Friday, September 29, 2023
Friday, September 29, 2023
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Medical Device News Magazine, is a digital publication founded in 2008 and located in the United States. Our publication is one of the most trusted sources of information for the medical device and biotech industries, providing timely and accurate updates to professionals and enthusiasts alike. With 24/7/365 accessibility, our magazine is the perfect solution for anyone looking for a fast, easy read on the latest industry news. Stay informed with Medical Device News Magazine – your one-stop source for biotech and medical device industry updates.

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Featured News

Ariceum Therapeutics’ Targeted Radiopharmaceutical 177Lu-satoreotide Exhibits Promising Clinical Response and Good Tolerability Profile in Patients with Advanced Neuroendocrine Tumours

Satoreotide combines Ariceum’s proprietary peptide satoreotide - a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SSTR2) - with the radioactive isotope ‘payload’ 177Lutetium. SSTR2 is a cell surface protein often overexpressed in certain cancers, including NETs and small cell lung cancer (SCLC).

New Hot Start Isothermal Mixes Boost Sensitivity, Specificity, and Speed of DNA Target Detection

Isothermal mixes are important in a range of isothermal amplification applications, including whole genome amplification, point-of-care assay development and testing, and strand displacement amplification for synthetic biology. However, a common issue with isothermal mixes is non-specific amplification — where primers bind to unintended DNA targets — because amplification often takes place at a fixed temperature which may favour non-specific primer interactions, contrary to PCR. Isothermal mixes can also lead to primer dimer formation, where primers associate with each other and are extended by the polymerase.

Branded Legacy Invests Heavily in Innovation and Growth with $540,000 Expansion

This strategic initiative underscores Branded Legacy's unwavering commitment to innovation, quality, and customer satisfaction. The expansion project is set to infuse over $500,000 worth of inventory into the company, reinforcing its position as a leader in the market.

Cue Biopharma Completes Patient Enrollment in Ph1b Head & Neck Cancer Trial

“Completing the enrollment of the recommended phase 2 dose patient expansion cohort is an important milestone as the data from this trial guides further development plans and associated discussions with the Food and Drug Administration (FDA),” said Daniel Passeri, chief executive officer of Cue Biopharma.

Revvity Expands Access to Base Editing Technology with Aim to Accelerate Discovery to Cure

Michelle Fraser, head of cell and gene therapy at Revvity, underscores the importance of providing broad access to this technology: "Base editing has been extensively demonstrated in numerous studies to safely and precisely control the correction of single base changes at multiple target sites, simultaneously. This streamlined approach simplifies complex multi-gene editing, holding great promise for the development of new cell therapies targeting rare inherited genetic diseases, cancer, and in the creation of universal donor cells as the foundation of allogeneic cell therapies."
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RaySearch Receives Order for RayStation and RayCare in Italy

The order includes implementation of both RayStation and RayCare at C.R.O. Aviano. The combination of RayStation and RayCare provides an integrated and unified solution throughout the complete workflow, when combined with an IBA proton therapy machin

Microban and Cleanwaste Medical Unveil the new Sani-Bag+ with Built-in Antimicrobial Technology

The Sani-Bag+ has been meticulously designed and engineered with Microban technology to address the pressing need for clean and user-friendly disposable commode and bedpan liners in healthcare settings.

At PDA Universe of Pre-Filled Syringes, Schreiner MediPharm to Introduce Freeze-Light-Protect Label

The Freeze-Light-Protect syringe label combines light protection with viability at temperatures well below zero. The new solution is particularly relevant for sensitive mRNA-based substances as well as cell and gene therapies.

Kepler Vision Technologies Unveils Innovative Kepler Night Nurse Lying Position Detection to Combat Pressure Ulcers

The Kepler Night Nurse Lying Position Detection augments the existing suite of features, including fall detection and prevention modules. This new addition is designed to empower healthcare professionals in their tireless efforts to prevent and mitigate the occurrence of bedsores.

ZAP Surgical Announces Upcoming Installation of Next-Generation ZAP-X Gyroscopic Radiosurgery in Ankara, Turkey

Hacettepe University Hospital is among the highly esteemed Turkish institutions on the international platform and holds a leading position in medical education. Hacettepe has become the preeminent healthcare center of Turkey and proudly serves as a major training center for Hacettepe University Faculty of Medicine students and residents.
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Clinical Trial Updates

Theradaptive Awarded DOD Clinical Trial Award of up to $7.4 Million

Commenting on the award, Theradaptive CEO and founder, Luis Alvarez, Ph.D. said, "The CDMRP Clinical Trial Award comes at a pivotal time for our company as we prepare for first in human clinical trials. Veterans and service members are disproportionally likely to suffer from traumatic extremity injuries or spinal degeneration and disc injury, and currently lack efficacious treatments with very few options. We have already demonstrated superior outcomes in preclinical studies, showing the promise of our technology. With this CTA award we are one step closer to providing new and improved therapies to patients and aligning with CDMRP's strategic goal of trying to increase post-injury quality of life by halting or slowing orthopedic disease progression in servicemembers and veterans."

