Friday, December 1, 2023

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Medical Device News Magazine
Friday, December 1, 2023

Contact: 561.316.3330

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Medical Device News Magazine is a digital publication that provides readers with breaking medical device / biotech industry news, such as clinical trial and FDA updates, acquisitions and mergers, views and opinions from industry experts and much more.

Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in learning about what’s new in medical devices and technologies.

Medical Device News Magazine is a fast 1, 2, 3 easy read! Learn more.

Featured News

Refeyn Launches KaritroMP for Rapid and Reproducible Characterization of Large Viral Vectors

Unlike classical mass photometry technology, KaritroMP utilizes light scattering to measure both the size and contrast of single particles, allowing for large particles such as AdVs and LVVs to be characterized across two dimensions.

Inspira Technologies Collaborates with Ennocure for development of a Proprietary Bio-Electronic Treatment to Prevent Associated Bloodstream Infections in ICU Patients

Dagi-Ben Noon, CEO of Inspira Technologies, reflects on the partnership's significance: "By Integrating our technology to oxygenate blood directly with Ennocure's infection prevention solutions, we are focusing on potentially improving patient outcomes in ICUs and paving the way for safer, more effective life-support treatments. This collaboration is expected to accelerate the development and broaden the implementation of our advanced technology."

Expert Moves: The Essential Guide to Choosing Lab Moving Companies

Discover the essential factors to consider when choosing a lab moving company. Learn how specialized services, experience, and proper planning can ensure a seamless and secure lab relocation.

Function of Research Liquids in Biomedical Researches

Research liquids are the key accessories for various research processes, and Lotilabs offers the best quality research liquids.
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Mergers / Acquisitions

Boston Scientific Closes Acquisition of Relievant Medsystems, Inc.

he Intracept system, a basivertebral nerve ablation therapy, will be an addition to the Boston Scientific chronic pain portfolio that includes spinal cord stimulation, radiofrequency ablation and an interspinous spacer procedure.
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Funding

Savage Medical Exits Stealth With Over $3 Million to Enable Minimally Invasive Colorectal Tumor Removal

The groundbreaking ColoSeal System™ enables minimally invasive colorectal tumor removal, eliminating the need for 2 open surgeries in today's standard of care notes Savage Medical.

Alto Neuroscience Closes $45 Million in Oversubscribed Series C Financing

Alto Neuroscience advises the funds will be used to support ongoing and planned late-stage clinical development of CNS product candidates with four Phase 2 readouts expected across the next 12-18 month
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Nico Corporation Improving The Outcomes In The Deadliest Type Of Stroke

Industry Executives Views & Opinions

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CAR T Cell Therapy Is Offering Life-lines to Cancer Patients, but Only to Those Who Can Afford It | By Dr. Brandon McNaughton, Chief Executive Officer and Co-Founder of Akadeum

The creation of CAR T cell therapy begins with collection of the patient’s blood and separation of the lymphocytes. These include T cells, B cells, and innate lymphoid cells, all of which are separated through apheresis (leukapheresis). It is this separation process which, if optimized, has the potential to revolutionize immunotherapy treatments for cancer patients.
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Clinical Trials and Updates

Research Team at UNC Validates PixCell Medical’s HemoScreen as Game-Changer for Clozapine Monitoring in Psychiatry

Clozapine has been established as the most effective antipsychotic medication for treatment-resistant schizophrenia. However, it is significantly underutilized mainly due to the risk of developing agranulocytosis and the need to frequently monitor the absolute neutrophil count (ANC).

Clinical Validation Data Published in CHEST Demonstrate that Veracyte’s Percepta Nasal Swab Test Improves Lung Cancer Risk Assessment for Patients with Lung Nodules

The findings suggest that the novel, non-invasive genomic test can help physicians guide next steps for these patients, enabling them to potentially avoid unnecessary invasive procedures or accelerate time to appropriate treatment.

BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

“These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX. “In Part 2 of the study, BX004 showed clinically meaningful improvement in pulmonary function compared to placebo, as measured by relative FEV11 improvement (5.67% at Day 17, 1 week after end of treatment) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain (8.87 points at Day 17) in a predefined subgroup of patients with reduced lung function.”  

InGeneron Announces Critical In-Depth Analysis of the Results from a Recently Published 480-Patient Phase III Knee Osteoarthritis Trial

Importantly, the study reported no serious treatment-related adverse events from any of the 109 patients treated with InGeneron’s Transpose® RT cell therapy system.
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Our Experts Share Their Thoughts

New Living Blood Vessels Created Through Restorative Devices Open Unthinkable Treatment Avenues | By Eliane Schutte, Xeltis CEO

The latest results from a clinical trial presented today at the VEITHsymposium in New York City demonstrate how new living blood vessels created through restorative medical devices have become reality and can open unthinkable treatment avenues for patients. Xeltis is developing cardiovascular devices, namely artificial vessels and valves, that gradually create living and long-lasting vessels made of patients’ own, new healthy tissue.

