Wednesday, October 4, 2023
Wednesday, October 4, 2023

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

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Featured News

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."

Edinburgh-based Med-tech Firm in MBO to Expand Into New Markets and Technologies

The acquisition will enable Novarum to build on its strong lateral flow test customer base and extend into adjacent markets. 

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.

Ordr Partners with e-Quip to Deliver Improved Connected Medical Device Visibility and Security for UK Healthcare Market

"Integra e-Quip is dedicated to making it easy for healthcare organizations to manage the myriad of medical devices they have connected to their networks. Doing this efficiently and effectively requires advanced visibility," said Dal Jdali, CEO, at Integra e-Quip.

Stryker’s Triathlon Tritanium Baseplate Marks a Decade of Positive Patient Impact

Marking its 10th anniversary, the Triathlon Tritanium baseplate is designed with Stryker Orthopaedic Modeling and Analytics (SOMA) and enabled by Stryker's proprietary additive manufacturing technology.

Medtronic Diabetes Announces CE Mark for New Simplera™ CGM with Disposable All-in-one Design

The company's newest Simplera™ CGM is 50% smaller than its previous generation with a simple insertion and improved user experience

AI Software Improves Endovascular Thrombectomy Treatment Times for Stroke Patients

The implementation of artificial intelligence-powered large vessel occlusion (LVO) detection software for acute stroke triage can improve endovascular thrombectomy treatment times, according to new research from UTHealth Houston.

Precision Dropper – The Next Revolution in Eye Health

Backed by a dedicated team and successful crowdfunding, Precision Dropper is rapidly transforming eye health across the world.

Relu® Reaches Medical Quality Standards with ISO13485 Certification

"This certification demonstrates our commitment to international quality and regulatory standards. Relu wants to build AI that people can trust." says Holger Willems, Co-Founder & CEO at Relu.

Mergers / Acquisitions

MedAlliance Acquired by Cordis for up to USD 1.135 Billion

MedAlliance has been acquired by Cordis for a 2022 investment of $35M and a 2023 upfront closing payment of $200M, together with regulatory achievement milestones of up to $125M and commercial milestones of up to $775M through 2029, for a total consideration of up to $1.135 Billion. 

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."

Clinical Trials and Updates

Amber Implants Announces Start of Clinical Trial with VCFix® Spinal System

This first-in-human clinical trial will assess the safety and effectiveness of the VCFix® Spinal System implant for patients suffering from vertebral compression fractures. The implant is provided with a user-friendly, single-use sterile surgical kit, ensuring perfect traceability and reducing the risk of infection. 

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."

Lipogems® Announces 140 Independent Peer Reviewed Publications with 5 Years of Follow up in Orthopaedics

Giorgio Ninzoli, President of Lipogems International. "The gold standard for evidence is 1 year follow up and we are excited to report 5 years follow up with positive results after a single injection of MicroFat."

Industry Executives Views & Opinions

Read What Our Medical Device News Experts Have to Say

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."


Akura Medical, a Shifamed Portfolio Company, Closes $35M in Series B Financing

Akura Medical reports the funds will be used to apply for FDA 510(k) clearance for the Akura Mechanical Thrombectomy Platform, support clinical trials for additional indications, and scale manufacturing capabilities.

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.


Phillips-Medisize Teams with GlucoModicum to Develop an Innovative Needle-Free Continuous Glucose Monitor

GlucoModicum is an innovative medtech company based in Finland, to design and eventually commercialize a proprietary non-invasive, wearable device that removes technology and patient-care roadblocks to continuous glucose monitoring (CGM).

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.


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.

Market Reports

Electrophysiology Catheters Market Size to Grow by USD 2.24 Billion from 2022-2027

The Electrophysiology Catheters Market size is expected to grow by USD 2.24 billion, accelerating at a CAGR of 8.73% during the forecast period, according to Technavio Research.

