- FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy’s Disease
- Sanofi Deepens Partnership with Medidata | To Expedite the Development of New Therapies with an Improved Patient Journey
- HOMELINK® Appoints Allan Schroeder as Vice President of Managed Care
- Invenra Inc. and Xcellon Biologics Announce Collaboration to Advance Bispecific and Trispecific Antibody-Drug Conjugate (ADC) Development
- Materna Medical Presents a Sub-Analysis Comparing Outcomes on a Spectrum of Menopausal Women, Showing Significant Improvements at Three Months
- MinXray to Showcase Collaboration, Art and Technology at the Union World Conference on Lung Health 2025
- Catalyst OrthoScience announces $15M in financing
Medical Device News Magazine is a digital Publication Founded in 2008, and proudly located in the United States
Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors. We take pride in offering high-quality, in-depth content, crafted by a team of experienced professionals. Our goal is to provide a unique perspective on the trends and innovations driving the future of medical technology. By reading our articles, you’re not only gaining exclusive industry insights but also becoming part of a community committed to advancing healthcare through groundbreaking technologies. Explore our content and consider partnering with us for advertising opportunities!
“Medical Device News: Essential Key Insights and Noteworthy Developments Shaping the Future”
4 Key Criteria for High-Precision Medical Materials
Material choice is inseparable from the manufacturing process and the partner who will make your parts at scale. By prioritizing the key criteria, you reduce risk and speed validation. Choose a partner to move from uncertainty to certifiable results
Which are the five best hospital equipment manufacturing enterprises in China that have obtained ISO13485?
Discover the leading hospital equipment manufacturing enterprises in China recognized for their ISO13485 certification and quality standards.
Monteris Medical and Symphony Robotics Announce Strategic Collaboration to Launch AI-Driven Micro-Robotic Platform for Laser Ablation in the Brain
Alliance aims to deliver breakthrough precision with laser ablation for
complex brain tumors and expand minimally invasive care
Asahi Kasei Elevates Critical Care Solutions with FDA Approval of ZOLL’s Zenix Monitor/Defibrillator
The Zenix monitor/defibrillator is designed for use in EMS and hospital settings
Clinical Trials
Zelluna Receives Positive MHRA Feedback and Strengthens UK Clinical Strategy for ZI-MA4-1 Paving the Way for First-in-Human Trials in the UK
Planned UK trial to be led by Prof. Fiona Thistlethwaite at The Christie NHS Foundation Trust, a European hub for advanced therapies, with participation from Dr. Andrew Furness at The Royal Marsden, a world-renowned centre for oncology and early-phase clinical research
Tensive publishes positive long-term clinical follow-up data in Breast Cancer on REGENERA™ / SOFTAG™ breast implant
The data show that positive outcomes were maintained after 24 months of follow-up following placement of the device in breast-conserving lumpectomy surgery
No Difference in Transplant Outcomes Seen for Patients Unlikely to Find a Matched Unrelated Donor When a Donor Search Prognosis Strategy is Used
Published in the Journal of Clinical Oncology, results showed no difference in any outcomes, including overall survival, at two years post-evaluability
Biotechnology News
Summit Cancer Center Director, Arvind Chaudhry, MD, PhD, to Chair Coeur d’Alene Hematology Oncology Conference Focused on Precision-Guided Cancer Care
The conference, part of the nationally recognized Binaytara CME Conference Series, has become a cornerstone of regional medical education
Santhera Secures Agreement with Biomedica for the Distribution of AGAMREE® (Vamorolone) in Russia
Dario Eklund, Chief Executive Officer of Santhera, said: “This agreement will enable more children to access this important DMD treatment, and is the latest in a series of global agreements secured in 2025. We look forward to working closely with Biomedica in the months ahead.”
Veracyte Announces that Decipher-Enabled Biomarker Predicts Hormone Therapy Benefit in Men with Recurrent Prostate Cancer
Findings from the first prospective validation trial for biomarker presented at ASTRO 2025
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
Skin May Become the First Organ to Fulfill the Promise of Regenerative Medicine | By Dr. Ned Swanson – President & Chief Medical Officer of PolarityBio
The field of regenerative medicine may be on the cusp of an evolution, and due to the unique attributes of skin and wounds, the largest organ in the body may be emerging as a leader
Pinpointing the Invisible Source of Chronic Low Back Pain | By Brent Ness, CEO of Aclarion
Intense chronic low back pain (CLBP) is a global epidemic that plagues over 266 million people worldwide – we are not referring to the kind of sore back that you have after a long flight or weekend sleeping on your friend’s sofa, but rather the grinding, “drops you to your knees” pain that prevents you from going to work or school
Bioactive Precontoured Wedges: Redefining Deformity Correction in Foot & Ankle Surgery | By Scott Day, Vice President of Global Marketing & Business Development, NovaBone
A Catalyst for Change in Osteotomy Care
FDA Medical Device Updates
Thirona Receives FDA Clearance for LungQ® 4 Software, Expanding AI-Powered Capabilities in Lung Image Analysis for the U.S. Market
This new clearance builds on version 3 of LungQ®, cleared by the FDA last year, which introduced advanced lung segmentation capabilities – a critical foundation for accurate analysis on a regional level
Zeta Surgical® AI-powered TMS Navigation System Receives FDA 510(k) Clearance
“This clearance classifies the system under product codes QFF and SGE—and, to our knowledge, marks the first TMS navigation device cleared under SGE,” said Hieu Le Mau, Chief Operating Officer at Zeta Surgical. “It provides a clear regulatory pathway for broader adoption.”
