- HeartBeam Teams Up With HeartNexus to Deliver Cardiologist-Level ECG Insights Anytime, Anywhere
- CMS Issues National Coverage Determination for Recor Medical’s Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension
- Pressure vs. Vacuum Thermoforming: Which Solution Delivers Greater Profit Margins
- Skin May Become the First Organ to Fulfill the Promise of Regenerative Medicine | By Dr. Ned Swanson – President & Chief Medical Officer of PolarityBio
- Terumo Interventional Systems Announces Its New OPUSWAVE® Dual Sensor Imaging System and DualView® Imaging Catheter Receive FDA 510(k) Clearance
- Types of Equipment That Surgeons Need for Their Practice
- MGI Tech partners with Eva Holding Group to enhance the accuracy of disease monitoring
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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
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
Relief Cardiovascular Announces First-in-Human Procedures with World’s First Transcatheter Smart Implant for the Treatment of Congestion in Heart Failure
The breakthrough procedures were performed in the Republic of Georgia as part of a feasibility study evaluating the system’s safety
HeartBeam Advances Power of ECG with High-Fidelity At-Home Heart-Monitoring System
The system’s design emphasizes user friendliness and portability while aligning with the growing trend toward remote patient monitoring and telemedicine. HeartBeam to initiate commercial launch upon FDA clearance of 12-lead ECG synthesis software, anticipated later this year
Rapid Nexus Unveils First-Ever Medical Technology to Regrow Nerves and Stop Amputations in Diabetic Patients
This patented breakthrough is the first and only technology to treat dying tissue and regenerate nerves — restoring circulation, reversing chronic wounds, and preventing amputations for patients who previously had no options
Clinical Trials
PRD Therapeutics Announces Initiation of First-in-Human Study for PRD001
This FIH Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and the signs of early efficacy (LDL-C lowing effect, and liver fat quantitative value using MRI-PDFF) of PRD001 in adult healthy volunteers.
Valar Labs’ CHAI Biomarkers Enhance Bladder Cancer Prediction | New Study in European Urology for Predicting Outcomes of High Grade Ta Bladder Cancer
The study finds that CHAI (Computational Histology AI) biomarkers stratify recurrence and progression outcomes independently and outperform current guideline-based risk stratification
Clear Guide Medical LUMENA ™ Featured in SPIE Study on MRI-Guided Interventions
The study, titled “Augmented reality system for MRI-guided interventions: a cadaver study”, demonstrates the system’s potential to enhance MRI-guided needle procedures by improving procedural feasibility and reducing the need for repeated imaging scans.
Biotechnology News
Top 6 Trends Shaping the Future of CDMO Services
The global CDMO services market has expanded rapidly, projected to reach roughly $258 billion by 2028, reflecting this outsized demand.
Precisio Biotix Therapeutics, Inc. Announces Dosing of a 1st Patient with ClyO (Staph Lysin) to Treat a Multi Drug-Resistant Prosthetic Joint Infection
The FDA approved this treatment under a compassionate.
Orphalan Partners with MAP International and the Wilson Disease Association to Provide Life-Changing Medicine to Underserved Communities
Through this partnership, Orphalan will donate a supply of Cuvrior® to MAP International, a global humanitarian health organization with over 70 years of experience distributing critical medicines to communities in need.
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
GC Biopharma Receives FDA Approval for its U.S. Plasma Collection Center in Calexico, California
With this approval, ABO Holdings is now operating all six plasma collection centers—two each in California, Utah, and New Jersey.
Carr Tech Corp Celebrates FDA 510(k) Class II Approval of FROG All-in-One Filter Needle
This transformative device advances safety and efficiency in drug preparation, underscoring the startup’s journey from solo founder to FDA-cleared innovator.
CereVasc’s eShunt® System Gains FDA Breakthrough Designation
“The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” said Dan Levangie, Chairman & CEO of CereVasc, Inc. “We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease.”
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Bioness Medical Announces Acquisition of the Assets and Business of Harmonic Bionics
Bioness Medical further expands pipeline of next-generation robotics offerings for Neuro Rehab.