Endovascular Abdominal Aortic Aneurysm Repair Devices Market to grow by USD 697.78 Million from 2022-2027 | North America to account for 46% of market growth – Technavio

The endovascular abdominal aortic aneurysm repair devices market size is expected to grow by USD 697.78 million from 2022 to 2027. In addition, the momentum of the market will progress at a CAGR of 5.16% during the forecast period, according to Technavio Research

Global Ultrasound Probe Disinfection Market Research Report 2023-2027: Increasing Adoption of Automated High-Level Disinfection Systems Influencing growth

The "Ultrasound Probe Disinfection Market by Product (Instrument, Services, Consumables (Disinfectants & Detergents)), Probe Type (Linear, Convex, & TEE Transducers),Process (High-Level & Low-Level Disinfection), End User (Hospitals) - Global Forecast to 2027" report has been added to's offering.


Remote Patient Monitoring: Proven Best Practices for Small Clinics

Integrating this technology into your healthcare practice is essential to stay relevant and competitive. However, small clinics need to think beyond just providing a remote patient monitoring platform to their patients. You should take steps to maximize its benefits to streamline your processes and enhance patient care.

Embracing the Future of Care: Exploring the Top 7 Healthcare Software

The healthcare industry has evolved dramatically in the past few years. Thus, all medical providers aim to score an unrivaled place in the competitive healthcare landscape. They want to optimize clinical and financial outcomes. But it is not as easy as it sounds. If you think you can do so without going seeking assistance from healthcare solutions, you are in the wrong.

Adapting to the “New Normal”: Timur Yusufov Discusses Building Resilient Healthcare Services Post-Pandemic

Timur Yusufov explains the importance of developing resilient healthcare services post-pandemic and how this can be achieved with the right strategies and new technological advancements.

Principles and Applications of Amplicon Sequencing

Amplicon sequencing is a type of DNA sequencing technique commonly used to analyze a specific genetic region. This technique involves the amplification of a DNA fragment, or amplicon, using techniques such as PCR (polymerase chain reaction) to generate a large number of copies. Once these copies are made, they are sequenced to identify genetic variations or mutations. Amplicon sequencing is often used in research and clinical settings due to its high sensitivity and capability to analyze multiple specific regions simultaneously.

Association News

Challenges in Acute Heart Attack Care Continue Post COVID-19

According to a new study, presented at the American College of Cardiology (ACC) Quality Summit 2023, many health care facilities are still recovering from the pandemic and facing new challenges, causing D2B times to continue to lag.

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."

Combining AI Models Improves Breast Cancer Risk Assessment

Using mammography-based deep learning models may improve the accuracy of breast cancer risk assessment and can also lead to earlier diagnoses. 


Northwell Physician’s Research Nationally Recognized for Improving Radiation Therapy Quality

Leila Teodora Tchelebi, MD, a radiation oncologist at Northern Westchester Hospital and Phelps Hospital and an Associate Professor of Radiation Medicine at the Zucker School of Medicine, is one of the ROI’s three Publication Excellence Award Winners for 2023. The annual award recognizes the best scientific work in the field of radiation oncology. Dr. Tchelebi will accept the award on Oct. 1 at the American Society of Radiation Oncology annual meeting in San Diego.

St. Joseph’s Hospital Brings New Treatment for AFib to Central Florida

A new cryoablation procedure designed to improve treatment of paroxysmal atrial fibrillation (AFib) is being offered by St. Joseph's Hospital Heart and Vascular Institute in Tampa.

Bassett Healthcare Network Enhances Sign-On Bonuses for New Employees – Up to $35,000

Bassett Healthcare Network announced today it has significantly enhanced sign-on bonuses for a variety of open job positions for the next 90 days. Bonus increases took effect on October 1, including up to $35,000 for registered nurses.

Tampa General Hospital Named One of Newsweek’s Best Smart Hospitals for 2024

"As a leading academic health system, driving innovation is essential to our commitment to providing world-class care," said John Couris, president and CEO of Tampa General Hospital. "This recognition demonstrates our team's focus on adopting forward-thinking advancements in technology to maximize new approaches. The end result is better treatments and outcomes for patients now and long into future."

