- MGI Tech partners with Eva Holding Group to enhance the accuracy of disease monitoring
- FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy’s Disease
- Sanofi Deepens Partnership with Medidata | To Expedite the Development of New Therapies with an Improved Patient Journey
- HOMELINK® Appoints Allan Schroeder as Vice President of Managed Care
- Invenra Inc. and Xcellon Biologics Announce Collaboration to Advance Bispecific and Trispecific Antibody-Drug Conjugate (ADC) Development
- Materna Medical Presents a Sub-Analysis Comparing Outcomes on a Spectrum of Menopausal Women, Showing Significant Improvements at Three Months
- MinXray to Showcase Collaboration, Art and Technology at the Union World Conference on Lung Health 2025
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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
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
BD to Initiate Real-World Patient Data Registry for the Rotarex™ Atherectomy System in Treatment of Peripheral Artery Disease
Known as “XTRACT,” this prospective, multi-center, single-arm, post-market registry study will assess the clinical performance of the Rotarex™ Atherectomy System in the treatment of U.S. patients with PAD lesions.
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.
Biotechnology News
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.
Nuclera Establishes a Distribution Network Across APAC and the Middle East
Operational expansion accelerates global distribution capability to increase regional access and technical support. Multiple partnerships establish direct distribution channels in China, Japan, South Korea, Singapore and Israel.
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
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
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.
Boston Scientific Reveals Agreement to Acquire SoniVie Ltd.
“Renal denervation for hypertension is an exciting medical advancement for the millions of patients it may help and is supported by positive results from contemporary clinical trials and ongoing research,” said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. “We believe the addition of the differentiated, ultrasound-based TIVUS system can complement our expansive interventional portfolio with a minimally invasive therapy for patients with hypertension and provides opportunity for future advancements in this space.”
Market Reports
Advancements in Imaging
Life Molecular Imaging and PharmaLogic announce Neuraceq® availability in Denver
“By partnering with PharmaLogic and offering Neuraceq® in Denver, Life Molecular Imaging is excited to expand access of Neuraceq® for the detection of beta-amyloid plaques in the brain. We believe this additional access benefits physicians and patients, as well as our pharma partners for routine clinical and research use. We are excited to collaborate with Pharmalogic today and look forward to more opportunities in the future. ” said Ludger Dinkelborg, Ph.D., Managing Director at LMI.
Carilion Clinic Further Expands Quality Cardiac Care Access with Latest Philips Innovations at New Regional Cardiovascular Institute in Virginia, US
“At Carilion Clinic, we are committed to improving the health of the communities we serve. We know that collaboration is an essential component to realizing this vision,” said Marguerite Underwood, Vice President for the Carilion Clinic Cardiovascular Institute. “Working with Philips ensures that we will be able to set the standard in cardiovascular care, not only today, but well into the future.”
Bon Secours Mercy Health and Philips Sign Multi-Year Strategic Collaboration
“This collaboration is part of our commitment to drive improved healthcare quality while reducing costs and addressing healthcare issues facing entire communities,” said Jodi Pahl, Chief Nursing Officer for workforce experience and nursing outcomes, Bon Secours Mercy Health. “This 10-year journey will bring innovations that will transform care delivery.”
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
Looking for a Career in the Medical Sector?
The medical field is something you cannot take lightly nor is it for the faint of heart. It requires a person’s full attention, dedication, and
How Can You Improve Your Medical Career?
Are you looking for ways to advance your medical career? Growing as a professional in the medical field can be difficult and complex. It involves
What Are the Duties of a Pharmacy Technician?
The Healthcare industry is constantly growing. As the industry grows, changes and evolves, the demand for professionals in the field grows concurrently with it. Pharmacy
Nurses Corner
University of Phoenix College of Nursing Dean Dr Raelene Brooks Featured Speaker at Healthcare in the Age of Personalization Summit
“Patients deserve personalized, empowered care by their healthcare providers,” states Dean Dr Raelene Brooks. “Healthcare providers are experts in their field and when committed to the very best patient care and experience, they can be powerful and collaborative advocates working alongside patients and other providers. I look forward to sharing insights from our own experience training and empowering our nursing students to also be patient advocates.”
Covalon Technologies Presents Compassionate Care Technology at the Infusion Nurses Society (INS) Annual Meeting & Exhibition in Kansas City, MO
Not all vascular access dressings are made the same, and Covalon Technologies is excited to showcase more compassionate solutions at the Infusion Nurses Society Annual Meeting and Exhibition.
AIS Healthcare Celebrates National Nurses Month
AIS Healthcare nurses hold certifications in specialty infusion care and undergo advanced and ongoing clinical training, allowing them to provide patients with the best possible care.