Medical Device News Magazine, a digital publication, reports the latest medical device 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. We disseminate industry updates to healthcare professionals, including medical specialists, executives in the medical device industry, investors, and other allied health professionals. This objective is achieved through the utilization of diverse social media platforms and targeted email communications to subscribers. We cordially invite you to visit us daily and explore the opportunity of advertising with us.

Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc.

Empowering Healthcare Professionals and Investors: The Rise of Next-Generation Medical Devices

World’s 1st Total Knee Replacement Patient Treated with PolarisAR Breakthrough Mixed-Reality Surgical Guidance System

PolarisAR describes STELLAR Knee as a mixed-reality surgical navigation platform that guides TKA procedures by displaying measured and computed data overlaid directly in a 3D environment. The mixed-reality system acts as a spatial computer, creating continuous data exchange between the surgeon and the software to help enhance surgical decision-making while simplifying operating room workflow.

Ultra Low Insertion Loss Athermal AWG Multiplexers

"Our ultra low insertion loss Athermal AWG Multiplexers along with temperature-hardened low-drift AAWG specifically designed for the industrial temperature applications will be marketed aggressively through partnership companies in the East Asia and EU regions after its success in the North America," says Dr. Donald Yu, CMO of POINTek, who runs global marketing operations from Los Angeles, California.

IDC Partners With XFT Medical to Create an Innovative Hand Rehabilitation Device

The rehabilitation robotic glove is a training device that combines EMG electromyographic feedback and flexible robotics for patients with stroke or hand disabilities to train and repair dexterity.

Kleiner Device Labs Presents e-Poster at Southern Neurosurgical Society Meeting

Kleiner Device Labs will attend the meeting and looks forward to demonstrating the new KG®2 Surge® flow-thru interbody system to surgeons

Medtronic Files ITC Action Against Axonics to Stop Unauthorized Use of Medtronic Innovations

“Medtronic is continuing our efforts to stop Axonics from profiting off of their unauthorized use of our innovations and intellectual property," said Mira Sahney, president of the pelvic health business in the neuroscience portfolio at Medtronic. "The pattern is clear: Axonics uses Medtronic technologies to improperly compete in the market. It is time for Axonics to be held accountable for these unlawful acts."

Internationally Acclaimed Vascular Surgeon Dr. Frank J Veith Joins ViTAA Medical Solutions Board

The addition of Frank J Veith, MD to the Board underscores ViTAA's commitment to excellence and innovation in the development of medical technologies. His vast experience and achievements will provide critical insights and direction as ViTAA continues to pursue its goal of revolutionizing patient care through cutting-edge solutions.

Featuring industry experts in the healthcare field who have come together to share their invaluable insights, perspectives, and opinions. With their wealth of knowledge and experience, these esteemed professionals provide a comprehensive understanding of the latest trends and developments in the healthcare industry. Medical Device News Magazine serves as a platform to delve into the thoughts and viewpoints of these experts, enabling healthcare professionals to stay informed and make informed decisions that will shape the future of healthcare.

Bringing Innovation to Life in the Medical Technology Industry | By Shawn Luke, Technical Marketing Engineer, DigiKey

Shawn Luke is a technical marketing engineer at DigiKey. DigiKey is recognized as the global leader and continuous innovator in the cutting-edge commerce distribution of electronic components and automation products worldwide, providing more than 15.3 million components from over 2,900 quality name-brand manufacturers. Read what he has to say.

Revolutionizing Healthcare: Latest Biotech Innovations Making Waves in the Industry

Seegene and Springer Nature Announce Awardees for the Open Innovation Program

In September 2023, Seegene and Springer Nature opened applications to scientists and experts across the global community to conduct research for the 15 designated projects to develop Seegene's syndromic qPCR diagnostics assay reagents for the Open Innovation Program.

Lindus Health Launches “All-In-One Metabolic CRO” Offering to Accelerate and Enhance Metabolic Clinical Trials

Lindus Health has taken learnings from this experience to build a bespoke "All-in-One Metabolic CRO" offering that combines the expertise of a seasoned full service CRO and internal site/PI expertise with a distinctive technology driven approach on its proprietary Citrus™ platform. This unique marriage of technology and services sets metabolic sponsors up to run faster, more patient-centric clinical trials.