Theradaptive Awarded DOD Clinical Trial Award of up to $7.4 Million

Commenting on the award, Theradaptive CEO and founder, Luis Alvarez, Ph.D. said, ‘The CDMRP Clinical Trial Award comes at a pivotal time for our company as we prepare for first in human clinical trials. Veterans and service members are disproportionally likely to suffer from traumatic extremity injuries or spinal degeneration and disc injury, and currently lack efficacious treatments with very few options."
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Imaging /Ultrasound

Fujitsu and iSurgery Launch Bone Health Promotion Project in Japan with Jikei University School of Medicine Aiming for Early Detection of Osteoporosis

In this demonstration, the project group will utilize iSurgery's AI medical device, the medical image analysis software Chest Bone Indicator (3) (AI medical device), to assess bone health from chest radiographs and notify the results of health examinations for Fujitsu Group employees.

Combining best-in-class AI-powered Technologies for Musculoskeletal (MSK) Imaging Workflows – ImageBiopsy Lab and Radiobotics sign Collaboration Agreement

Dr. Richard Ljuhar, CEO and Co-Founder of ImageBiopsy Lab, explains, "Before even considering the use of AI, it's crucial to grasp physicians' diagnostic workflow and needs. For this purpose we've closely collaborated with leading MSK radiologists, orthopaedics, and traumatologists over the past years. We're committed to revolutionizing the entire MSK diagnostic value chain for practitioners, patients, and healthcare systems.

Lunit’s AI-Powered Mammography Analysis Solution Achieves Comparable Diagnostic Performance with Human Readers

"This first study to apply the Personal Performance in Mammographic Screening (PERFORMS) scheme to AI algorithms marks a remarkable achievement, showcasing our AI's ability to match human performance in detecting breast cancer. It offers hope to patients worldwide and underscores AI's potential to enhance cancer detection and treatment outcomes," said Brandon Suh, CEO of Lunit.
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Industry Executives Views & Opinions

A Platform Approach: Expanding a Molecular Diagnostic Device Beyond Human Applications | By Shaun Holt, CEO, Alveo Technologies

Holt writes, "Avian flu is a global crisis, and not just for the poultry industry. There are serious potential implications for human health as well. But, let’s start with agriculture. Some strains of avian flu can be highly pathogenic. Once a single bird shows symptoms the clock starts ticking — it’s not unusual for an entire flock of tens of thousands of birds to die within two to three days."

The Hollywood Writers’ Strike and Ethical AI | By Ed Watal, Founder & Principal — Intellibus

Watal writes, "Less than 12 months ago, with the debut of AI-powered ChatGPT, the true power of AI hit the mainstream. Since then, it has established an unshakeable belief in everyone’s minds that artificial intelligence is here to stay and will forever alter a number of industries." What do you think? Read on.

Viraj Gandhi On Automation and Technology – to Drive Progress in Pharmaceutical Manufacturing

This article takes a closer look at the key benefits of automation and technology in pharmaceutical manufacturing and how Medivant Healthcare harnesses these solutions to drive progress across our production facilities. Read what Viraj Gandhi has to say.

Limb Loss and Preservation Registry (LLPR) Transforms Care Through Data and Insights | By Shawn Murphy, Vice President, Thought Leadership & Innovation Foundation (TLI)

Shawn Murphy writes, "The Limb Loss and Preservation Registry (LLPR) represents a pivotal development in patient care. It stands as the first collaborative database that unites hospital and health systems, provider organizations such as Accountable Care Organizations (ACOs), Integrated Delivery Networks (IDNs) and orthotic/prosthetic (O&P) practices, focusing on both upper and lower extremity acquired and congenital limb differences, as well as limb preservation populations. This collective effort has the potential to drive substantial advancements in patient outcomes, treatment effectiveness and care quality." Read to learn more.

It Takes an Ecosystem – Bringing Stakeholders Together is a Critical 1st Step to Solving Problems In Healthcare | By Andrew Cleeland, CEO, Fogarty Innovation

Andrew Cleeland writes, "Introducing a new medical therapy or technology is a complex, expensive, and time-consuming journey, one that is fraught with significant risk. While innovation often starts with a clear, well-defined unmet clinical need, it must be paired with an equally compelling value proposition. My mentor, Dr. Thomas Fogarty, once said, “An idea, by itself, has no importance whatsoever; it is the implementation of that idea and its acceptance by others that brings benefit to our patients.” Read on.