Meet the Two 17-year-olds Who Skipped 60 Days of School to Build a $12.5M NeuroTech Startup | Sai Mattapalli and Rohan Kalahasty

In the dynamic realm of entrepreneurship, where seasoned professionals often take center stage, the story of Sai Mattapalli and Rohan Kalahasty — both 17-year-old high school seniors — emerges as a beacon of inspiration. 

Radiology’s Looming Labor Gap: How Emerging Technology Can Address this Labor Shortage and Better Serve Providers, Patients and Health Systems | By Evan Ruff,...

Within two years, the U.S. will have a shortage of 98,700 medical and lab technologists and more than 80% of health systems are currently reporting shortages in their radiology departments. More than half of the radiologists in the U.S. are 55 and older, and the flow of residents to fill the gap isn’t nearly big enough. The staffing shortage is even more acute among radiation technologists and in the U.K., 97% of radiology departments cannot meet diagnostic reporting requirements.

A Lifesaving Shunt in the Heart? | By Dr. Sheldon Litwin

Dr. Litwin advises, "Approximately 60 study sites worldwide are participating in RESPONDER-HF, a randomized clinical trial of the Corvia Atrial Shunt." What to know more about this life-saving device? Read what this expert has to say.
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Imaging

AI Innovation for Automated Detection and Classification of Osteoporotic Fractures of the Spine in CT Scans | ImageBiopsy Lab launches IB Lab FLAMINGO

"Our partnership with UCB highlights the potential of leveraging AI for improving care for many diseases, including osteoporosis" explains Richard Ljuhar, CEO at ImageBiopsy Lab.

Research from Philips and Vanderbilt | Shows How Decarbonizing Healthcare Also Helps to Reduce Cost

Philips and Vanderbilt assessed 13 diagnostic imaging devices including MR, CT, ultrasound and X-ray, which account for an estimated 12,000 patient scans per month and found that, over a period of 10 years, they emit the CO₂ equivalent of approximately 1,000 gas cars driven for one year.

United Imaging Healthcare – Manufacturer of High Quality Medical Equipment

Advanced molecular imaging, magnetic resonance, computed tomography and digital radiography technologies from market leader United Imaging Healthcare are breaking new ground in medicine and helping to improve the quality of patient care around the world.
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FDA

Zilia Receives FDA Clearance for its Zilia Ocular™ FC Retinal Camera

"Receiving this first FDA clearance for our retinal camera is not just a milestone, it's a leap forward in our quest to safeguard the vision of millions," said Dr. Patrick Sauvageau, optometrist, CEO, and co-founder of Zilia. "We're now focused on obtaining De Novo classification for ocular oximetry, a breakthrough biomarker that promises to revolutionize how we diagnose and manage a variety of ocular conditions."

Brainomix Targets US Expansion with the Launch of its Cutting-Edge Stroke AI Platform Following Series of FDA Clearances

The recent FDA clearances included Brainomix 360 e-CTP and Brainomix 360 e-MRI, both software modules that can support thrombolysis and thrombectomy treatment decisions, particularly for late-window patients who present to hospital more than 6-12 hours after stroke onset.

GE HealthCare Announces New Version of Digital Expert Access, the First FDA 510(k)-Cleared Device to Enable Remote Patient Scanning, and Exclusive Distribution Agreement with IONIC Health

IONIC Health’s 510(k)-pending nCommand Lite technology is designed to include vendor-agnostic remote scanning capabilities. This strategic collaboration’s goal is to enable GE HealthCare to provide a multi-vendor, multi-modality remote scanning solution to healthcare systems and patients around the globe.

Executives on the Move!

Dr John Parker Joins PeriGen as Chief Medical Officer, Bringing Expertise to Advance Maternal and Infant Healthcare

Dr John Parker will work closely with PeriGen's client base to optimize use of the company's analytics for patient care and research. He will also be instrumental in informing product development and regulatory affairs as PeriGen continues to expand its product suite and associated services.

PrecisionLife Announces New Appointments to Launch Diagnostics and Healthcare Strategy | Dr Gerald Dunstan & Hannah Bibby

“We’re delighted to welcome Gerald and Hannah to the PrecisionLife team at a time when our deep disease insights and patient stratification biomarkers are finding important new markets and bringing precision approaches to the early, more accurate diagnosis and care of patients with complex chronic diseases,” said Dr Steve Gardner, PrecisionLife CEO.

