A facility that treats its supply chain as a strategic function, rather than a recurring purchase order, is better positioned to maintain the consistent standard of care that patients and staff depend on every single da
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Medical Device News Magazine is committed to delivering high‑quality, in‑depth medical device news and biotechnology updates that include expert bylines. Our coverage offers a comprehensive view of the trends, innovations, and breakthroughs shaping the future of medical technology.
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Latest Developments, Breakthroughs & Future Outlook
The Valgen Medtech DragonFly™ System Receives EU Approval for FMR Indication
To date, DragonFly™ has received regulatory approvals in 15 countries and regions, with routine clinical use and commercial adoption already underway in key international markets including Latin America and Southeast Asia
Corvention Announces First Case in the U.S. and Initiates Limited Commercial Launch of Innovative Balloon Catheter
The milestone procedure was performed by world-renowned interventional cardiologist Alan Zajarias, MD, in St. Louis, Missouri.
Tecan accelerates Data-Driven Lab journey with Agentic AI developments powered by NVIDIA
A milestone in the collaboration announced in March 2026, this Agentic AI development demonstrates advancement of Tecan and NVIDIA’s shared vision of enabling Data-Driven Laboratories with AI-powered platforms designed to accelerate scientific discovery and improve laboratory productivity
Clinical Trials
Raydiant Oximetry Completes Enrollment of First 15 Patients in IDE Pilot Study at LSU Health Shreveport
Michael Nagel, Chief Executive Officer of Raydiant Oximetry. "The FDA's authorization to expand enrollment is an important milestone for the program. We look forward to continuing our collaboration with LSUHS as we build the clinical and technical foundation for an entirely new generation of fetal monitoring technologies."
Paragonix Technologies Announces Launch of CONCERT-DCD Clinical Trial in Collaboration with UW Medicine to Maximize Heart Transplant Utilization
Prospective, multicenter trial will evaluate a novel preservation technique utilizing the Paragonix SherpaPak® for DCD (Donation after Circulatory Death) hearts
Combat Medical highlights patient impact of HIVEC HEAT trial at the American Urological Association Annual Meeting
The ongoing HIVEC HEAT trial aims to generate clinical data to evidence the efficacy of hyperthermic intravesical 80mg mitomycin C chemotherapy for patients with BCG-unresponsive, high risk NMIBC
Biotechnology News
HKeyBio Launches NHP Fast-Tox Program for Accelerating Non-GLP NHP Safety Risk Screening
The program supports early tolerability assessment, PK/TK-linked safety evaluation, immune-related risk screening, and pre-GLP dose design for biologics and immunomodulatory drug programs
ALZpath Signs Global Licensing Agreement with Abbott to Advance Blood-Based Alzheimer’s Disease Testing
"This agreement further strengthens ALZpath's leadership in blood-based Alzheimer's testing and reinforces our position as the foundational component supporting the overwhelming majority of the pTau217 IVD market," said Mike Banville, CEO of ALZpath.
Spotlight Medical Secures IVDR CE Marking for myStage Dx, Its AI-Enabled Prognostic Test for ER+/HER2 – Early Breast Cancer
Class C software-only IVD supports European rollout of a JCO-published assay designed to bring clinically validated prognostic assessment into routine breast cancer care
CellxLife Secures Exclusive License for Dendritic Cell Vaccine Targeting Ovarian Cancer
CellLife notes the licensing agreement builds on their existing proprietary dendritic cell platform, which has demonstrated long-term durability in preventing relapse in pediatric patients with metastatic bone cancer in a Phase I clinical study conducted at leading institutions in Europe
Mergers & Acquisitions
Medtronic completes acquisition of Scientia Vascular, seamlessly integrating access and therapeutic portfolios for neurovascular care
Acquisition delivers simplicity and access, supporting physicians across the full procedural workflow
Otsuka Completes Acquisition of Transcend Therapeutics to Advance Next-Generation Neuropsychiatric Treatments
The acquisition will expand Otsuka’s continued investment in emerging, next-generation neuropsychiatric treatments for serious mental illness
Ernest Health Acquires Reunion Rehabilitation Hospitals, Expanding National Network
Upon completion of the transaction, Ernest Health will expand its footprint from 38 to 45 medical rehabilitation hospitals across the United States
Funding
Auxilium and MBI Announce First Accelerator Cohort, Investing $1 Million Across Four Life Science and Healthcare Startups
Through the program, Auxilium will invest a total of $1 million across the cohort, with each company receiving a $250,000 investment to help accelerate growth beyond early validation
Ingenix Raises €13m From Sofinnova Partners-Led Syndicate to Scale Modality Fusion, a Novel Architecture for Drug Development
Ingenix's Biological Reasoning Engine fuses biological data through Modality Fusion, a new architecture for AI in drug development
Advanced NanoTherapies Secures Over $31M Series B to Deliver First-of-its-Kind Dual-Drug (Paclitaxel and Sirolimus) Nanoparticle-Coated Balloon Platform for Vascular Treatment
Financing supports the approval of U.S. Investigational Device Exemption (IDE), coronary clinical advancement, and expansion into below-the-knee peripheral (BTK) applications
Bylines by the Experts
While many regenerative treatments rely on injections administered in specialized clinics, his cream is designed to offer a non-invasive alternative
iotaMotion Receives FDA Clearance for Expanded Pediatric Use of iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System
As part of this milestone, Cincinnati Children’s Hospital, a nationally ranked pediatric medical center, and U.S. News & World Report Honor Roll member for 2025–2026, has become the first dedicated pediatric center to adopt the iotaSOFT Insertion System.
