Friday, December 8, 2023

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Medical Device News Magazine
Friday, December 8, 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

Cordance Medical Announces Agreement with Stanford Medicine’s Airan and Williams Labs for Precision Neuropsychiatry with Ultrasonic Drug Uncaging Technology

The combined expertise of Cordance Medical and the Airan and Williams Labs will see NeuroAccess utilized to deliver a novel application of drug-loaded nanoparticles, providing targeted drug delivery to the brain.

Graphene Nanotubes Revolutionize Protective Film Technology: Ultrathin, Permanently Conductive PSA

OCSiAl’s exceptional graphene nanotubes -based solution addresses these issues, ushering in a new era of silicone PSA technology. The user-friendly nanotube dispersion TUBALLTM MATRIX 617 results in excellent electrical conductivity combined with more than 90% transparency in a wide range of peeling-strength PSA films.

Medixine Continues Growth in the U.S.

Medixine prepares for 2024 with two key senior hires, VP of Operations in the U.S. and VP of Engineering in Finland. The appointments will enhance support and service to the company’s U.S.-based partners, including leading respiratory homecare provider Lincare and a major medical device manufacturer. In addition, the new hires will enable streamlined design, testing, and deployment of new product features for more patient-centric, cost and time-effective treatment of chronic conditions.

Optibrium’s Quantum Mechanics and Machine Learning Methods Predict Routes of Drug Metabolism

“Our latest study is the result of six years of focused research, delivering a practical model that allows users to predict metabolic pathways for a wide range of drug-like compounds. Thanks to our carefully curated datasets and our signature reactivity-accessibility approach, we have managed to build accurate isoform-specific regioselectivity models for the important Phase I and II enzyme families” Dr Mario Öeren, Principal Scientist, Optibrium said

Mergers / Acquisitions

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

Supercell, through partnerships in regenerative medicine, has secured an exclusive license for a Japanese-developed natural killer (NK) cell culture technique. The technique, pivotal in cancer cell elimination and immune system enhancement, will be showcased at the expo, highlighting their latest experimental advancement.

Funding

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

AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism

“The completion of the APEX-AV Study represents an important milestone in the catheter-directed therapies CDT space for the treatment of pulmonary embolism. I sincerely thank all the investigators for their commitment and dedication,” said William Brent Keeling, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate Past President, The PERT Consortium™.

Innovent Biologics and Synaffix Expand ADC Collaboration Following Positive Preliminary Clinical Signal from Ongoing Phase 1 Study

Innovent Biologics and Synaffix: Under the terms of the expanded agreement, Innovent will be responsible for the research, development, manufacturing and commercialization of new ADC candidates. Synaffix is eligible to receive an upfront payment plus potentialmilestone payments and royalties on commercial sales for each licensed target.

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."

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.

Imaging

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.

FDA

Ad Astra Diagnostics Receives 510(k) Clearance of QScout™ Hematology Analyzer

QScout ™ is the first hematology platform designed for simple, fast operation at the point-of-care. It provides lab-grade, patient-side results that caregivers use to screen for health conditions including infection, leukemia, and other blood-related cancers, allergies, and many more.

BD Receives FDA 510(k) Clearance for Potentially Transformative Fingertip Blood Collection Device

The BD MiniDraw™ Capillary Blood Collection System is less invasive than a traditional venous blood draw by using capillary blood collected from a patient's finger by a trained healthcare worker, without the need for a phlebotomist to collect blood from a vein.

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."

Executives on the Move!

Dr Charles R Gordon Joins Wenzel Spine as Executive Chairman

Dr Charles R Gordon was the founding Chairman of the Board for Baylor Scott & White's Texas Spine & Joint Hospital. Over the years the hospital has grown, and majority interest of the hospital was sold to Baylor Scott & White and United Surgical Partners International (USPI).

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.

Market Reports

ICU Beds Global Market Report 2024

The "ICU Beds Global Market Report 2024" has been added to ResearchAndMarkets.com's offering. The ICU beds market is set to grow from $2.02 billion in 2023 to $2.15 billion in 2024 at a compound annual growth rate (CAGR) of 6.9%. The growth observed in the historical period can be attributed...

Cardiac Bio Implant Devices Market Report 2023-2030

The "Cardiac Bio Implant Devices Market, Size, Global Forecast 2023-2030, Industry Trends, Growth, Share, Outlook, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering

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) – ResearchAndMarkets.com

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 ResearchAndMarkets.com's offering. The global filter needles market size is expected to reach...

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.

Hospitals

$25M Gift Spurs Transformative Research, Innovative Learning Environment at Sarasota Memorial Health Care System

The Kolschowskys, who live most of the year in Sarasota, Fla., have partnered with Sarasota Memorial Healthcare Foundation to support the Sarasota Memorial Health Care System's vision to create an innovative research and education environment that appeals to physician researchers and brings leading-edge treatments and specialists to the region.

St. Antonius Hospital to Deploy 2 Vitestro Blood Drawing Devices

Toon Overbeeke, CEO and co-founder at Vitestro, adds: "Our device is undeniably the biggest innovation in blood collection in decades, and will go a long way to solve the sharply increasing shortage of healthcare personnel. Since 2018, we are closely working with the enthusiastic and driven team at the St. Antonius hospital. It is exciting to now take the next step in our collaboration."

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 Verstandig 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.

Noteworthy

Analysis Of Labor Union Activities And Impact On Industries

Labor unions play a significant role in the modern workplace, representing the interests of employees and advocating for better working conditions. Eric Langston delves into the activities of labor unions and their impact on industries.

Future-Proofing Medical Labs

In the world of healthcare, staying ahead of the curve is not just savvy—it's essential. Sources within the industry are abuzz with the consensus that medical labs must bolster their readiness for the challenges ahead.

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.

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

How to Get Started On Your Weight Loss Journey

Losing weight can be a challenging and overwhelming task. Starting your weight loss journey involves changing your eating...

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...

Articles of Interest

A Must-Have Medical Equipment List For Ambulatory Care Facilities

Ambulatory care services provide a great alternative to hospital admissions. Instead of spending several days in medical facilities...

Life Heater Reviews – URGENT Customer Alert! Reviews 2023, Is It Really Effective Or Scam

The portable heating gadget begins heating by setting the temperature and time on the top knobs, and soon...

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...

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