Broken String Biosciences appoints Gavin Burns as Vice President of Quality and Operations

Broken String Biosciences reports Gavin Burns will be responsible for building and optimizing the companys teams, processes, and systems.

Aptar Digital Health Expands Oncology Clinical Advisory Board

“We are pleased to strengthen our Clinical Advisory Board and to welcome our new members,” commented Pierre Leurent, President, Aptar Digital Health. “Their broad medical expertise will allow us to have a deeper knowledge and expand our global vision of the clinical practice for multiple types of cancer.”
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Market Reports

Hernia Mesh Devices Global Market Analysis Report 2023, with Coverage of Key Players Johnson & Johnson Services, C. R. Bard, Atrium Medical, LifeCell, B. Braun, Baxter and Cook

The global hernia mesh devices market size is expected to reach USD 8.32 billion by 2030, registering a CAGR of 6.7% during the forecast period. The growth is owing to an increase in the incidence of hernias, and the high adoption of meshes in surgeries due to factors such as reduced operative time, cost-effectiveness, reduced pain, and high availability of products in the market.

Global Hybrid Operating Room Equipment Market Report 2023-2028 – Surgical Oncology and Aesthetic Surgery are Key Applications Set to Increase the Adoption of HORs During the Forecast Period

The "Hybrid Operating Room Equipment: Global Markets" report has been added to ResearchAndMarkets.com's offering. A hybrid operating room is adopted mainly for complex cardiovascular, neurological, orthopedic, and other surgeries. Rapid technological development and demand for open and minimally invasive surgeries are the key factors driving the growth of the global hybrid operating room market. The increasing number of surgical application areas will also inject growth within the market. Surgical oncology and aesthetic surgery are key applications that will increase the adoption of HORs during the forecast period.

Spinal Surgery Devices Market Report 2023 – Robotics, Minimal Interventions, New Payment Models and Data Integration Provide Growth Opportunities

The "Growth Opportunities in Spinal Surgery Devices" report has been added to ResearchAndMarkets.com's offering. The aim of this study is to analyze the innovative spinal surgery devices propelling market growth as the adoption rate of minimally invasive surgery (MIS) increases in the spinal surgery sector.
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Association News

AI Model Predicts Breast Cancer Risk Without Racial Bias

Traditional breast cancer risk assessment models use information obtained from patient questionnaires, such as medical and reproductive history, to calculate a patient’s future risk of developing breast cancer.

Common Headaches Tied to Neck Inflammation

RSNA notes: The distinct underlying causes of primary headaches are still not fully understood. The most common primary headaches are tension-type headaches and migraines.

RSNA Announces Abdominal Trauma Detection AI Challenge Results

The latest in a series of research competitions that RSNA has conducted since 2017, the RSNA Abdominal Trauma Detection AI Challenge represents the Society’s most ambitious AI challenge to date, encompassing detection and classification of traumatic injuries across multiple organs, including the liver, spleen, kidneys, and bowel. The international imaging dataset is the first multiphasic dataset that RSNA has assembled for a challenge and is one of the largest and most varied of its kind, including detailed clinical labels, radiologist annotations and segmentations.

Marijuana and Cigarette Smokers at Increased Risk of Emphysema

The researchers found that people who combined marijuana and cigarettes were 12 times more likely to have centrilobular emphysema than non-smokers. Centrilobular emphysema is a type of pulmonary emphysema where the air sacs within the lungs are damaged. This can lead to breathing difficulties and other serious respiratory symptoms.
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Hospitals

Northwell Health Opens 2 New Medical Imaging Schools at its Center for Learning and Innovation

The new School of Diagnostic Medical Sonography – created with SUNY Empire State University as an academic partner – will teach the next generation of diagnostic medical sonographers. Additionally, Northwell’s Peconic Bay School of Radiologic Technology opened a second campus at CLI, doubling its class size.

Skip Therapeutics and Sheba Medical Center to Collaborate for the Development of RNA-based Treatments for Rare Diseases

Under the terms of the agreement, Sheba Medical Center will share with Skip Therapeutics its de-identified patient mutation repository and Skip will provide a bioinformatic assessment of the possibility to use ASOs to circumvent the mutation, restore protein function and constitute a relevant therapeutic path.

Northwell Launches $500 Mil Initiative | To Expand Pediatric Mental Health Services and Access to Care for Children and Teens

The plan includes a $350 million investment from Northwell toward capital, programs, services, and operating costs as well as a goal to fundraise $150 million through philanthropy.

