As regulatory bodies like the FDA continue to update drug labeling with biomarkers, the role of high-precision medical devices will only grow
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Medical Device News Magazine is committed to delivering high‑quality, in‑depth medical device news and biotechnology updates that include expert bylines. Our coverage offers a comprehensive view of the trends, innovations, and breakthroughs shaping the future of medical technology.
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Medical Device Industry News | Latest Developments, Breakthroughs & Future Outlook
Latest News
BD Delivers Next‑Generation TIPS Innovation to Advance Portal Hypertension Care Across the European Union
CE Marking and ARCH clinical trial data position the Liverty™ TIPS Stent Graft to expand treatment options for patients with advanced liver disease
Ellipsys Vascular Access System to Return to U.S. Market in 2026
Ellipsys Medical, Inc. today announced that the Ellipsys® Vascular Access System will once again be commercially available, with initial availability anticipated in mid-2026. The announcement marks the planned reintroduction of the minimally invasive technology to clinicians and patients following a period of limited market availability. The Ellipsys System, previously available...
Clinical Trials
Phantom Neuro Receives Approval for First-In-Human Clinical Study
The study's PI is Michael Lo, M.D., a leading plastic surgeon at Cabrini Health
New STORM-PE Data Show Computer Assisted Vacuum Thrombectomy with Anticoagulation Resulted in Significantly Better Functional Outcomes at 90 Days Compared to Anticoagulation Alone for Pulmonary Embolism Patients
Mechanical Thrombectomy Dramatically Outperforms Standard PE Care at 90 Days
First Implant of KingstronBio’s ProStyle M® Transcatheter Mitral Valve System Successfully Completed in National Multicenter Confirmatory Study
On March 12, 2026, the first implant of the ProStyle M® Transcatheter Mitral Valve System (ProStyle M®) was successfully completed under pure ultrasound guidance as part of its confirmatory clinical study. The device is independently developed by KingstronBio Technology (Changshu) Co., Ltd. (KingstronBio). The procedure was performed by Professor Wang Chunsheng and Professor...
Biotechnology News
Tsingke Unveils ‘Zero-Contact’ Gene Synthesis to Safeguard Core Genetic Sequences
As the pace of biotechnology research accelerates, companies are increasingly challenged to balance rapid innovation with the protection of sensitive genetic information.
Variational AI Releases Enki 4: Major Update to Foundation Model for Small-Molecule Drug Discovery
Variational AI introduces Enki™ 4: an improved algorithm and architecture designed to scale, expanding the pre-trained target coverage from 592 to 760 and now applicable to proximity-based therapeutics and novel payloads for antibody drug conjugates
Transgene and NEC Bio Sign License Agreement to Prepare the Next Steps of the Development of TG4050 in Head and Neck Cancer
Akira Kitamura, GM, AI Drug Development Division of NEC Corporation and CEO of NEC Bio, added, "This agreement is an important milestone in our partnership with Transgene and reflects NEC’s long-term commitment to the development of TG4050
Mergers & Acquisitions
Funding
Major Investment from Genome Canada to Help Advance ClarityDX Prostate Adoption Across Canada
June 26, 2025
The funding to propel widespread adoption and integration of innovative prostate cancer diagnostic test into Canadian healthcare.
Backed by $2 Million, Droplet IV is Set to Launch its Revolutionary Automatic IV-Line Flushing Device in EU & US in 2026
June 18, 2025
Droplet IV today announced the successful completion of a $2 million funding round to enable launch of its first automatic IV-line flushing device in the
Industry Expert Bylines
The Role of Endovascular Specialists in the Multidisciplinary Approach to Postpartum Hemorrhage | By Dr. Adam Power, Co-Founder and CMO, Front Line Medical Technologies
November 21, 2024
Postpartum hemorrhage (PPH) continues to challenge obstetric care despite ongoing medical advancements. With blood loss exceeding 500 ml in 6.3% to 13% of births and over 1000 ml in 1.9% to 2.8% of cases, PPH remains a significant concern. These figures are particularly worrying given that 500 ml is the established threshold for PPH following vaginal delivery. Cesarean sections often involve even more significant blood loss, frequently exceeding 1000 ml.
The Future of Precision Medicine Delivering ROI for the Healthcare Industry | By: Gary Turner, Managing Director, Additive Manufacturing, Ricoh USA, Inc.
November 19, 2024
Gary Turner asks: What do orthopedic surgery and additive manufacturing have in common? 3D surgical guides. This experts shares his views.
Transforming Diabetes Care: Why CGM Hardware Must Evolve for the Type 2 Population | By Dr. Chris Dawson, Head of Biosensing at TTP
November 6, 2024
The landscape of diabetes management is transforming, as continuous glucose monitoring (CGM) devices expand beyond Type 1 diabetes and into a rapidly growing Type 2 market. Changes to regulatory approvals and insurance coverage driven by improved patient outcomes have opened the door for non-insulin-dependent Type 2 patients to access CGM. Device manufacturers now face a new frontier: designing CGM hardware that meets the unique needs of an increasingly diverse patient population. For CGMs to realize their full potential in Type 2 diabetes management, it’s critical to rethink hardware design to cater to this population’s distinct requirements, improving usability, flexibility, and the quality of care.
FDA Medical Device Updates
Market Reports
Riliprubart Earns Orphan Drug Designation in the US for Antibody-mediated Rejection in Solid Organ Transplantation
This designation reflects Sanofi’s commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available.
June 25, 2025
Exo Launches a New Era in Disease Diagnosis with the First FDA-cleared Ultrasound AI for Detection of Pleural Effusion and Consolidation/Atelectasis
Exo Iris® now automatically detects and localizes key pulmonary findings for emergency care, showing superiority to clinicians alone.
June 18, 2025
Executives
Champions Oncology Announces Appointment of New CEO
Effective August 25, 2025.
July 18, 2025
Dr Richard J Friedman Appointed CMO at Exactech
Experienced surgeon to provide cross-functional guidance as company focuses on future growth and innovation.
July 17, 2025
Dr Julia Wright Named MolecuLight Chief Medical Officer
In this pivotal role, Dr. Wright will lead MolecuLight’s global medical and clinical strategy.
July 10, 2025
Advancements In 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.”
August 22, 2024
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.
August 20, 2024
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.”
August 20, 2024
Hospitals In the News
Non-Profit News
Healthcare: Understanding the Business Side of the Industry and Its Implications
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.
July 7, 2025
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.
July 7, 2025
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.
July 4, 2025
The Relevance of Income Protection Insurance to the Medical Industry
When considering the weighty challenges, demands, and risks associated with healthcare professions, it’s easy to conclude that income protection insurance is a prudent, responsible means to promote improved mental health and fiscal responsibility.
July 1, 2025
Healthcare Careers
February 13, 2023
Nurses Corner
Health: A Comprehensive Exploration of Wellness, Nutrition, and Overall Well-Being for a Healthier Life
December 22, 2025
