- 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
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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”
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
New AlarmSense by Nihon Kohden Aims to Alleviate Alarm Fatigue
AlarmSense™ is an advanced, data-driven analytics solution designed to intelligently streamline hospital response management and combat widespread alarm fatigue
presentation given by Daniel Spratt, MD, of the University Hospitals Seidman Cancer Center at Case Western University, and the principal investigator of the BALANCE trial
Researchers present findings from top-rated studies at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting. For more information about radiation therapy for cancer
How to Use the HeartBeam System | Video for the Practicing Specialist
The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional
Clinical Trials
Carolina Molecular Inc. and Astoriom to Collaborate on Integrated Molecular Testing and Biospecimen Storage Services
Research Triangle Park-based companies provide comprehensive testing and sample storage to CROs, CDMOs, Pharma and Biotech Partners
Medtronic initiates global pivotal study of cardiac pacing in a new patient population
Study to evaluate whether a new approach to pacing the heart can improve the lives of patients with heart failure with preserved ejection fraction (HFpEF) who have limited treatment options today
Nexus Spine Reports: Patented Tranquil® Interbody Implants Achieve Exceptional Outcomes
Each patient received a Nexus Spine Tranquil® cervical interbody cage at one or more spinal levels, and, as a control, some patients received one or more competing interbody devices at adjacent level(s)
Biotechnology News
SynGenSys introduces NK.SET synthetic promoter library to advance natural killer cell therapies
Developed using the Company’s proprietary informatics and design workflow, NK.SET is a synthetic promoter library designed to enable precise, tuneable gene expression in natural killer (NK) cell immunotherapies, to improve both efficacy and targeting
Best Biomarker Testing Companies in 2025
Biomarkers are now the currency of precision medicine and preventive health. Choose the partner that matches your goals, whether that is advancing a clinical trial, validating a new drug, or extending healthspan
FUJIFILM Biosciences Introduces BalanCD HEK293 Perfusion A Medium to Enable Gene Therapy Production
First commercially available cell culture solution for HEK293 cells and perfusion -– optimized for high cell density (HCD), intensified processes and perfusion cultures. Additional capabilities for continuous Adeno-Associated Virus (AAV) and Lentivirus (LV) production for consistent quality, performance, and scalability.
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
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).
Medicus Pharma Ltd. Receives Positive Feedback From the FDA Type C Meeting Supporting the Development of Skinject
The FDA agrees that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat basal cell carcinoma (BCC) of the skin using dissolvable Doxorubicin-containing Microneedle arrays (D-MNA) representing ~$2 billion in potential market opportunity
FDA Grants HemoSonics 510(k) Clearance to Expand Use of Its Quantra Hemostasis System to Obstetric Procedures
he Quantra Hemostasis System provides comprehensive blood analysis that delivers rapid, real-time coagulation insights at the point of need, empowering clinicians with actionable data to make better decisions and protect mothers who experience postpartum hemorrhage during childbirth. Quantra is the first and only cartridge-based FDA-cleared viscoelastic testing platform for obstetrics
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
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
Method AI Raises $20M in Series A Financing
To enhance physician visualization during surgical oncology procedures. New funding to support building image-guided surgical navigation platform.
Clinisupplies Acquires Renew Insert Portfolio to Continue Building a Leading Chronic Care Organisation
The acquisition of the Renew Inserts range will enable Clinisupplies to expand its bowel management offering, while also supporting patients living with chronic bowel issues through its nursing and homecare services.
Aptitude Awarded a BARDA Contract Modification to Add Avian Flu Detection to the Metrix® Platform
This funding will support the development of Avian H5 Influenza detection capabilities on the Metrix® platform, expanding upon its recent U.S. Food and Drug Administration (FDA) emergency use authorized COVID-19/Flu multiplex test.
Market Reports
Advancements in Imaging
Philips Launches Transcend Plus for EPIQ CVx and Affiniti CVx, Delivering Breakthrough Image Quality and FDA-cleared AI Enhancements In Cardiovascular Ultrasound
Next-generation 2D and 3D imaging and intelligent automation empower clinicians to make faster, more confident decisions in cardiac care
Akumin Reports: First 2 Innovative Akumin AXIS™ Expandable Patient Units Deployed at Hospital Partner Locations
Each unit features state-of-the-art PET/CT imaging technology and is purpose-built to enhance patient and staff experiences, improve workflows, and expand access to care in these communities
Body Vision Medical Expands Access to AI Tomo® with Major LungVision® Platform Upgrade
This achievement enables AI Tomo to be used with nearly any fluoroscopic C-arm model, marking another significant milestone in the company’s mission to improve early and accurate lung cancer diagnosis worldwide.
Hospitals In the News
New Data Show Better Outcomes for Hospitalized Surgical Patients
Patients in the hospital for surgeries had better outcomes in 2024 than they did in 2019, according to a new report released today by the American Hospital Association and Vizient®
Good Samaritan Medical Center Acquires State-of-the-Art da Vinci 5® Surgical System
The addition of this cutting-edge technology reinforces the hospital’s commitment to offering patients the highest level of surgical precision and minimally invasive care.
AI-Assisted Technique Can Measure and Track Aging Cells
Led by NYU Langone Health Department of Orthopedic Surgery researchers, the study included training a computer system to help analyze animal cells damaged by increasing concentrations of chemicals over time to replicate human aging.
Medical Device and Biotechnology Executives: Innovative Professionals on the Move and Making Waves in the Industry
Non-Profit News
Healthcare - Understanding the Business Side of the Industry and Its Implications
Physician Onboarding & Integration Programs | Healthcare Professional Development
Through systematic attention to pre-arrival planning, structured orientation, clinical integration, cultural assimilation, and long-term support, healthcare organizations can create onboarding programs that attract excellent physicians, facilitate their success, and contribute to sustainable organizational excellence that serves patients and communities effectively
Why is AI Healthcare Scribe Essential for Clinicians in 2025
AI medical scribes play a crucial role for clinicians and patients. Traditional scribes create documentation and burnout crises, security and privacy issues, and poor communication between physicians and patients, while AI ambient scribes can effectively address documentation crises, reduce burnout, enhance patient experience and well-being, and offer cost-effective and scalable solutions
How to Effectively Use Digital Billboards
Advertising has come a long way since paper-painted signs were posted on the side of the road. Now, digital billboards convey your brand narrative more effectively than
Bleach-Infiniter in Chicago: Helping Clinics Compete Without Extra Costs
Learn how Bleach-Infiniter helps Chicago clinics enhance services without added expenses, boosting competitiveness in healthcare
Healthcare Careers
Nurses Corner
DUES is Changing the Future of Scrubs
Blending purpose, performance, and elevated design, DUES sets a new standard for apparel that is versatile, stylish, and functional.
American Academy of Nursing Designates Renowned Philanthropists as Honorary Fellows
The Conways and Ms. Johnson are being honored for their extraordinary and sustained contributions to health care and the nursing profession throughout their careers, which have been marked by their notable charitable efforts over many decades.
Leeza Constantoulakis Named Chief Nursing Officer at Drive Health
Mission-driven healthcare leader brings over a decade of clinical nursing, policy, and technology expertise to leading Agentic AI healthcare startup.