Synexa Life Sciences Expands Biomarker Discovery Capabilities with the Addition of Olink® Target Platform

The addition of Olink to the Synexa Life Sciences technology portfolio demonstrates our continued commitment to strengthening our biomarker and bioanalysis capabilities across several expertise areas including oncology, immuno-oncology, infectious diseases and more.

Oncuria Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024 | Reports DiaCarta

Oncuria Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.

Unveiling the Latest FDA Regulations: What Healthcare Professionals Need to Know

FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy

Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management.

ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices™ Cardiopulmonary Management (CPM) System

Sensinel is a compact wearable device is a non-invasive, remote management system that captures cardiopulmonary measurements for chronic disease management such as heart failure. It is the first FDA clearance the company has received in its 59-year history.

Boston Scientific Receives FDA Approval for the AGENT™ Drug-Coated Balloon

The AGENT DCB is available in Europe, parts of Asia Pacific and Latin America for the treatment of patients with ISR and previously untreated small vessel coronary disease. Boston Scientific plans to launch the technology in the U.S. in the coming months.

FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer

Tabrecta is the first FDA-approved therapy to treat non small cell lung cancer with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping).

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Groundbreaking Developments Shaping Modern Hospitals

4th Hospital is Now Equipped with Quantum Surgical’s Minimally Invasive Surgical Robot That Kills Tumors

Epione® is a robot-assisted technology that enables interventional radiologists to perform safe and effective percutaneous tumor ablations, a minimally invasive treatment where one or more needles are inserted through the skin to destroy the tumor. This platform is designed to plan, target, execute, and confirm the ablation of abdominal and pulmonary tumors, with other locations currently under study.

Northwell Health Named One of the World’s Most Ethical Companies for 2024

Ethisphere, which announced the list today, is a global leader in defining and advancing the standards of ethical business practices. Northwell Health was recognized because of its culture, practices, and compassionate care, and for treating some of the most diverse communities in the world.

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Top Expert Bylines

Bringing Innovation to Life in the Medical Technology Industry | By Shawn Luke, Technical Marketing Engineer, DigiKey

Shawn Luke is a technical marketing engineer at DigiKey. DigiKey is recognized as the global leader and continuous innovator in the cutting-edge commerce distribution of electronic components and automation products worldwide, providing more than 15.3 million components from over 2,900 quality name-brand manufacturers. Read what he has to say.

The Importance of Temperature Monitoring and Accuracy During Cold and Flu Season | by Dr. Audrey Sue Cruz

What consumers and health professionals may not realize is the critical importance of utilizing proper temperature monitoring tools, to stay informed about their health, and also to evaluate the severity of illness, helping to determine if medical attention is needed. Learn more.

Medical Associations

Data Shows Significant Prevalence of Sleep Apnea Among Cardio-Oncology Patients

Sleep apnea is a disorder of altered breathing while asleep with two types, obstructive (OSA) or central (CSA). Both can be treated to alleviate symptoms and improve cardiovascular outcomes. This study pertains to obstructive sleep apnea.

CT Scan is Most Effective to Assess People with Chest Pain

Recent randomized clinical trials have demonstrated a benefit to using CT Scan first in evaluation of these patients, and a new study being presented at the American College of Cardiology Cardiovascular Summit lends credence to this strategy, finding that CT was associated with a higher likelihood of revascularization compared to other imaging modalities or no testing.

Key Clinical Trials Unveiled: Insights for Healthcare Professionals and Savvy Investors

NYU/Brain: Brain Recordings in People Before Surgery Reveal How All Minds Plan What to Say Prior to Speaking

Led by researchers at NYU Grossman School of Medicine, the study results add to evidence that neighboring brain regions, the inferior frontal gyrus and the motor cortex, play an important role in such planning before words are said aloud. Both are part of the folded top layers of the brain, or cerebral cortex, which has long been known to control the muscle (motor) movements in the throat and mouth needed to produce speech. Less clear until now was how closely these regions determine the mix of sounds and words people want to say aloud, the authors report.

