- The role of eTMF Software in ensuring audit readiness
- Medicus Pharma Ltd. Receives Positive Feedback From the FDA Type C Meeting Supporting the Development of Skinject
- Veracyte Announces that Decipher-Enabled Biomarker Predicts Hormone Therapy Benefit in Men with Recurrent Prostate Cancer
- FDA Grants HemoSonics 510(k) Clearance to Expand Use of Its Quantra Hemostasis System to Obstetric Procedures
- HeartBeam Advances Power of ECG with High-Fidelity At-Home Heart-Monitoring System
- Philips unveils latest CT and MR innovations in radiation therapy, advancing precision cancer care at ASTRO 2025
- How Generational Changes Are Shaping Healthcare Careers
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 News: Essential Key Insights and Noteworthy Developments Shaping the Future”
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
Octapharma Releases Results for Phase 3 Superiority Study of Pediatric Acute-onset Neuropsychiatric Syndrome
Clinical Global Impression Data Showed Statistically Significant & Clinically Relevant Improvement in Pediatric PANS Patients.
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.
Biotechnology News
Caliway Biopharmaceuticals Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat
Caliway has completed the End-of-Phase 2 (EOP2) meeting with the U.S. FDA for CBL-514, the world’s first investigational drug for large-area subcutaneous fat reduction developed under the 505(b)(1) regulatory pathway.
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.
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
5 Trends Shaping the IPO Market: Health to Fintech in 2025 | By Jack Horton
Jack Horton is a market analyst and tech industry researcher specializing in global IPO trends, emerging fintech ecosystems, and digital health innovation
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
Pinpointing the Invisible Source of Chronic Low Back Pain | By Brent Ness, CEO of Aclarion
Intense chronic low back pain (CLBP) is a global epidemic that plagues over 266 million people worldwide – we are not referring to the kind of sore back that you have after a long flight or weekend sleeping on your friend’s sofa, but rather the grinding, “drops you to your knees” pain that prevents you from going to work or school
FDA Medical Device Updates
Phantom Neuro Receives FDA Breakthrough Device & TAP Designations, Solidifying Position as a Neurotech Leader
“Receiving both of these certified designations from the FDA is a tremendous validation of our work,” said Dr. Connor Glass, Founder and CEO of Phantom Neuro. “These recognitions validate our technology and reflect our commitment to creating scalable, real-world solutions that restore functionality and independence to amputees and those with functional disabilities. Our goal is to bring Phantom X to patients faster, and achievements like this accelerate our clinical and regulatory processes.”
FDA Approves LANCELOT Technology for Corcym’s Perceval Plus, Enhancing Performance of Sutureless Aortic Valve Replacement
Lancelot Technology: CORCYM , the medical device company dedicated to providing patients and cardiac surgeons with the best solutions to fight structural heart disease, announces
FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
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.”
OrganOx Completes $142 Million Equity Financing Led by HealthQuest Capital
The oversubscribed round was led by new investor HealthQuest Capital with support from existing OrganOx investors BGF and Lauxera Capital Partners, along with additional new investors Sofina, Soleus Capital, and Avidity Partners.
Advancing Eye Health: Perceive Pharma Secures $15M Investment Boost
In addition, Perceive Pharma announced that Carol Gallagher, Pharm.D. has joined the company’s Board of Directors as an independent director.
Market Reports
Advancements in Imaging
IVUS and iFR Technologies Receive Top-level Recognition in New ESC Guidelines, Reinforcing their Role In Optimizing Coronary Interventions and Patient Outcomes
The latest updates to these ESC guidelines emphasize the robust clinical evidence supporting the use of intravascular ultrasound (IVUS) and instantaneous wave-free ratio (iFR), both of which have demonstrated significant benefits in improving patient outcomes through numerous large-scale randomized trials like DEFINE FLAIR and iFR SWEDEHEART. The updates were announced at the recent ESC Congress in London, five years after the last update in 2019, and simultaneously published in the European Heart Journal.
Bracco Imaging S.A. and Arrayus Technologies Announce Agreement to Enhance Drug Delivery for Pancreatic Cancer Treatment Using Focused Ultrasound and Microbubble Technology
Under the terms of the agreement, Bracco Imaging will supply Arrayus with microbubbles for use in the development and commercialization of its focused ultrasound platform for pancreatic cancer.
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.
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
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
Telemedicine: Bridging the Gap in Healthcare Access and Delivery
The healthcare industry has seen significant changes and transformations in the rapidly advancing world of technology. One of the most groundbreaking developments in recent times
Top 10 Must-Have EMS Vehicle Equipment for Emergency Responders
Modern EMS vehicles require comprehensive medical equipment and supplies, with costs averaging around $19,000 per vehicle to ensure readiness for any emergency scenario.
How to Ensure Your Business Meets FDA Compliance Standards
Business Meets FDA Compliance Standards:
Healthcare Careers
Nurses Corner
How Often Should Nurses Update Their Skills?
Continuing professional development (CPD) has many advantages for nurses. Namely, being able to broaden their professional horizons while refreshing their existing skills, and also, staying abreast of industry advancements.
Laudio Expands Work With Children’s National Hospital to Include Nurse Educators
“Setting nurses up for success, supporting them effectively, and ultimately retaining them requires increasingly proactive, comprehensive strategies,” said Tom Hills, EVP of Client Engagement at Laudio. “We are excited to welcome nurse educators at Children’s National into the Laudio community.”
American Academy of Nursing Announces the 2024 Class of New Fellows
The newest Fellows represent 37 states, the District of Columbia, Guam, and 14 countries. Their expansive body of knowledge will soon bolster the collective impact of over 3,000 Academy Fellows who together, leverage their expertise to advance the Academy’s vision of healthy lives for all people.