Materna Medical Announces Ellora™ and Additional Close on $20M Series B2
The round welcomed new funds GLIN Impact Capital, Wealthing VC Club, and Citrine Angels, and was led by InnovaHealth Partners and other key existing investors.
Glytec Secures $36 Million Growth Investment to Accelerate AI-Powered Diabetes Technology Platform Innovation
This significant funding will fuel the continued expansion of Glytec’s platform, including its flagship Glucommander® SaaS solution, accelerate the development of innovative new technologies to address the growing global health crisis of diabetes and related co-morbidities, and support the continued rapid response to upcoming CMS quality measures that will hold health systems accountable for inpatient glycemic control.
Ceryx Medical Secures $15 Million | To Advance Groundbreaking Heart Failure Technology
Funding to drive development of permanent bioelectronic pacemaker following promising clinical data.
Market Reports
Advancements in Imaging
SubtleHD Receives CE Mark, Expanding Access to AI-Powered MRI Enhancement Across Europe Reports Subtle Medical
SubtleHD sets a new benchmark in image quality and speed for European MRI providers.
NeuralCure AI Announces Partnership with Life Imaging FLA
This partnership immediately positions NeuralCure AI for rapid, real-world application, further solidifying its role as a pioneer in AI-powered healthcare solutions. Unlike traditional AI models that provide generalized insights, NeuralCure AI creates patient-specific digital twins and runs constant treatment simulations, helping physicians make more informed, data-driven decisions without replacing clinical judgment.
Philips and Mass General Brigham: Advancing Patient Care
Discover how Philips and Mass General Brigham are transforming healthcare with innovative AI solutions for better patient outcomes.
Hospitals In the News
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 Medical Billing Software is Revolutionizing Pharmacy Operations
One area that has seen significant transformation is pharmacy operations, largely driven by the advent of medical billing software and pharmacy software systems.
Improving Hospital Culture Through Better Leadership
When leaders create an environment where people feel respected and heard, the benefits reach every corner of the hospital.
10 Tips to Expand Your Impact in Healthcare
Expanding your role doesn’t have to mean starting over or giving up your work-life balance. It can be simple, rewarding, and, yes—even fun.
Top Billing Errors in Healthcare That Can Slow Down Payments—And How to Prevent Them
The good news is that most common billing errors in healthcare are preventable with the right systems, training, and support.
Healthcare Careers
Learn How to Ace the HHA Exam
A home health aide’s job requires a certain level of training. This includes classroom hours and clinical training and passing a skills exam. HHA training
Vet and Tech: Best Veterinary Online Learning Source that Aspires Every Vet
Comprehensive online veterinary learning is the keystone to achieving success in the veterinary field. Animal health and sciences are continuously evolving due to the latest
Cosmetic Injecting Courses: What New Students Should Expect
The world of aesthetics has become one of the most popular fields in recent years for several reasons. One of the most requested procedures in
Nurses Corner
5 Ways to Balance Work, Family, and Nursing School Successfully
Nursing school is a demanding yet rewarding journey. For many students, the challenge isn’t just academic; it’s about finding that precious balance between meeting the
Breaking the Burnout Cycle: Addressing the Nursing Shortage Crisis | By: Dr. Amber Kool, DNP, RN is Associate Provost at Arizona College of Nursing
Burnout and a nursing shortage in healthcare, have reached a critical point. Even before the pandemic, the nursing profession faced challenges such as an aging workforce and increasing demand for care.
The Future of Nursing with AI: Studies from Columbia Nursing on Using AI for Nursing Education, Patient Care, Alzheimer’s Detection, and Mental Health
Columbia University School of Nursing is advancing nursing education, research, and practice to advance health for all. As one of the top nursing schools in the country, we offer direct-entry master’s degrees, advanced nursing, and doctoral programs with the goal of shaping and setting standards for nursing everywhere. And, as a top recipient of NIH research funding, we address health disparities for under-resourced populations and advance equitable health policy and delivery.