- The Medical Device Industry | Innovations Drive Growth
- IVOS Medical Joins NIH’s C3i Program to Accelerate Commercialization of BOSS G4™ Airway Management Technology
- Nexus Spine Reports: Patented Tranquil® Interbody Implants Achieve Exceptional Outcomes
- Philips and Masimo announce innovation partnership to advance access to patient monitoring measurement technologies
- How To Draw Customers to Your Trade Show Booth
- Prinses Máxima Center for Pediatric Oncology Implements Callisto™ from Volta Labs to Streamline Clinical Genomics Workflows
- OpenEvidence Acquires Google Ventures-Backed AI Startup, Amaro
Medical Device News Magazine is a digital Publication Founded in 2008, and proudly located in the United States
Medical Device News Magazine is dedicated to upholding the highest standards of journalistic integrity and accuracy, ensuring that our readers receive nothing but the most reliable information. Our commitment to excellence is exemplified in the quality and depth of the content we provide. With a team of experienced industry professionals at the helm, we strive to offer a unique perspective on the latest developments and innovations shaping the landscape of medical technology. Reading the news posted on Medical Device News Magazine, you are not only gaining access to unparalleled industry insights but also joining a community of like-minded individuals passionate about advancing healthcare through cutting-edge technologies. We invite you to explore and consider advertising!
“Medical Device News: Essential Key Insights and Noteworthy Developments Shaping the Future”
NICE Announces Fast Track Treatment Recommendation for Topical Oxygen Therapy
The updated NICE guidelines include topical oxygen therapy as an adjunct to standard care for diabetic foot ulcers that are not responding to treatment, reflecting increasing recognition from national health authorities of the clinical value and potential of TWO2® therapy to improve outcomes in difficult-to-heal wounds
Americans to Gain New Access to Real-Time Prescription Drug Price Information
Trump Administration announces forthcoming changes to ease approval of physician-approved treatments and inform patients up-front of the most appropriate and lowest cost prescription drugs

ClearFlow Selected to Exhibit PleuraFlow at Vizient Innovative Technology Exchange
Vizient, the nation’s largest provider-driven healthcare performance improvement company, will hold the Exchange Sept. 17 in Las Vegas
Clinical Research in Western Europe: How Belgium and France Are Setting New Standards
As clinical research becomes increasingly globalized, Belgium and France are expected to play an even greater role. Their complementary strengths make them attractive not just for European sponsors but for companies worldwide seeking reliable partners.

HeartBeam Advances Patient Convenience with At-Home ECG Technology
Growing clinical evidence supports the expanding role of mobile and home-based ECG capture in improving patient outcomes.
HeartBeam’s proprietary system offers a cable-free design that allows for high-fidelity ECG measurements without the complexity of conventional equipment and portable, credit card-sized design enables patients to record symptoms at home or wherever they are.
Recor Medical Announces Paradise Ultrasound Renal Denervation System Receives Manufacturing and Marketing Approval in Japan for the Treatment of Resistant Hypertension
his marks the first approval in the country for a medical device indicated for the disease
Owlet Achieves TGA Certification for Dream Sock™
Certification underscores Owlet’s commitment to bringing medically-certified infant monitoring technology to every family across the globe
Herculite Achieves 1,000 Days Without a Lost-Time Incident
This achievement highlights Herculite Associates’ commitment and vigilance in making safety a shared responsibility every single day.
Clinical Trials
Sethera Therapeutics Announces Newly Published Paper Unveils Breakthrough Enzyme That Expands Possibilities for Peptide Drug Discovery
Their findings were published late last week in Proceedings of the National Academy of Sciences (PNAS)
Spotlight Medical Announces Publication in Journal of Clinical Oncology Validating AI Pathology Assay That Identifies Low-Risk Subgroup Within Clinically High-Risk Early ER+/HER2- Breast Cancer
The assay identifies a biologically low-risk subgroup within clinically high-risk patients, with outcomes similar to stage I disease, potentially sparing 30,000 women each year from unnecessary treatment intensification