Chemotherapy Starts With Scalp Cooling Treatment: The Path to Improved Access | By Claire Paxman, Director of Global Training of Paxman

Paxman writes, "When Real Housewives of Miami star Guerdy Abraira recently proclaimed “Chemo Starts Now” after shaving off her hair before starting her treatment for breast cancer in People Magazine1, this made me realize just how little the general public and even celebrities like Abraria know about the medical technology being utilized today, such as scalp cooling systems, to manage and prevent chemotherapy-induced hair loss." Read to learn more.
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Mergers / Acquisitions

Varian Acquires Aspekt Solutions, Strengthening Advanced Oncology Solutions Offering

"Through our AOS offerings, we've been leading the way in melding innovative technology with clinical expertise to help address these challenges," commented Chuck Lindley, Vice President of AOS, at Varian. "With Aspekt Solutions, we can support more oncology centers with a holistic approach to addressing today's challenges while also preparing for the fast-evolving future of cancer care."

Sharps Technology Signs Asset Purchase Agreement to Acquire InjectEZ Specialty Copolymer Syringe Manufacturing Facility and a 10-Year Purchase Agreement for Over $400 Million from Nephron Pharmaceuticals

“These transactions represent a transformative event for the Company,” commented Soren Christiansen, Board Chairman of Sharps Technology. “Recruiting Robert Hayes as our CEO two years ago was a substantial achievement for Sharps Technology and its shareholders. Robert has built a strong team, and together they worked through a successful, multi-month financing process that resulted in selecting a funding partner that is poised to provide up to $75 Million in debt financing to be used for the transaction.

Boston Scientific Announces Agreement to Acquire Relievant Medsystems, Inc.

″We anticipate this novel, clinically-backed technology can support our category leadership strategy while expanding access to care for individuals who need personalized treatment,″ said Jim Cassidy, president, Neuromodulation, Boston Scientific. ″Upon close, we look forward to working with the Relievant team to explore opportunities to bring this high-growth therapy to a wider population of people living with chronic low back pain.″
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GROWTH / DEVELOPMENT

Laverock Therapeutics Raises £13.5M

Laverock Therapeutics notes the funding will enable further development of the GEiGS technology and progression of Laverock’s programs in regenerative medicine and immuno-oncology, with a focus on Type I Diabetes and solid tumor responsive T-cell and macrophage-based immune therapies, through to in vitro and in vivo validation.

SpineX Receives NIH SBIR Phase II Award for SCiP Clinical Trial in Children With CP

These funds will go towards completing a pivotal clinical trial to test the efficacy and safety of our proprietary SCiP™ device in children living with Cerebral Palsy (CP) notes SpineX.

Summus Raises $19.5 Million

Fundraise supports market expansion with Summus emerging as the premier clinical platform to share and access high quality specialty expertise across the continuum of care — serving employers, payers, health systems and physician groups.
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FDA

4SC Receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby.  We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”

Abyrx Receives FDA Clearance for MONTAGE ® Settable Bone Putty for Use in Cardiothoracic Surgery

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.
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Executives on the Move

CorWave Appoints Magalie Durrèche as Chief Financial Officer

Magalie Durrèche will oversee the financial management and participate in the strategic planning and fundraising of CorWave, a company developing and manufacturing a blood pump based on breakthrough technology. She succeeds Zina Hamoumi, who served as Chief Financial Officer for five years before deciding to focus on other projects.

Veracyte Names Dr Phillip G Febbo Chief Scientific Officer and Chief Medical Officer

“Phil G Febbo is an exceptional leader with a strong track record of driving successful commercialization of molecular tests through evidence development, guideline inclusion and key opinion leader support,” said Mr. Stapley. “His experience and expertise will be critical to further enhancing our ability to serve our customers and, ultimately, to transforming cancer care for patients all over the world.”

GrayMatters Health Expands US Executive Team, Including Appointment of Dr Aron Tendler as Chief Medical Office

Dr Aaron Tendler is a board-certified psychiatrist based in Palm Beach, Florida, bringing over 20 years of experience as an industry leader researching novel treatments for mental health disorders.
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Market Reports

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Medical Device Summit

Noteworthy

How Has Technology Helped to Improve Accessible Products?

Maximizing Healthcare IT Consulting for Streamlined Operations

Air Purifiers In Healthcare: Enhancing Indoor Air Quality

Scaling Up Your Restaurant Business with Restaurant POS Software

The Secrets of Dental Office Upgrades: 6 Tips for a Thriving Practice

How To Conduct Controlled Medical Research In A Lab

Impact of Technology on Medical Advancements

Seeing the Unseen: How Spectrometers Shape Our Scientific World

Unraveling Cloud Migration: A Comprehensive Guide for Modern Enterprises

How Can Online Exam Software Improve CPR Training and Certification?