Aquedeon Medical Announces First Patient Enrolled in the IDE Study of Duett Vascular Graft System

This February, the first enrolled patient underwent open surgical aortic arch reconstruction at the University of Pennsylvania, Presbyterian Medical Center, Philadelphia, PA.  During the surgery, the Duett Vascular Graft System was successfully deployed to connect the native left common carotid artery to the surgical graft.

Auxilius Pharma Announces Top-line Results of its First-in-Human Clinical Study into the Pharmacokinetics, Safety and Tolerability of Antianginal AUX-001

AUX-001 is an innovative, once-daily, extended-release formulation of Nicorandil. For decades, immediate-release, twice daily Nicorandil has been a cornerstone treatment for chronic angina symptoms outside the US, distinguished by its dual mechanism of action that targets both the micro- and macrovascular coronary artery flow bed, and providing sustained angina symptom relief without the common issue of tachyphylaxis seen with other anti-anginal vasodilators like long-acting nitrates. AUX-001 offers efficacy comparable to conventional anti-anginal medications such as beta-blockers, calcium channel blockers, and long-acting nitrates while also potentially enhancing control of the underlying coronary disease and reducing angina related hospitalizations.

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Unveiling the Latest Medtech Financial Breakthroughs: What You Need to Know

Bone Health Technologies Raises $5M to Launch Bone Density Wearable

Bone Health Technologies Bone Health Technologies (BHT), a health technology innovator developing breakthrough non-invasive solutions for bone health, today announced the company has raised a...

Nektar Therapeutics Announces $30 Million Private Placement Financing with TCGX

Howard Robin, President and Chief Executive Officer of Nektar Therapeutics: "We are pleased to bring on TCGX as a new high-quality, long-term investor in Nektar as we advance rezpegaldesleukin through our Phase 2b studies in atopic dermatitis and alopecia areata. We are on track to report topline data from these studies in the first half of 2025, which will represent significant inflection points for Nektar. Today's financing further bolsters our financial position and extends the company's cash runway well into the third quarter of 2026."

MMI Raises $110 Million in Series C Financing

MMI notes the funds will support commercialization of the Symani® Surgical System in high-growth markets and continued investment in studies that generate clinical evidence and enable indication expansion. Investments will also accelerate advanced technology capabilities and enable MMI to scale its operational capabilities globally.

Tevogen Bio Announces $8 Million Equity Investment

“We are excited to begin our journey as a public company with this additional investment. We believe Tevogen’s patient-centric approach, which merges a focus on affordability with advanced science, is a blueprint for sustainable success in the current era of healthcare. I am pleased that investors now have the opportunity to participate in Tevogen’s mission to become the very first life science company offering commercially attractive and affordable personalized T cell therapies for large patient populations in virology, oncology, and neurology, said the CEO of Tevogen Bio.

Cutting-Edge Diagnostic Imaging Techniques Revolutionize Medical Diagnostics

Lunit Expands Presence in Europe | To Deliver AI-powered Cancer Screening Solution to France and Portugal

New supply contract to bring Lunit INSIGHT CXR to TeleDiag in France and Lunit INSIGHT MMG to the Central region branch of the Portuguese League Against Cancer

KA Imaging Reports Record Revenue Plus Strategic Hires

KA Imaging reported a collection of positive metrics to its stakeholders, with revenue four times larger than that of the previous year and a 38% growth in headcount in 2023. The positive trend continues to be observed in Q1 2024.

Sectra Reports Enterprise Imaging Solution Now Covers Majority of Midwest Patients Following New Contract

Isaac Zaworski, President of Sectra advises: "Collaborating across sites and providing efficient radiology workflows are needed to cope with the increasing imaging volumes. This new customer is the 60th healthcare provider to use Sectra in the US Midwest and I'm pleased to be continuing our work in this area. With our local experience as well as our knowledge in providing multi-site solutions for large organizations we will help them on this journey in the best way possible."