King Faisal Specialist Hospital and Research Centre Utilizes Early Cancer Detection Technology for 50 Genes

This technology presents a safer alternative to traditional biopsies for patients facing challenges in accessing affected tissue without surgical intervention, as seen in cases like lung cancer. It is particularly beneficial for elderly patients, for whom a lung tissue biopsy may not be suitable due to the potential for severe complications associated with it.
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Noteworthy

Blending Emerging Healthcare Technologies with Modern Medical Furniture in the Post-COVID Era

This article explores the integration of emerging healthcare technologies with modern medical furniture, focusing on products like Procedure Chairs, 3-Section Treatment Tables, Examination Tables, and Podiatry Chairs, and how they are evolving in response to these advancements.

“Navigating Wellness: The Transformative Power of Behavioral Health Software Systems”

Behavioral health software systems are more than just digital tools; they are compassionate companions on the journey to mental wellness. From mood tracking to personalized resources, these systems provide individuals with a versatile array of features that empower them to actively engage in their mental health journey.

Expert Moves: The Essential Guide to Choosing Lab Moving Companies

Discover the essential factors to consider when choosing a lab moving company. Learn how specialized services, experience, and proper planning can ensure a seamless and secure lab relocation.

Laser Cutting in Medical Device Manufacturing: A Comprehensive Guide

Laser cutting plays a critical role in medical device manufacturing, offering unmatched precision, flexibility, and efficiency. Read on.This article delves into why and how laser cutting is pivotal in this field, exploring its mechanics, types, materials, and implications for the future of medical technology.
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Physician's Corner: Practice Management / Education/Careers

Navigating the Digital World: What Doctors Are Doing About Bad Reviews Online

Positive and negative online reviews can be managed in various ways. In this article, we'll explore how doctors manage their online reputation and learn how to respond to negative patient reviews.

Streamlining Private Practice Management in the Digital Age

The healthcare field is changing fast. Many hospitals and companies are buying up about 14,000 independent practices in 2021. To compete as a private practice, it's crucial to use technology. Things like virtual care platforms can make medical tasks easier. By using these, private practices can focus on providing excellent patient care.

The Key Traits Needed by Healthcare Leaders and How You Can Develop Them in Yourself

Healthcare is a dynamic and demanding field that requires exceptional leadership at every level. Whether you're a healthcare...
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Nurses Corner

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Health / Lifestyle

Stirring the Pot of Personal Wellness: A Fresh Perspective on Women’s Health Care

In the sprawling tapestry of healthcare, a significant thread is often overlooked—women's health. This vital area of focus...

Insights from Dr McIver: Parent’s Guide to Hypothyroidism in Children

As parents, ensuring the health and well-being of our children is a top priority. One aspect of pediatric...

Navigating the Intersection of Mental Health and Workplace Safety: Understanding the Role of a WSIB Psychologist

In today's fast-paced and demanding work environments, mental health is increasingly recognized as a crucial aspect of overall...

Custom Orthotics: Combining Modern Technology With Personalized Care

In the dynamic world of foot care, the intersection of technology and personalized treatment has brought about a...

The Unseen Value of Home Care Services

Modern society has evolved tremendously in the way we view healthcare. The rise of home care services is...

How the Medical Industry is Utilzing CBD

Introduction to CBD: CBD, or cannabidiol, has been making waves in the medical industry with its potential to revolutionize...

Hip Replacement Surgery Recovery Timeline | Kardiolita Hospital

Total hip replacement therapy, or arthroplasty, is a major surgical intervention involving the removal of the damaged or...

From Challenge to Tranquility: Navigating Birth Complications

This article guides you through understanding these complications, their emotional impact, and how to seek professional help. We'll...
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Articles of Interest

5 Ways to Use Credit Card Rewards for Travelling!

Are you a travel enthusiast with a keen eye for value for money? If so, you're in the...

Lessons from History Offer Profound Insight Into Challenges of Our Time | New Essays Celebrating Wisdom of the Past 2,500 Years Comprise Latest Book...

“In Rome 476, author David Parker awakens readers to the wisdom of 5th century Athens, 1st century Rome and 18th century Age of Enlightenment. Gleaning wisdom from the great thinkers and statesmen of the past, Parker’s mission is to educate fellow Americans in the historical, cultural, and founding principles of our country.” — Jeffrey Sikkenga, Executive Director, The Ashbrook Center

7 Ways a Personal Injury Lawyer Can Help You Settle Claims

Dealing with the aftermath of an injury can be overwhelming. You may be facing medical bills, lost wages,...

The Ultimate Guide on Where To Buy Delta 9 Vape Pens

Vaping has become a popular way of relaxing and enjoying the benefits of Delta 9 THC. Delta 9...
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