learning tools, mobile-friendly resources and accredited opportunities.
The HZO PRO800-PL delivers higher throughput with greater precision to enable lower-cost Plasma-based protective nano coatings
The Synergy Tube and proprietary stabilizer dramatically improve the quantity and quality of these components for downstream genetic diagnostics.