- Thirona Receives FDA Clearance for LungQ® 4 Software, Expanding AI-Powered Capabilities in Lung Image Analysis for the U.S. Market
- Nanopath Expands Leadership Team to Drive Next Phase of Scientific and Commercial Growth
- Philips strengthens health technology leadership with opening of new global headquarters by Her Majesty Queen Máxima of the Netherlands
- What’s the Use of Bioceramics?
- Pinpointing the Invisible Source of Chronic Low Back Pain | By Brent Ness, CEO of Aclarion
- Zeta Surgical® AI-powered TMS Navigation System Receives FDA 510(k) Clearance
- NEXTBIOMEDICAL Announces First Patient Enrolled in U.S. FDA Pivotal Trial of Nexsphere-F™ for Knee Osteoarthritis Pain
Medical Device News Magazine is a digital Publication Founded in 2008, and proudly located in the United States
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
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
Clinical Trials
Artificial Intelligence Tools Make Education Materials More Patient Friendly
“Our study shows that widely used large language models have the potential to transform patient education materials into more readable content, which is essential for patient empowerment and better health outcomes,” said Study senior author Jonah Feldman, MD, medical director of transformation and informatics at NYU Langone.
Second Phase of ADVANTAGE AF study of FARAPULSE ™ Pulsed Field Ablation System Meets Primary Safety and Efficacy Endpoints
Trial achieves positive results in the treatment of persistent atrial fibrillation.
CorWave Completes 6-Month In Vivo Study for Clinical Trials Initiation
In vivo studies demonstrated the pump’s successful operation for a period of up to six months. Additionally, nine chronic ovine implants were conducted for 60 days with no device failure or sign of thrombosis at explant. These significant milestones mark the final stage of CorWave’s preclinical development, paving the way for its First-In-Human study.
Biotechnology News
Neogap Therapeutics Selected for EIC Soft-landing Programme in Boston
The EIC Soft-landing Programme provides business development support and opportunities to connect with investors, academic institutions and life science stakeholders in Boston – a global hub for cancer research and biotechnology. Neogap’s combination of AI, bioinformatics and cell biology in developing personalised immunotherapy aligns well with the programme’s focus on deep tech companies.
BD Launches Landmark Cell Analyzer Featuring Breakthrough Spectral and Real-Time Cell Imaging Technologies
BD SpectralFX™ Technology maximizes the number of colors that can be used in flow cytometry, allowing scientists to analyze up to 50 or more characteristics of a single cell at one time, with optimal resolution and sensitivity, which is ideal for scientists pursuing novel biomarker discovery.
Piramal Pharma Ltd. Continues to Invest In USA; $90M in Expansions of Two US Sites
Addition of commercial-scale sterile injectables capabilities in Lexington, KY.
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
Co-Diagnostics Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance
The decision by Co-Diagnostics to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process.
Alphyn Reports: FDA Clears Breakthrough Zabalafin Hydrogel for Atopic Dermatitis Treatment
“Zabalafin Hydrogel is on the cutting edge of an evolution in AD therapeutics to treat directly for the first time all aspects of the disease simultaneously. We believe it will be the compelling therapeutic choice to treat AD, offering excellent patient tolerability for worry free, long-term and continuous use, and comprehensive treatment for itch, inflammation, and managing the bacterial microbiome imbalance on the skin that exacerbates the disease and its flare-ups.”
Aidoc Secures Landmark FDA Clearance for 1st Foundation Model-Powered Clinical AI Solution of Its Kind
“This isn’t just an upgrade, it’s a paradigm shift,” said Reut Yalon, PhD, Chief Product Officer, Aidoc. “Our goal is twofold: continuously enhance existing solutions with this new technology while simultaneously pushing AI into new frontiers and expanding coverage across a broader range of conditions. This clearance is just the beginning.”
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
BDD Pharma Opens Brand New GMP Manufacturing Facility Following £2m In Funding
The BDD facility will provide cost-effective manufacturing and clinical testing for pharma and contract research organisations of all sizes.
Solace Raises $60M Series B | To Establish Healthcare Advocacy as New Standard of Care
This raise reflects accelerating market conviction that healthcare advocacy is a critical standard of care that drives better outcomes, lowers costs, and enhances patient experiences notes Solace.
