- restor3d Announces 1st Clinical Cases of the iTotal Identity™ CR 3DP Porous Fully Personalized Total Knee Replacement System
- AngelEye Health Secures Additional $9 Million to Accelerate Innovation in Neonatal and Pediatric Care
- Earned Acquires OJM Group
- Montagu and Kohlberg to Acquire Teleflex Medical OEM in a Carve-out Transaction
- VALANX Biotech establishes Board of Directors
- Saluda Medical Raises $150M USD to Fuel Growth Following ASX IPO
- Byron Jobe Recognized as One of Modern Healthcare’s 100 Most Influential People in Healthcare
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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 Industry News: Latest Developments, Breakthroughs, and Future Outlook
HAPPE Spine Reaches 1,000 Patients with the INTEGRATE®-C Interbody Fusion System
HAPPE Spine also announces completion of the MedTech Innovator 2025 Accelerator Cohort
Sectra Reports: Large health system in southeast US adopts Sectra’s cloud service across 11 sites to ensure reliability in their delivery of excellent patient care
As Sectra One Cloud is a fully managed cloud solution, Sectra will monitor, optimize, and continuously upgrade the solution, alleviating the burden from the healthcare system’s IT teams
ViTAA Medical Secures FDA 510(k) Clearance for AiORTA™ Plan — Marking the First Step in Its Hyper-Precise Aortic Care Platform
ViTAA Medical reports FDA clearance marks a pivotal milestone in ViTAA’s broader AiORTA™ suite, designed to support physicians across the full continuum of aortic care.
Coreline Soft Chosen as Exclusive AI Provider for France’s IMPULSION Lung Cancer Screening Pilot
APHP-led IMPULSION project secures Coreline Soft as sole AI supplier
Clinical Trials
FastWave Medical Completes Coronary Laser IVL Study Enrollment, Secures 9th U.S. Patent
Successful study enrollment and patent issuance highlight FastWave’s continued momentum with its Sola™ coronary laser intravascular lithotripsy platform notes Fastwave Medical.
Materna Medical Presents a Sub-Analysis Comparing Outcomes on a Spectrum of Menopausal Women, Showing Significant Improvements at Three Months
Data presented at the Menopause Society Annual Meeting compared Milli expanding vaginal dilator therapy results in women over and under age 50
Journal of Clinical Microbiology Publishes Article on ARUP’s Validation of AI for Parasite Detection
“Our validation studies have demonstrated the AI algorithm has better clinical sensitivity, improving the likelihood that a pathogenic parasite may be detected,” said Blaine Mathison, BS, M(ASCP), technical director of Parasitology at ARUP and lead author of the article
Biotechnology News
Switzerland Emerges as a Safe Haven for Life Sciences
Often considered a world leading life sciences supercluster, the Basel region is already the global headquarters for some of the world’s top pharmaceutical and biotech companies
Pluri Partners with Miss Universe Skincare Introducing Exosome-Enhanced Regenerative Skincare
Pluri notes the launch follows Cellav’s first secured commercial collaboration with Miss Universe Skincare (“Miss Universe Skincare”), a global skincare and beauty brand. The collaboration will focus on the co-development of a new line of advanced, cell-based skincare products
MGI Tech partners with Eva Holding Group to enhance the accuracy of disease monitoring
The initiative aims to expand Brazilian patients’ access to genomics, including joint efforts in the development of the country’s genetic sector
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
Digital Pathology Reaches an Inflection Point as AI Targets Workflow Gaps | By Yair Rivenson, PhD Founder and CEO, Pictor Labs
Laboratories face mounting pressure to modernize imaging, preserve tissue, and reduce sequencing failures as adoption continues to move at a glacial pace
FIZE Medical Launches 5,000-Patient Retrospective Study to Further Establish the benefits of using FIZE kUO in managing ICU patients’ Hemodynamic status
By continuously capturing renal function patterns, the study aims to demonstrate how FIZE kUO® can provide data for early signs of instability that are often missed by intermittent measurements
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
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
Amae Health Announces $25 Million Series B to Advance Toward a Cure for Severe Mental Illness
Amae Health notes the Series B round, led by Altos Ventures with participation from existing investors, will accelerate Amae’s AI-powered precision-care platform and partnerships with leading academic medical centers—marking a decisive step toward curative psychiatry
Sanofi Deepens Partnership with Medidata | To Expedite the Development of New Therapies with an Improved Patient Journey
Expanded 10-plus-year collaboration will leverage Medidata Experiences, enabling Sanofi to streamline operations, refine data quality, and enhance patient care
Catalyst OrthoScience announces $15M in financing
RC Capital, Mutual Capital Partners and Western Alliance Bank reinforce long-term confidence in Catalyst’s vision and leadership; Dr. Theodore Blaine joins Catalyst board of directors
Boston Scientific Announces Agreement to Acquire Nalu Medical
The Nalu Neurostimulation System is designed to deliver targeted relief for adults living with severe, intractable chronic pain of peripheral nerve origin, including areas such as the shoulder, lower back and knee, through peripheral nerve stimulation
Market Reports
Advancements in Imaging
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
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
Hospitals In the News
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
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.
Medical Device and Biotechnology Executives: Innovative Professionals on the Move and Making Waves in the Industry
Non-Profit News
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
The Growing Importance of Vendor Partnerships in Healthcare Environments
Vendor Partnerships in Healthcare Environments Healthcare environments today look much different from those of even a decade ago. You now see hospitals and clinics navigating
Forget Textbooks – The 5 Ways E-Learning for Healthcare is Creating Smarter Doctors
E-learning in healthcare is revolutionising medical education by providing flexible, evidence-based learning experiences. It helps doctors improve clinical knowledge and deliver higher standards of patient care. Read this article for more details!
Pressure vs. Vacuum Thermoforming: Which Solution Delivers Greater Profit Margins
The right selection of a thermoforming system for your clinic or lab depends on your objectives. If you are looking to maximise efficiency, quality, and profitability in the production of thermoformed appliances, you should definitely opt for pressure thermoforming.
Types of Equipment That Surgeons Need for Their Practice
Surgeons need a wide range of tools to do their job well, including devices for diagnosis, instruments for surgery robotic systems, and ways to manage tissue
Healthcare Careers
What Soft Skills Are Needed for A Career In Healthcare?
Soft skills are more than medical expertise and they are important in cultivating a holistic approach to patient care that creates trust, compassion, and better collaboration between both patients and fellow colleagues. These skills are crucial for oncoming and current healthcare professionals aiming to excel and deliver patient-centered care.
The Growing Surge in Health Science Careers and How to Navigate Your Path
Introduction As modern societies strive for better health outcomes, the role of health science professionals becomes increasingly vital. These experts are the backbone of efforts
6 Career Pathways That Lead To Becoming A Doctor
Becoming a doctor is a long and difficult process that requires many years of schooling and training. But for those passionate about helping others, it can be the most rewarding career imaginable. Many pathways can lead to becoming a doctor, but all require hard work and dedication.
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.