The Importance of Employee Development Plans for Your Company and Staff

5 Eye-Catching Graphic Elements To Include in Your Next Business Proposal

5 Ways Public Health Experts Can Enhance Medical Device Safety

How to Ensure Your Website Is ADA Compliant and Accessible

Mastering the Art of Learning: Proven Techniques for Success

Is Doing a Master’s in Public Health Worth It?

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PHYSICIAN / MEDICAL EDUCATION / MARKETING

Impact of Technology on Medical Advancements

Technology has greatly improved medical services and made significant changes in how doctors help people stay healthy. Are you wondering- how? Nowadays, experts can make fake bones and organs with...

What Are the Top Skills Every Future Doctor Needs to Perfect?

Becoming a doctor is a noble and challenging pursuit. It's a profession that requires a unique blend of scientific knowledge, technical skills, and human empathy. As medical science advances...

Systematic Education for Sedation: A Guide for Hospital Leaders

Sedation is a vital procedure in patient treatment and care. When appropriately done, it enables patients to tolerate medical procedures more comfortably by reducing the perception of pain, agitation,...

Community Care Impact: Making A Difference With Doctor Jobs

The medical field constantly undergoes transformation, and doctors are pivotal in spearheading these changes, from technological advancements to evolving patient care standards. However, community care impact often remains underappreciated...

Nurses Corner

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Association News

CEUS Underutilization May Pose Greater Risk Than Rare Side Effects Associated With Use, Say Experts

The conference drew CEUS experts from North America, Europe, China and Brazil, and focused on advances in the use of “microbubble” ultrasound enhancing agents (UEAs) used routinely worldwide to diagnose heart and vascular disease, identify and characterize tumors, monitor chronic gastro-intestinal diseases, evaluate other serious medical conditions and monitor therapy. UEAs do not contain dye, create no known risk of kidney damage or deposit of contrast media in the brain, and do not expose patients or hospital staff to ionizing radiation.

Society for Vascular Surgery Foundation Launches September Vascular Health Step Challenge During PAD Awareness Month & Healthy Aging Month

The Society for Vascular Surgery Foundation invites the community to join our September Vascular Health Step Challenge and quite literally take steps toward better vascular health," says Dr. Joseph Mills, SVS President. "PAD affects more than 10 million people in the U.S., but walking an average of 30 minutes or more each day can lower the risk of PAD. Together, we're working to raise awareness, raise our step counts, and raise vital funds to help low-income PAD patients."
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Health

Responsible Drinking

Staying Within the Limits: 7 Tips for Responsible Drinking

Ptsd

Therapy & Counselling: How It Helps to Deal with PTSD?

Tooth Decay

The Aesthetics And Health Implications Of Tooth Decay

Counseling

7 Reasons to Give Counseling a Try

Money Affects Your Well-Being

The Health & Wealth Connection: How Money Affects Your Well-Being

Hair Replacement Systems For Men

The Modern Solution for Hair Loss – Hair Replacement Systems for Men

Teacher Well-Being

7 Tips for Managing Teacher Well-being

Face To Face Interaction

The Power of Face to Face Interaction You May Not Realize Exists

Sherief Abu-Moustafa’s Approach To Fostering An Intergenerational Dialogue On Mental Health

Breast Augmentation

5 Common Questions About Breast Augmentation

98 9

4 Early Signs and Symptoms of Diabetes

Mycosoothe Reviews

MycoSoothe Reviews: PhytAge Labs SCAM or Legit Supplement for Toenail Fungus?

Yummy Slim

Yummy Slim Höhle Der Löwen Erfahrungen – Yummy Slim Bewertungen, Test, Einnahme, inhaltsstoffe, DM Bei Rossmann Kaufen

Friend Groups

How Expanding Your Interests and Friend Groups Can Be Beneficial for Your Health

Healy

The Family Tree with Healy: Reconnecting with Our Roots

Compounding Pharmacy Benefits

7 Reasons Why a Compounding Pharmacy May Benefit You

Good Oral Health

Keep Your Teeth Healthy and Avoid Major Dental Work

Psychological Assessments Arlington Va

The Benefits of Psychological Assessments in Arlington, VA

Regular Visits To Your Physician

6 Reasons to Maintain Regular Visits to Your Physician

Nursing Home For Your Aging Parents

How to Choose a Nursing Home for Your Aging Parents

Cardioflex Reviews

CardioFLEX Reviews: Is it Legit and Safe to Use? What Customers are Saying!

Sonic Serene Tinnitus Drops Reviews

Sonic Serene Tinnitus Drops Reviews (SCAM or LEGIT) Fake Hype Exposed

Wellme Biovanish Reviews

WellMe BioVanish Reviews (Legit or Fake Results) What Customers Are Saying?

Actiflow Reviews

ActiFlow Reviews (FAKE Hype Exposed) Is it Legit and Safe Prostate Supplement?

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Articles of Interest

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