January 14, 2026
FDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen DeficiencyFDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen Deficiency
The 2-gram single-dose bottle joins the existing 1-gram version, giving clinicians more options for streamlined dosing and reconstitution in urgent bleeding scenarios
January 7, 2026
Executives In the News
Dr Katerina Leftheris Is Appointed to the Board of Directors at Enhanced Genomics
Experienced leader in preclinical and clinical drug development will support expansion of Company’s therapeutics pipeline for complex and common genetic diseases
January 9, 2026
Marshall Mohr Joins Capstan Medical Board of Directors
“Capstan’s platform is tackling an unserved area of cardiovascular care for a patient population that has almost no other options,” said Mohr. “It has the potential to transform heart valve disease for patients at high risk for surgery, into a precise, and low-stress procedure for both patients and clinicians.”
January 7, 2026
VALANX Biotech establishes Board of Directors
Renowned industry leaders, Michael Boehler, Alexander Schwartz, Urs Spitz and Ingo Nagler, appointed to guide strategic and commercial development
December 9, 2025
Byron Jobe Recognized as One of Modern Healthcare’s 100 Most Influential People in Healthcare
This prestigious recognition program acknowledges and honors individuals who are deemed by the Modern Healthcare newsroom to be the most influential figures in the industry in terms of leadership and impact
December 8, 2025
Advancements In Imaging
Catalyst MedTech Secures Exclusive U.S. Distribution of CareMiBrain™ PET System with NeuroQ4™, Showcasing a complete Neurologic PET Solution at SNMMI 2025
This milestone marks a powerful collaboration between Catalyst MedTech and OncoVision, reinforcing our shared commitment to expanding access to advanced neurologic imaging across the U.S.
June 20, 2025
Isotopia and Cardirad Announce Launch of Isoprotrace ® in Sweden and Denmark, Expanding Access to Advanced Prostate Cancer Imaging
The introduction of Isoprotrace® into these Nordic markets marks a significant step forward in expanding access to precision diagnostic tools for prostate cancer.
May 30, 2025
Hyperfine Announces FDA Clearance of Optive AI™ Software, Introducing the Most Substantial Image Quality Improvement Ever for the Swoop® System
Latest Swoop® System software delivers a substantial leap in image quality for AI-powered portable MR brain imaging.
May 28, 2025
Philips Launches RADIQAL Study to Generate Real-world Evidence for New Ultra-low X-ray Dose Technology in Coronary Procedures
This multicenter, randomized study, sponsored by Philips will enroll 824 coronary artery disease patients across 6 hospitals in Spain, Czech Republic and the US. The first patient in the study was enrolled at Aarhus University Hospital, Denmark.
May 20, 2025
Hospitals In the News
S.L. Raheja Hospital, Mumbai Completes 50 TAVI Procedures, Showcasing Excellence Minimally Invasive Heart Solutions
This milestone puts S.L. Raheja Hospital, Mahim, at the forefront of cardiac care in Mumbai, with one of Mumbai’s most advanced Structural Heart Programs.