Physician / Medical Education

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 professional aspiring to a leadership role or a current leader looking...

Adapting to the “New Normal”: Timur Yusufov Discusses Building Resilient Healthcare Services Post-Pandemic

Timur Yusufov explains the importance of developing resilient healthcare services post-pandemic and how this can be achieved with the right strategies and new technological advancements.

Impact of Technology on Medical Advancements

When technology and medicine come together, it means that in the future, diseases will be found early and treated more effectively. Care for patients is getting better and better because of this vital relationship.

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...

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...

Healthcare Careers

Shock to Save: Explore the Critical Role of AEDs in Saving Lives

Every year, hundreds of lives are lost to cardiac arrests. It leaves people devastated and families shattered. The unpredictability of cardiac arrests emphasizes the urgent need for speedy and effective intervention. In such situations, the teachings of a CPR...

Shock to Save: Explore the Critical Role of AEDs in Saving Lives

Every year, hundreds of lives are lost to cardiac...

Maximizing Healthcare IT Consulting for Streamlined Operations

Some outside the information technology community fear that the...

Leech Therapy Demystified: What You Need to Know Before Training

For what may appear shocking to some, it has...

Is Pursuing a Professional Nutritionist Career Worth It?

Choosing a career is a pivotal decision that can...

An Easy Guide To Becoming A Dental Assistant

Dental assistants are one of the most important members...

What Options Are Available For a Career in Mental Health?

Mental health professionals are in-demand in multiple countries as...

Nurses Corner

Health / Lifestyle

Medical Device Summit

TerraCalm Does Really Work? BEWARE [Terra Calm] Fake SCAM Exposed Benefits & Side Effects Reviews

TerraCalm Reviews TerraCalm is a natural product from far abroad that has been particularly developed to give you rosy,...

How To Get Prescribed Modafinil For ADHD

In the world of ADHD (Attention Deficit Hyperactivity Disorder) management, the search for effective treatments can be a...

Can I Seek Treatment at An Urgent Care Facility If I Don’t Have Medical Insurance?

If you find yourself in need of medical care, but you don't have insurance, you may be wondering...

Medical Device Innovations: Transforming Mobility and Independence for Obese and Elderly Individuals with Specialized Chairs

Unlocking the power of independence and mobility is a universal goal, regardless of age or physical condition. For...

What Is Retinol? Facts About Its Uses, Benefits, & Side Effects

Who doesn’t want flawless skin? Everyone wants to keep their skin looking youthful for longer, and preserve their beautiful...

At-Home Remedies for Plantar Warts: Do They Work?

Plantar warts can be an uncomfortable and unsightly nuisance, making each step a painful ordeal. If you've ever...

Best Blood Sugar Supplements 2023: How to Lower Blood Sugar With These OTC Supplements?

Managing blood sugar is crucial for individuals with prediabetes or diabetes. In addition to conventional methods like lifestyle...

Best Prostate Supplement 2023: BPH Over the Counter Prostate Medicines That Work

Prostate health is a topic that often doesn't receive much attention from men until issues arise. However, taking...

Articles of Interest

The Pulse of Medicine: Top Medical News Stories

In our fast-paced world, staying informed about the latest developments in the field of medicine is not only...

Terminal Illness 101: Incorporating Funeral Planning Into Healthcare Choices

Facing a terminal illness presents a journey filled with emotions, thoughts, and considerations. A myriad of uncertainties unfolds,...

Effective Techniques That Will Make You a Better Version of Yourself Everyday

Everyone has dreams and aspirations for their future, but attaining them takes work. Sometimes in the daily struggle...

Dab Pen Vs. Lookah Bear Vape: A Vaping Comparison

Vaping has become a popular choice for many users seeking an alternative to traditional smoking. Two devices that...

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