NEXTBIOMEDICAL Announces First Patient Enrolled in U.S. FDA Pivotal Trial of Nexsphere-F™ for Knee Osteoarthritis Pain
The study is designed to compare genicular artery embolization (GAE) with Nexsphere-F™ to intra-articular corticosteroid injections, with the primary goal of assessing both safety and efficacy in patients with painful knee osteoarthritis. Nexsphere-F™ has already received multiple key U.S. regulatory designations, including FDA Breakthrough Device Designation, CMS IDE Category B approval, and participation in the TAP (Total Product Lifecycle Advisory Program).
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Kihealth Raises $5M in Oversubscribed Seed Round to Launch First-of-Its-Kind Diabetes Diagnostic
The funding supports the commercial rollout of Kihealth’s first laboratory-developed, minimally-invasive test that measures biomarkers of beta cell apoptosis, the earliest marker of insulin resistance and chronic diseases such as diabetes
INTEGRA Biosciences Group acquires shares in CleanNA to strengthen their strategic partnership and drive global growth in molecular biology
CleanNA specializes in developing and manufacturing high quality magnetic bead-based DNA/RNA extraction and purification kits, making it an ideal fit to complement INTEGRA Biosciences’ offerings.
OpenEvidence Acquires Google Ventures-Backed AI Startup, Amaro
Amaro was built to help companies analyze and optimize end-to-end advertising deployment using fast, intelligent automation
CAMP4 Announces an Oversubscribed Private Placement of up to $100 Million to Advance First-in-Class Treatment for SYNGAP1-Related Disorders
Oversubscribed Financing led by Coastlands Capital with participation from new and existing investors and the financing to provide $50 million in upfront proceeds with the potential for up to an additional $50 million of proceeds to fund the Phase 1/2 clinical trial in patients with SYNGAP1-related disorders, expected to initiate as early as 2H 2026
Market Reports
Advancements in Imaging
Philips and Masimo announce innovation partnership to advance access to patient monitoring measurement technologies
This expanded agreement reflects our commitment to empower clinicians with smarter, more integrated technologies that support better outcomes across the continuum of care
GE HealthCare announces intent to acquire icometrix to strengthen neurology portfolio with brain MRI assessment solutions
The anticipated acquisition aligns with GE HealthCare’s precision care strategy with the goal of strengthening the company’s portfolio of offerings in neurological care and its quantitative analysis of brain MRI
Olympus Announces U.S. Launch of Newest Imaging Platform for ENT and Urological Applications
The company reports the U.S. launch the VISERA™ S OTV-S500 imaging platform, which integrates advanced diagnostic capabilities for ear nose and throat (ENT) and urology applications and offers flexibility for office and outpatient settings
Hospitals In the News
MemorialCare Launches Da Vinci 5 Robotic Surgical System, Expanding Robotic Surgical Program Access Across All Hospitals in Health System
ext-generation technology enhances precision, improves patient outcomes, and expands minimally invasive surgery across Long Beach, Fountain Valley and Laguna Hills
Minimally Invasive Procedure Relieves Painful Symptoms of Knee Osteoarthritis
Results of the study were published online Aug. 12 in the Journal of Vascular Interventional Radiology.
Palm Beach Gardens Medical Center Becomes First in Southeast U.S. to Use SOUNDSTAR CRYSTAL™ Ultrasound Catheter
“This milestone is another example of how Palm Beach Gardens Medical Center invests in cardiovascular innovation,” said Erik Cazares, CEO of Palm Beach Gardens Medical Center
Medical Device and Biotechnology Executives: Innovative Professionals on the Move and Making Waves in the Industry
Non-Profit News
Deep Learning Model Estimates Cancer Risk of Lung Nodules
Lung cancer remains a significant global health issue, causing the most cancer-related deaths worldwide. Screening high-risk individuals with low-dose chest CT has been shown to reduce lung cancer mortality. However, early screening trials have reported high false-positive rates, leading to unnecessary follow-up procedures, increased patient anxiety and health care costs.
AAOS Updates Clinical Practice Guideline for the Management of Rotator Cuff Injuries
The updated CPG includes 21 recommendations (14 strong and seven moderate) and eight options (four limited and four consensus). Options are formulated with low-quality evidence, no evidence, or conflicting evidence
Healthcare - Understanding the Business Side of the Industry and Its Implications
3 Most Effective And Trusted Methods For Active Protein Purification
Purifying proteins is a crucial step in ensuring the reliability and accuracy of experiments
The role of eTMF Software in ensuring audit readiness
Audit readiness is one of the most critical requirements in clinical research. Sponsors, CROs, and research sites must be prepared at any time for inspections
How Generational Changes Are Shaping Healthcare Careers
The variety of perspectives across age groups shows how dynamic healthcare careers have become
The Evolving Role of Advanced Practice Providers in Modern Healthcare
Advanced Practice Providers, a group that includes nurse practitioners, physician assistants, and clinical nurse specialists, have stepped into this space, becoming a vital part of patient care across the United States
Healthcare Careers
Nurses Corner
Nominations Open for Fifth Edition of Aster Guardians Global Nursing Award 2026 Worth USD 250,000
Registered nurses worldwide can apply in their preferred language by 10th November, 2025
Flax Health Raises $3.5M Pre-Seed to Bring AI-Powered Automation to Tackle Administrative Burden in Skilled Nursing Facilities
Flax Health, the AI-powered platform for skilled nursing facilities, today announced it has raised $3.5 million in Pre-Seed funding. The round was co-led by Sorenson
Nursa Launches Artificial Intelligence for Nurse Scheduling
The first-of-its-kind smart scheduling tool helps organizations post single or bulk shifts within seconds so they can reach qualified, available clinicians immediately