MediView Announces Study Results Demonstrating High Registration and Targeting Accuracy of Augmented Reality-Based Navigational Guidance System

MediView notes the system, which has received 510(k) clearance from the U.S. Food and Drug Administration and is currently in clinical use, is intended to be used adjunctively for minimally invasive ultrasound guided needle-based procedures for soft tissue and bone.

Philips Launches New AI-enabled CT 5300 at #ECR2024

The new CT 5300 system is already installed at several European hospitals and has been well-received. “CT 5300 offers CT imaging from head to toe, combined with high-end functionality such as coronary angiography, delivering an extremely broad spectrum of applications, helping us to better manage increased volumes of patients,” said Dr. Hilmar Kühl, Head of Radiology at St. Bernhard-Hospital Kamp-Lintfort, Germany. “With this latest system from Philips, we see an improvement in image quality with Precise Imaging, and for the first time, we can now visualize cardiac anatomy by using Precise Cardiac nearly artifact-free, which is very valuable to help improve cardiac care for our patients.”

Philips Launches New Azurion Neuro Biplane System at ECR2024

“Working closely with leading interventionists, we designed the latest Azurion neuro biplane to meet their requirements of superior patient care, optimized angio suite performance, and efficient return on investment.  Together, I am confident we can continue to reduce the impact of stroke, helping more patients to recover faster and reducing long-term impact on their health," said Mark Stoffels, Business Leader of Image Guided Therapy Systems at Philips.

Philips LumiGuide, the “3D Human GPS System Powered by Light” | Paves the Way for Radiation-free Minimally-invasive Surgery

LumiGuide, powered by Fiber Optic RealShape (FORS) technology, enables doctors to navigate through blood vessels using light, instead of X- ray. “[It’s] one of the most exciting changes that we’ve seen with imaging certainly throughout my career,” said Andres Schanzer, Vascular Surgeon, at UMass Memorial Medical Center, Worcester, MA, USA.

Carestream Health Earned 70 New Patents In 2024

Carestream Health notes twenty-seven of the patents were awarded by the U.S. Patent and Trademark Office; an additional 43 patents were received in European and Asian countries.

Unveiling the Future: Medical M&A Insights

Linus Health Acquires Aural Analytics

"Thanks to the nature of software, our platform can distribute new, advanced and validated digital diagnostics to the market globally with unprecedented speed," said Linus Health CEO and Co-Founder David Bates, PhD. "As with any chronic illness, earlier detection of brain-related disabilities allows for intervention that can delay, modify or even prevent progression of the disease. It's why we are engineering the most inclusive approach to assessing and monitoring brain function, one that includes speech and movement, in addition to memory and other neurological functions."

Haemonetics Announces Definitive Agreement to Acquire Attune Medical

Jay Istvan, Chief Executive Officer at Attune Medical, "We are thrilled to become part of Haemonetics. Their Hospital business has strong positions in both EP and critical care, and their international channels are robust and expanding. We believe Haemonetics is the best company to bring ensoETM's substantial benefits to more caregivers worldwide to enable new standards of care."

Wave Neuroscience Acquires Assets of NeoSync

In addition, Wave Neuroscience has acquired the Neuro-EEG Synchronization Therapy (NEST®) system developed and tested by NeoSync.

Boston Scientific Announces Agreement to Acquire Axonics, Inc.

Boston Scientific expects to complete the transaction in the first half of 2024, subject to customary closing conditions.

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Executives on the Move

Jennifer Riter Appointed VP of Analytical Services at Kindeva Drug Delivery

Jennifer Riter comes to Kindeva from West Pharmaceutical where she spent the past 27 years in various technical and leadership roles, most recently serving as the Senior Director, Business and Technical Operations.

Christine Senn, PhD Appointed Senior Vice President, Head of Site-Sponsor Innovation at Advarra

Chistine Senn will serve as Chair of the Site-Sponsor Consortium – a collaborative body now in its second year – and as Chair of Advarra's Customer Advisory Board. She will also drive and oversee the development of innovative ways to bring clinical trial sites and sponsors together in support of Advarra's mission.

Christopher Slachta Joins Cytovale as Chief Operating Officer

Christopher Slachta joins Cytovale after serving 12 years at Abbott, most recently as divisional vice president of global operations and supply chain, molecular diagnostics.

