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
Portal Biotech Raises $35 Million Series A | Leveraging AI to Deliver the World’s First Full-Length Single-Molecule Protein Sequencer
June 30, 2025
Breakthrough proteomics platform technology unlocks full-length protein sequencing and characterisation, accelerating drug development and diagnostics
JLL Partners Announces Investment in Vascular Technology, Incorporated
June 30, 2025
Vascular Technology, Incorporated is a medical device company specializing in innovative surgical devices and single-use consumables for the operating room.
Industry Expert Bylines
How Prioritizing Employee Mental Wellness Creates a More Positive, Engaged Workforce | By Dawn Griffin, chief human resources & diversity officer at TRIMEDX
December 4, 2024
Organizations that prioritize employee mental wellness foster a happier, healthier workforce that is more engaged,
From Standardized to Specialized: Revolutionizing Lung Cancer Care | By Ofer Sharon, MD, CEO of OncoHost
December 2, 2024
The future of lung cancer care lies in placing each patient’s unique biology at the center of every clinical decision. Through collaboration, innovation, and an unwavering commitment to advancing science, we can move closer to a world where every lung cancer patient benefits from a truly personalized treatment plan.
Minimally Invasive Procedure Making Treatment Possible for More People with Normal Pressure Hydrocephalus | By Dan Levangie, President and CEO of CereVasc
November 22, 2024
Dan Levangie writes: CereVasc’s eShunt System is sparking interest across the field of neurosurgery. Read on to learn more.
FDA Medical Device Updates
Market Reports
Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
With this clearance, Maestro Systems can now have active Wi-Fi and 5G connectivity, enabling seamless data exchange with Maestro Insights—Moon’s cloud-based platform that gives surgical teams and administrators access to actionable insights from procedural data.
July 2, 2025
Acera Surgical Broadens Reach of Restrata ® with New FDA Clearance for Soft Tissue Reinforcement
This new clearance broadens the clinical utility of the Restrata platform, now supporting soft tissue reinforcement applications in addition to its previously cleared indications for wound healing. This clearance applies to both Restrata Sheet and Restrata Meshed products.
June 25, 2025
Executives
Former Pfizer Chief Scientific Officer Dr. Mikael Dolsten, Joins MC Sciences as Independent Chairman
In this role, Dr. Mikael Dolsten will help advance the company’s mission of developing transformative and superior therapeutics targeting and controlling mast cells across multiple high-need disease indications, and progressing to clinics and patients
August 12, 2025
Advarra Appoints Brian Hart as New Chief Technology Officer
Brian Hart will drive Advarra’s technology and product strategy, bringing continuous innovation to the development and enhancement of Advarra’s solutions.
August 4, 2025
Micro Medical Solutions Appoints George Quinoy as President & CEO to Accelerate Commercialization and Drive Value Creation
Founder Greg Sullivan will transition into the role of Chief Technology Officer to focus on advancing MMS’s technology platform, next-generation product development, and clinical evidence initiatives.
July 22, 2025
Advancements In Imaging
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.
September 19, 2024
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.
September 11, 2024
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.
September 9, 2024
Hospitals In the News
Non-Profit News
Healthcare: Understanding the Business Side of the Industry and Its Implications
Benefits of Online MRI Reporting for Busy Diagnostic Clinics
MRI scan volumes are growing fast, but are your reporting workflows keeping up? In many diagnostic clinics today, the challenge isn’t just capturing high-quality images
August 11, 2025
Insurance Eligibility Verification: A Crucial Step in Durable Medical Equipment Delivery
Insurance verification is a critical part of the process to ensure patients get their durable medical equipment they need on time.
August 1, 2025
Unlocking People Potential: The Power of Data to Drive Smarter HR Outcomes and Future Workforce Strategies
What Is Data-Driven HR? Traditionally, many HR decisions were based on intuition, legacy processes, or subjective feedback. However, the emergence of data-driven human resources turns
July 18, 2025
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.
July 13, 2025
Healthcare Careers
Nurses Corner
Health: A Comprehensive Exploration of Wellness, Nutrition, and Overall Well-Being for a Healthier Life
Articles Designed to Inspire and Guide You Toward Achieving Excellence and Success in All Your Endeavors.
August 11, 2025
