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
Ceryx Medical Secures $15 Million | To Advance Groundbreaking Heart Failure Technology
June 11, 2025
Funding to drive development of permanent bioelectronic pacemaker following promising clinical data.
Wandercraft Announces Series D Round
June 11, 2025
Clinical progress, industrial partnerships, and global recognition drive momentum in rehabilitation, personal mobility, and humanoid robotics. The new agreement with Renault accelerates commercialization and advances Wandercraft’s global robotics footprint.
Industry Expert Bylines
Focusing Solely on US Patents Can Be a Risky Move. Here’s Why | By Christopher Cauble
September 8, 2024
Christopher Cauble’s view is that the U.S. healthcare market is big enough that good profits can be made without having to bother with the hassle of foreign patent protection, particularly patent protection in China. Read on to learn more.
The Perils of Over-Regulating AI in Healthcare and Life Sciences | By Adnan Masood, PhD. Chief AI Architect
September 4, 2024
As an AI researcher and practitioner deeply embedded in the healthcare and life sciences sectors, Dr. Masood sees the passage of California’s SB 1047 as a complex issue with significant implications. He writes this controversial bill, now heading to Governor Newsom’s desk, represents a fundamental misunderstanding of AI as a general-purpose technology. It attempts to regulate the technology itself rather than focusing on specific, problematic applications.
Advancing Fully Implanted Hearing Systems | By Brent Lucas, CEO of Envoy Medical
August 30, 2024
Envoy Medical has taken a different approach with its fully implanted hearing devices, and it looks to turn the industry on its… ear. “Listen” to what Brent Lucas, CEO of the company has to say.
FDA Medical Device Updates
Market Reports
TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System
A flowable bio-gel to protect healing tissue and preserve function.
June 9, 2025
FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System
Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has
May 30, 2025
Executives
Merck KGaA, Darmstadt, Germany, Honors Alán Aspuru-Guzik with the Heinrich Emanuel Merck Award for Computational Sciences
The Heinrich Emanuel Merck Award has been bestowed upon Alán Aspuru-Guzik, University of Toronto, in recognition of his groundbreaking innovations.
June 28, 2025
Martin Stumpe Appointed as Chief Technology and AI Officer at Danaher
Danaher Corporation (NYSE: DHR), a leading global life sciences and diagnostics innovator, today announced that Martin Stumpe will be appointed Chief Technology and AI Officer,
June 27, 2025
Greg Milosevich Appointed EVP, Life Sciences at Danaher
Greg Milosevich joined Danaher in 2010, through the acquisition of Molecular Devices, and since has held roles of increasing responsibility across multiple businesses.
June 27, 2025
Advancements In Imaging
VUZE Medical Announces U.S. FDA 510(K) Clearance for Second-Generation Software-Based 3D Guidance System for Spine Surgery
VUZE 2.0 provides much-extended interoperability and functionality; like VUZE 1.0, requires only a 2D C-arm and PC in the OR — no cameras, markers, references or tool add-ons.
May 29, 2024
Nicklaus Children’s Health System, Philips Will Provide Innovative Patient & Staff Experience, Helping to Enhance Outcomes for the Smallest of Patients
Philips AI-enabled diagnostic and experiential technologies help put patients at ease while empowering staff with faster, high-quality scans and increased diagnostic confidence.
April 30, 2024
Arineta Installs First SpotLight™ Duo Scanner
“For patients in need of cardiovascular or cardiothoracic imaging, the SpotLight Duo is the first cardiothoracic CT incorporating all of Arineta’s patient centric technologies. With one heartbeat, we can provide both high-temporal as well as iso-temporal resolution images that can be used for comprehensive cardiac and thoracic CT assessment,” said Doug Ryan, CEO of Arineta
April 11, 2024
Hospitals In the News
Non-Profit News
Healthcare: Understanding the Business Side of the Industry and Its Implications
What To Look for in Virtual Medical Scribing Software
Virtual Medical Scribing Software: The healthcare industry is constantly changing, and the introduction of medical scribing software is revolutionizing how healthcare professionals operate. With the
June 18, 2025
IoT in Healthcare: 5 Revolutionary Devices
IoT in Healthcare: The healthcare industry is rapidly adopting IoT technology. According to a report by MarketsandMarkets, the global market for IoT in healthcare will grow from $127.7 billion in 2023 to $289.2 billion by 2028.
June 17, 2025
How Individual Coverage Health Reimbursement Arrangements Are Changing Health Benefits
Many employers researching innovative ways to redesign their benefits programs are now looking into ADP’s plans and similar offerings to see how they can deliver a personalized experience without sacrificing business stability.
June 12, 2025
The EHR + RCM Combo That Mental Health Practices Have Been Waiting For
Integrating EHR and RCM systems created for mental health isn’t just a step up on technology—it is also rethinking care and administration coming together.
June 4, 2025