Val Kolesnitchenko, MD Named Ace Vision Group Chief Scientific Officer | Over 3 Decades of Clinical Ophthalmology Practice & Industry Experience

Dr. Val Kolesnitchenko brings extensive ophthalmology experience in clinical practice and industry to new therapeutics for the aging eye.

BRIJ Medical Welcomes Tim Gleeson as CEO and Joe Andrew as SVP of Sales

These strategic appointments signify a significant milestone for BRIJ Medical as they usher in a new era of post-surgical and trauma incision care with proven technologies that minimize wound complications and scarring.

Eckhard von Keutz, PhD Appointed to the Phenovista Scientific Advisory Board

Dr. Eckhard von Keutz has extensive experience in designing and conducting preclinical/toxicological studies, and toxicological risk assessment and management.

Nurse's Corner

5 Tips to Improving Your Performance as a Nurse

No matter where you work or what your specialty is, your core duty as a nurse remains the same: Provide quality care to your patients. While providing bedside care is a big part of what you do, though, it is not the only aspect of nursing that you need to be mindful of. There are charts to fill out,...

Skills And Qualities You Need To Be A Mental Health Nurse

Considering this career path? Read on to find out what you need to know!

Why Do Nurses Wear Scrubs?

In the past, nurses wore what most people think of as the classic nurse uniform consisting of a starched white dress and cap. Descended from the original nurse uniform, the nun habit, one of Florence Nightingale’s students designed the look of the cap and dress during the early 20th century. Nurses worldwide donned the nurse gown in various forms...

Strong Writing Skills for Practicing Nurses – Is It a Necessary One for a Nursing Student?

Prominent writing skills are crucial for any scientific industry, particularly for future nursing experts who should establish trusting communication with patients and colleagues. Good writing talent is vital in a professional context to be able to make considerable career progress, no matter whether you’re new in the field or already a practicing nurse. In this brief overview, we'll discuss the...

Noteworthy

Manufacturer of Industrial Telescopic Slides and Linear Guide Rails

Industrial telescopic slides and linear guide rails are used in various applications, including manufacturing equipment, machine tooling, and industrial automation. Read on to learn more.

The Role of Real-World Evidence in Economic Modeling

This discusses the essence of real-world data, and its growing importance in modern economic modeling.

Capitol City Residential Health Care Shares Five Tips For Celebrating Business Milestones

By following Capitol City Residential Health Care tips, companies can create meaningful and impactful milestone celebrations that boost employee morale and positively contribute to their company culture. Read on to learn more.

The Intersection of Passion and Profession: Crafting a Fulfilling Career in Tech

As with any job, there are pros and cons that need to be considered before deciding if a career in tech is for you. Read on to learn more.

Cutting-Edge Techniques in Gene Therapy

Gene therapy is a rapidly evolving field that holds promise for the treatment of countless diseases. But what do you think are the most significant challenges and opportunities in gene therapy today? Read on.

5 Pieces of Medical Equipment Every Assisted Living Home Should Have

One of the biggest benefits of opting to have a loved one cared for in an assisted living facility is that you’re ensuring they receive better medical support than you’d be able to provide in the event of an emergency.

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Unlocking Success in Medical Business

The D-Actor 100 from STORZ Medical: Revolutionizing Pressure Wave Therapy Standards

The D-Actor 100 by STORZ Medical stands out in this field and is recognized as a leading device for healthcare professionals seeking effective treatment outcomes. This technology utilizes pressure waves to stimulate the body's natural healing processes, improving circulation and cell regeneration through microtrauma in targeted tissues.

Healthcare Professionals / Career Corner

Online Medical Admin Assistant Programs: Your Guide to Success

Overall, online medical administrative assistant programs offer many benefits like convenience, lower costs, self-paced learning, and preparation for an in-demand career. Read on.

How To Write a Medical Assistant Entry-Level Resume: Career Clarity Guide

Medical assistants perform clerical and technical tasks under the supervision of a registered nurse or other healthcare professional. Most support roles require little to...

Health / Lifestyle

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