Monday, December 4, 2023

Contact: 561.316.3330

Medical Device News Magazine
Monday, December 4, 2023

Contact: 561.316.3330

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

Skin Cancer and Reconstructive Surgery Center of California Adopts AI-driven Nevisense for Early Skin Cancer Detection

The Nevisense System is a first-of-its-kind AI-driven technology that uniquely addresses the complexities of point-of-care detection of the deadliest form of skin cancer by providing clinicians with advanced analysis of irregular moles during routine skin checks.

Nona Biosciences Announces Collaboration Agreement with Lycia Therapeutics

"We are pleased to enter into this collaboration with Lycia Therapeutics, extending our service footprint to the area of extracellular protein degradation. We believe Lycia's leveraging of our antibody discovery capabilities will help accelerate its efforts to advance novel protein degrader therapeutics," said Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences said.

First Patient Dosed in European Named Patient (Early Access) Program for TLX250-CDx, Telix’s Kidney Cancer Imaging Agent

Through this named patient program in the Netherlands ('Leveren op Artsenverklaring'), physicians may seek individual access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC. The first patient was dosed at Radboud University Medical Centre in Nijmegen, Netherlands.

Strata Oncology Announces Presentations on Proprietary Multivariate Biomarkers at North America Conference on Lung Cancer and San Antonio Breast Cancer Symposium

Strata Oncology notes the data to be presented includes results for innovative, proprietary predictive biomarkers for response to anti-PD-1/PD-L1 immunotherapy and antibody-drug conjugates (ADCs) -- the Immunotherapy Response Score (IRS) and ADC Treatment Response Score (ADC TRS), respectively.

Mergers / Acquisitions

Supercell Acquires Exclusive Licensing from Japanese Immunotherapy Leader for Advanced NK Cell Treatment Technology

Supercell Biotechnology Corporation commemorates the first anniversary of rebranding...


Kazia Therapeutics Announces $2 Million Registered Direct Offering

Kazia has also agreed to issue in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,444,445 ADSs. The warrants will have an exercise price of $0.583 per ADS, will be immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance. The closing of the offering is expected to occur on or about December 5, 2023, subject to the satisfaction of customary closing conditions.
Nico Corporation Improving The Outcomes In The Deadliest Type Of Stroke

Industry Executives Views & Opinions

Read What Our Medical Device News Experts Have to Say

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.

Clinical Trials and Updates

Stoke Therapeutics Presents Data From Multiple Studies of Children and Adolescents With Dravet Syndrome at the American Epilepsy Society 2023 Annual Meeting

Data from clinical studies of STK-001 demonstrated clinical benefit for patients ages 2 to 18 years old, including reductions in seizures and improvements in cognition and behavior that support the potential for disease modificatio. Analysis of 72 patients treated in STK-001 clinical trials suggests that higher STK-001 drug exposure in brain leads to greater seizure reductions. Two-year data from the longest prospective natural history study of Dravet syndrome showed that, on average, patients experienced no meaningful improvement in convulsive seizure frequency and exhibited widening gaps in cognition and behavior despite treatment with the best available anti-seizure medicines.

Exact Sciences Presents Multiple Studies at San Antonio Breast Cancer Symposium Supporting Optimization and Individualization of Therapy for Breast Cancer Patients

"Exact Sciences is looking forward to presenting new evidence at SABCS that adds important perspectives to treating breast cancer patients and showing that some patients may be able to de-escalate treatments and still have positive outcomes," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. "Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients. We are pleased to see authorities expanding access to this test as we continue to develop key evidence in collaboration with some of the world's most prestigious, breast cancer-focused organizations."

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.

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.


Clarius Awarded Technology Breakthrough Designation in Ultrasound Category with Premier, Inc.

Clarius specialized wireless ultrasound scanners now available on national group purchasing agreement to over 4,350 Health Systems and Hospitals and 300,000 other healthcare providers.

BD Launches Advanced Vascular Access Ultrasound System Designed to Improve Clinician Efficiency

The SiteRite™ 9 Ultrasound System is an all-in-one system designed with a user-friendly experience on an updated 15.6-inch touch screen with enhanced image quality that provides industry-leading catheter placement tools and technologies to support clinicians during the vascular access device insertion process. The system includes integrated visualization tools such as the Cue™ Needle Tracking System to provide nurses with continuous and real-time needle tracking, and the Sherlock 3CG+™ Tip Confirmation System to ensure proper catheter tip navigation and location.

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.


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!

Jeff Anderson Appointed New CEO at Nutjobs Inc.

"We are excited to welcome Jeff Anderson to Nutjobs as our new CEO. His broad experience and tactical leadership will be instrumental in executing against our vision to provide innovative, sustainable solutions to our customers," said Paul Kephart, Co-Founder, Chief Technology Officer and Chairperson of the Nutjobs Board.

Potrero Medical Announces Restructuring and Continued Operations

Potrero Medical believes that this voluntary reorganization will bolster its finances and facilitate its ongoing focus on elevating patient care.

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.

Market Reports

Filter Needles Market Size, Share & Trends Report 2023-2030: Global Analysis by Raw Material (Stainless Steel, Glass), and End-use (Hospital, Clinics, Ambulatory Surgery Centers) –

The "Filter Needles Market Size, Share & Trends Analysis Report By Raw Material (Stainless Steel, Glass, Others), By End-use (Hospital, Clinics, Ambulatory Surgery Centers, Others), By Region, And Segment Forecasts, 2023 - 2030" report has been added to's offering. The global filter needles market size is expected to reach...

Global Pain Management Drugs and Devices Market Report 2023 – Rising Demand for Minimally Invasive Pain Solutions –

The global market for pain management drugs and devices was valued at $80.9 billion in 2022. The market is estimated to grow from $84.6 billion in 2023 at a compound annual growth rate (CAGR) of 5.4% to reach approximately $109.9 billion by the end of 2028. This report segments the global market by product, application and region.

Global Medical Imaging Equipment Services Market Report 2023-2030: Rise in Third Party Imaging Centers Result in Increased Demand for Timely Servicing –

The global market for Medical Imaging Equipment Services estimated at US$20.9 Billion in the year 2022, is projected to reach a revised size of US$29.7 Billion by 2030, growing at a CAGR of 4.5% over the analysis period 2022-2030.

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.


Karolinska University Hospital Signs Memorandum of Understanding with 2 Hospitals in Ukraine

To increase the exchange and support to healthcare in Ukraine, Karolinska University Hospital has signed a Memorandum of Understanding with the hospitals Kryvyi Rih City Clinical Hospital in Kryvyi and Ohmatdyt National Specialized Children's Hospital in Kyiv.

Newly Unveiled Verstandig Pavilion at MedStar Georgetown University Hospital Promises Continued World-Class Care in a World-Class Facility

"As we built the Pavilion, we had one foot in today—building a facility that reflects the full capabilities of medicine today, and one foot in tomorrow—building a facility with comprehensive flexibilities, so that as medicine continues to evolve we will be able to meet the healthcare needs of our region for decades to come," said Kenneth A. Samet, president and chief executive officer of MedStar Health.

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.


Fiber Lasers: Pioneering Solutions For Complex Medical Challenges

This article dives into the distinctive traits that fiber lasers possess to enable contemporary therapeutic and diagnostic breakthroughs.

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.

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...

Nurses Corner

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...

Articles of Interest

Toasty Heater Reviews For Sale, Price 2023 SCAM NEWS! Portable Heater

The Toasty Heater offers an easy installation method, which means you can start enjoying its benefits right away...

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,...

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