SHL Medical Expands with $220M US Manufacturing Facility
SHL Medical is significantly increasing its production capacity to meet growing demand in North America while strengthening supply chain resilience.
Exciting Times Ahead for TRIMTECH Therapeutics with $31M Seed Funding
The investment will support further development of TRIMTECH Therapeutics growing pipeline of potent, CNS (central nervous system) penetrant therapeutics based on its aggregate-selective degrader molecules known as TRIMTACs. The pipeline is focused around the development of treatments for severe neurodegenerative and inflammatory disorders, including Alzheimer’s and Huntington’s disease.
Market Reports
Advancements in Imaging
AI Can Detect Lung Nodules that Could Lead to Lung Cancer Nearly 3 Years Before Symptoms & Actual Diagnosis | Study finds
The study conducted at the Phrapokklao Hospital’s Cancer Centre of Excellence in Bangkok, Thailand was led by Dr Passakorn Wanchaijiraboon, Medical Oncologist and Deputy Director using the Qure.ai chest X-ray AI solution qXR.
KA Imaging Reports: Study Demonstrates Reveal 35C’s Impact in the ICU: Enhanced Imaging, Faster Diagnosis, and Potential CT Diversion
This is a summary of a study using the Reveal 35C detector in the ICU, to be presented at this year’s American Society of Emergency Radiology Meeting reports KA Imaging.
MAUI Imaging Emerges From Stealth With $4 Million Department of Defense Contract To Support Trauma Medicine
MAUI Imaging CEO and co-founder David Specht. “The feedback we have received from physicians and technologists highlights the profound need for a new ultrasound-based technology that enables imaging of all types of tissues. That need is most pronounced in trauma medicine, which is a major focus of MAUI’s collaborative development efforts. Going forward, MAUI will be able to supply the volumetric imaging data for AI tools that predominantly come from CT and MRI.”
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
Navigating the Digital World: What Doctors Are Doing About Bad Reviews Online
Positive and negative online reviews can be managed in various ways. In this article, we’ll explore how doctors manage their online reputation and learn how to respond to negative patient reviews.
The Benefits of Using EMR for Mental Health Practices
EMR systems enable mental health professionals to maintain and access patient records with ease, creating a more efficient workflow and better patient outcomes.
The Future of Cybersecurity: How AI and Machine Learning Are Changing the Game
As cyber threats become more sophisticated, organizations must adapt by leveraging advanced technologies to protect their data and systems. AI and ML are transforming the way cybersecurity professionals detect, respond to, and prevent cyberattacks, providing more efficient and proactive security solutions.
Protecting Surgeons’ Vision: The Critical Role of Laser Safety Glasses in Modern Operating Rooms
Surgeons face numerous risks during procedures, with eye protection being a paramount concern. Protecting surgeons’ vision is crucial, and laser safety glasses play a critical
Healthcare Careers
9 Ways To Elevate Your Healthcare Career
Healthcare is one of the most important job sectors of any society. It is a service industry that provides care and support to people experiencing
5 Things to Consider Before Searching for Temporary Physician Jobs
If you’re a physician considering a temporary job, there are several things to consider before diving in and beginning the search. Not considering these steps
Why You Should Upgrade to an Advanced Healthcare Degree?
The healthcare industry is one of the most rapidly growing and dynamic industries in the world today, with a constant need for qualified and skilled
Nurses Corner
Hospice Nurse with 3 Million Social Media Followers Partners with Medical Device Company
Hospice Nurse Julie and Hospi Corporation Team Up to Raise Awareness about the Macy Catheter
Nurse.com Unveils Next-Generation Talent Marketplace To Revolutionize Healthcare Hiring
With a deep understanding of nurses’ behavior and skills, Nurse.com utilizes next-generation technology, candidate data, and completed courses to deliver personalized job matches. This approach enables recruiters to find candidates who not only meet their organization’s needs but also fit its culture.
Archer Review Unveils Cutting-Edge Products Catering to Every Stage of the Nurse Life Cycle
“Our mission at Archer Review has always been to empower nursing students with the best tools and resources to succeed,” said Morgan Taylor, DNP, CPNP-PC, CNO of Archer Review. “With the launch of these new products, we are extending our support to cover every stage of the nurse life cycle, from aspiring students to practicing professionals.”