SMSbiotech Initiates Groundbreaking Phase 1 Human Clinical Trial for COPD
This milestone marks the transition of years of dedicated research into clinical development, with the goal of delivering a transformative therapy for millions living with this debilitating lung condition
Pleural Dynamics Announces Completion of Enrollment of “The ACES Study for Aseptic Pleural Effusions,” a Post Market Study Evaluating the Novel ACES Automatic Continuous Effusion Shunt System
leural Dynamics’ innovative, fully implantable, patient motion powered shunt offers patients a low maintenance option for continuous relief from pleural effusions
Biotechnology News
iXCells Biotechnologies Selected to Perform the First Pilot in Patient-Led ALS Precision Medicine Effort
The lab will run the inaugural study for Project Mosaic, a groundbreaking initiative to develop patient-specific models of sporadic ALS and fix a pipeline where 99% of treatments fail
Seek Labs Unveils Investigational, Equipment-Free Molecular Prototype for MTB on Rapid-Deploy SeekIt™ Platform
Built in a matter of months, Seek Labs’ functional investigational prototype delivers point-of-care Mycobacterium tuberculosis detection without instrumentation, electricity, or lab infrastructure
LexisNexis Recognizes Pivot Bio as One of the World’s 10 Most Innovative Biotech Startups
Karsten Temme, co-founder and Chief Innovation Officer of Pivot Bio. “Our patent portfolio reflects years of scientific innovation in developing game-changing crop nutrition solutions. Being recognized alongside the world’s most innovative biotech companies demonstrates the transformative potential of our platform.
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!

OEM Toll Processing Elevates High-Value Products | By Jeff Elliott
For specialized processes such as plasma treatments and diffusion bonding, toll processing performed by the original equipment manufacturer offers distinct advantages

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.
FDA Medical Device Updates
UroMems Receives Clearance from the FDA and the French ANSM for Initiating Landmark Pivotal Clinical Study of UroActiveÒ Smart Implant to Treat Male Stress Urinary Incontinence
IDE approval in both countries follows strong feasibility clinical results in France.
Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
With this clearance, Maestro Systems can now have active Wi-Fi and 5G connectivity, enabling seamless data exchange with Maestro Insights—Moon’s cloud-based platform that gives surgical teams and administrators access to actionable insights from procedural data.
Acera Surgical Broadens Reach of Restrata ® with New FDA Clearance for Soft Tissue Reinforcement
This new clearance broadens the clinical utility of the Restrata platform, now supporting soft tissue reinforcement applications in addition to its previously cleared indications for wound healing. This clearance applies to both Restrata Sheet and Restrata Meshed products.
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding

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.
TA Invests in HealthMark Group to Support the Next Phase of Growth
As part of the transaction, HealthMark management and existing investor Ridgemont Equity Partners will both roll meaningful ownership stakes, welcoming TA as the new lead investor. Financial terms of the transaction were not disclosed.
Aidoc Secures $150M for CARE, its Healthcare Foundation Model, to Transform Clinical Decision-Making for 100 Million Patients
Aidoc’s $150M funding will enhance clinical AI solutions, impacting 100 million patients’ care and decision-making processes.

Cooler Heads Secures Series A Funding to Revolutionize Scalp Cooling Technology for Chemotherapy Patients
By cooling the scalp before, during, and after chemotherapy, Amma™ reduces blood flow to hair follicles, shielding them from chemotherapy drugs and therefore preventing hair loss. Amma™ offers a continuous cooling system that eliminates the need for dry ice or frequent cap changes, making it a more accessible alternative to traditional methods.
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
Susan G. Komen® To Host MORE THAN PINK Walk in Milwaukee This September
Community Event to Support People with Breast Cancer, Raise Funds for Research and Advocacy Takes Place September 28, 2025 co-presented by the Ford Dealers of Wisconsin
AAOS Announces Strategic Transition of Fracture and Trauma Registry
Transition supports efficiency, participation, and long-term sustainability of orthopaedic registries
AI Tool Accurately Detects Tumor Location on Breast MRI
“AI-assisted MRI could potentially detect cancers that humans wouldn’t find otherwise,” said the study’s lead investigator Felipe Oviedo, Ph.D., a senior research analyst at Microsoft’s AI for Good Lab.
Healthcare - Understanding the Business Side of the Industry and Its Implications

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

How Staffing Platforms Improve Compliance in Healthcare
Maintaining compliance is one of the most important responsibilities healthcare facilities face—and one of the most complex

Patient Trust: The New Cornerstone of Healthcare Marketing
Trust is now the most valuable asset in healthcare digital marketing
Healthcare Careers

The Growing Demand for Compassionate Counselors in Underserved Communities
Mental health issues affect people in every corner of the country, but underserved communities continue to face the greatest challenges.

Practical Insights Into Psychiatric-Mental Health Nurse Practitioner Careers
Learn about the vital role of Psychiatric-Mental Health Nurse Practitioners (PMHNPs) in modern healthcare.

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.
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