May 28, 2025
Delray Medical Center Acquires Intuitive da Vinci 5 Surgical System
Da Vinci 5 is the newest entry to the da Vinci portfolio of systems, which also includes da Vinci X®, da Vinci Xi®, and da Vinci SP®. The system can be used for minimally invasive surgical procedures for urology, gynecology, thoracic, and general surgeries.
May 9, 2025
Adventist HealthCare Emergency Departments Launch AI Initiative to Help Enhance Patient Safety and Care Efficiency
The software, KATE AI, is helping care teams ensure the safety and consistency of triage at Adventist HealthCare Shady Grove Medical Center, Adventist HealthCare White Oak Medical Center and Adventist HealthCare Fort Washington Medical Center. Emergency teams at the hospitals are using KATE AI to help verify care plans for patients who are at higher risk or have more complex conditions.
April 22, 2025
Delray Medical Center Notes Vascular Surgeon Dr Joseph Ricotta 1st in the World to Utilize the Celt ACD PLUS System In a Procedure
“The Celt ACD PLUS is another surgical option for patients, ensuring that they have the best chance of a good outcome,” said Dr. Ricotta. “By investing in the latest medical technology, we remain at the forefront of innovation as medicine continues to advance.”
Dr. Ricotta is the National Medical Director of Vascular Surgery and Endovascular Therapy for Tenet Healthcare, and Professor of Surgery and Founder and Program Director of the Vascular Surgery at Florida Atlantic University’s School of Medicine.
March 27, 2025
Non-Profit Association News
National Scoliosis Center Focuses on Non-Surgical Curve Improvement for National Scoliosis Awareness Month
New research presented at the 2026 SOSORT International Congress in Italy demonstrates the power of custom 3D bracing and consistent patient care
NMDP Celebrates Public-Private Partnership with HRSA in Expanding Patient Access to Life-Saving Bone Marrow and Cord Blood Transplant
Nonprofit reaches milestone of facilitating 150,000 transplants giving patients a second chance at life, thanks to federal investment in and Congressional commitment to the C.W. Bill Young Cell Transplantation Program
AHF Reports: Ebola Crisis Exposes Failure of Current Global Health Architecture
The current outbreak involves the Bundibugyo strain of Ebola virus, for which no approved vaccines or therapeutics currently exist, heightening concerns among global health officials and frontline responders, according to reporting by Health Policy Watch
Healthcare: Understanding the Business Site of the Healthcare Industry and Its Implications
Why HPLC Uptime Decides Whether Your Device Release Testing Ships on Time
More extractables work as combination products grow, more scrutiny on data integrity, more pressure to ship validation packages faster. So here's the question worth sitting with: when your next 510(k) or PMA hinges on a column of impurity data, do you actually know whether the instrument that generated it is still performing...
How Smarter Pharmaceutical Warehousing and Distribution Ensures Medical Safety
A secure and efficient supply chain is essential for the delivery of safe medical treatments. By prioritizing environmental controls, total traceability, and strict fulfillment accuracy, specialized logistics providers ensure that vital medications remain safe and effective
The Google Listing Most Plastic Surgeons Set Up Once and Never Touch Again — And What It’s Costing Them
Learn how plastic surgeons can optimize their Google Business Profile, improve local search rankings, attract more patients, and grow their practice online
Careers In Healthcare
HomeCEU Introduces New OT Grad Toolkit to Support Occupational Therapy Graduates Looking for Jobs in the Healthcare Industry
This employment toolkit is designed to walk a new occupational therapy (OT) graduate through the process of landing their first job in healthcare
How to Evaluate the Quality of a Graduate Business Program
Choosing a graduate business program today is not just about prestige. It is about outcomes, flexibility, and relevance in a world shaped by AI, remote work, and economic uncertainty.
How Education Can Open Doors in Healthcare Professions
Education is more than a requirement in healthcare; it is the key that unlocks opportunity, stability, and purpose.
Nurse's Corner
Accelerated BSN Programs: A Swift Solution to the Nursing Shortage
Accelerated BSN programs offer a rapid pathway into nursing for those with prior degrees and these programs help address the nationwide nursing shortage by quickly preparing qualified professionals.
Nurse Burnout: A Strategic Threat Hospitals Can’t Afford to Ignore
Burnout isn’t just “being tired.” It’s a chronic state of emotional, mental, and physical exhaustion caused by prolonged stress.
Nurses | How To In Shape
Many nurses manage to stay in great shape, both physically and mentally—despite the challenges
