- How Medical Device Companies Can Expand Their Image at Medical Meetings
- Jeff Brock Named Vice President of Account Management at HOMELINK®
- Amend Surgical Announces ISO 13485 Certification, Advancing Toward Launch of Amend Tissue Tape™
- First Patient Treated in Myra Vision’s U.S. ADAPT Clinical Study for Glaucoma
- Marketing Tips for Medical Device Companies
- Multi Unit Abutments: A Cornerstone of Predictable Implant Prosthetics
- Dr Ronald Schwartz to Purple Flag for Dementia Care Credentialing Committee
Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors.
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
MicroTransponder Announces Positive Medicare Payment Change for Vivistim® Procedure
Effective January 1, 2026, the Vivistim® procedure is assigned to New Technology Ambulatory Payment Classification 1580, with an associated national average payment of approximately $45,000
Smartee Denti-Technology Demonstrates World-Class Manufacturing Capacity to Support Global Growth
“Smartee’s advanced manufacturing ecosystem is built to scale with our global business growth,” said Mr. Haoxue Pu, Chief Technology Engineer at Smartee.
“Our cutting-edge digital production model enables us to meet the growing demand for Smartee-branded products worldwide while maintaining the highest standards of precision and quality. Furthermore, our modular production lines enable rapid responsiveness to evolving market requirements.”
Syensqo PEEK polymer enables lightweight and precise orthopedic surgical guide through Brazilian partnership
Through a collaboration between Hanisch Medical and TechImport, two leading Brazilian health technology companies, these new guides provide surgeons with a lighter and more radiotransparent alternative to traditional metal instrument
Duncan Regional Hospital Becomes First in U.S. to Implement BD Alaris™ EMR Infusion Interoperability with MEDITECH
BD Alaris™ EMR Interoperability enables seamless connection of infusion pumps into MEDITECH’s Patient Care and Patient Safety solution
Clinical Trials
Medicus Pharma Receives Full UK Regulatory and Ethical Approvals to Expand Phase 2 Clinical Study (Sknjct-003) To Non-Invasively Treat Basal Cell Carcinoma
The phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States can now expand into additional sites in United Kingdom
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
Biotechnology News
Lundbeck files for marketing authorization across key Asian markets for Vyepti® (eptinezumab) for the preventive treatment of migraine
Lundbeck is working with regulatory authorities in China, South Korea, and Japan to make eptinezumab available to patients in Asia as quickly as possible
Bioxodes presents BIOX-101 clinical data showing breakthrough potential for stroke in webcast with Prof Dr Robin Lemmens
The presentation by Prof Lemmens was a unique opportunity to learn about the clinical experience with stroke directly from an unrivalled expert. He made it very clear that intracerebral hemorrhage presents a large unmet medical need that could be addressed by BIOX-101 if further studies confirm the signals we have seen in our Phase 2a trial.
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
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
See Beyond the Surface: How Cellvizio® Redefines Accuracy for Detecting and Treating Cancers | Byline by Daryl C. Donatelli, MBA, President, U.S. & Head of Global Marketing, Mauna Kea Technologies
For patients facing a potential cancer diagnosis, the heaviest burden isn’t always the treatment; it’s the wait. The wait for clarity. The wait for answers. The wait to know whether something benign could become something more serious. And even today with wearable monitors, AI, robotic surgery, and precision medicine, some cancers still have alarmingly high prevalence and devastatingly poor survival rates[1]. Why? Read on.
Are Medical Device Companies Sleepwalking into a Skills Crisis? By Janice MacLennan, Founder and CEO, Nmblr
Janice MacLennan provides insights on the growing skills crisis in medical device companies and its impact on innovation.
Navigating change: How Advocates Can Lead Through Regulatory, Legislative Shifts | By Tim McGeath, Advocacy Counsel, TRIMEDX
Mr. McGeath shares insights on how advocates can guide industry through regulatory and legislative changes effectively.
Executives on the Move
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.”
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
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
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
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
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
Hospitals In the News
Chapter 11 Process: White-Wilson Medical Center’s Strategic Financial Move
The Company will continue operating its medical practices and patient services without interruption throughout the strategic restructuring process
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.
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
How Naturopathic Doctors Can Ensure They Have Malpractice Insurance
Malpractice insurance plays a key role in a thriving naturopathic practice. It guards your money, protects your name, and gives you and your patients peace of mind.
How Practitioners Can Stay Fully Present in Sessions
By managing mental clutter, leveraging technology wisely, creating a supportive environment, and practicing active listening, practitioners can overcome common distractions and remain deeply engaged
Understanding ACoP L8 Guidance: Your Framework for Legionella Control
Legionella remains one of the most persistent and serious risks in building water systems. Despite advances in water treatment technology, outbreaks continue to occur in settings ranging from hospitals to hotels.
Understanding the Toomey Syringe: Essential Insights and Practical Uses
Primarily engineered for precision, the Toomey syringe features a robust barrel with a distinctive tapered tip that allows for controlled delivery of fluids, whether they be medications, anesthetics, or other solutions.
Healthcare Careers
The Importance of Diverse Representation in Clinical Research
Suppose you’re a medical researcher or a clinical nursing practitioner studying to complete one of the many available and industry-recognized online nursing PhD programs. In
9 Ways to Land Higher Roles in Healthcare
There are several ways to ensure speedy career advancements to achieve higher roles in healthcare. The following are some strategies to achieve this goal.
The Best Workplaces for Mental Health Counselors
This article looks at the areas where mental health counselors typically find employment, what kinds of tasks they usually carry out, and how they assist their clients.
Nurses Corner
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.
How Nurses Can Help Provide Quality Patient Care in Healthcare Facilities
Nurses can provide quality care through specialized training and by developing strong relationships with patients.
The Importance of Nursing Education for the Healthcare Sector
Nursing is a vital component of the healthcare sector. Nurses play a critical role in healthcare delivery. Their part in the medical care industry has
