CE mark awarded for aXess™ at record speed, underpinned by strong EU pivotal trial data
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Medical Device Industry News | Latest Developments, Breakthroughs & Future Outlook
Latest News
iProcess Global Research launches AxisOne: the R&D operating system for the world
AxisOne combines artificial intelligence with milestone-based delivery to accelerate lab selection, tighten research execution, and close the accountability gap in global R&D collaboration
OrthAlign Accelerates Global Growth Strategy with Announcement of CE Mark in Europe
Both the Lantern® and OrthAlign Plus® platforms are now CE marked and available for sale.
Clinical Trials
Nectero Therapeutics Reports Two-Year Safety and Efficacy Data from First-in-Human Trial for Treatment of Small- to Medium-Sized Abdominal Aortic Aneurysms
The results were presented at Charing Cross 2026 by Dr. Andrew Holden during a session on Abdominal Aortic Aneurysm (AAA) disease management
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
Biotechnology News
Atelerix launches STORganoid cryo-free preservation solution for complex 3D cell models
Ambient-temperature preservation solution enables reliable storage and shipment of organoids and spheroids, to support growing adoption of New Approach Methodologies
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
Mergers & Acquisitions
PathoQuest, a Kurma Partners portfolio company, announces a definitive agreement to be acquired by Charles River Laboratories
PathoQuest was built and supported by Kurma Partners and the Pasteur Institute and based on the groundbreaking work of Prof. Marc Eloit
January 12, 2026
Philips agrees to acquire SpectraWAVE Inc., advancing next-generation coronary intravascular imaging and physiological assessment with AI
Philips offers one of the most comprehensive image-guided therapy portfolios in the industry, providing solutions for visual guidance during minimally invasive procedures and image-guided therapy devices designed to enhance procedural efficiency and improve patient outcomes
December 15, 2025
Earned Acquires OJM Group
Deal marks wealth firm’s fifth acquisition in 2025, building a comprehensive offering to address every financial need of healthcare professionals
December 9, 2025
Montagu and Kohlberg to Acquire Teleflex Medical OEM in a Carve-out Transaction
For over 40 years, Teleflex Medical OEM has developed and supplied custom-engineered interventional catheter components and sub-assemblies, as well as surgical fibers and sutures, used across fast-growing treatment areas – including structural heart, neurovascular, electrophysiology and urology – that rely on advanced materials and precision manufacturing to improve surgical outcomes and patients’ lives.
December 9, 2025
Funding
Wellpoint Invests More Than $2 Million to Strengthen Community-Based Care Across Arizona
March 16, 2026
Investments support seniors, people with disabilities, family caregivers, and the direct care workforce statewide
Abram Scientific Secures $11.75M Series A Funding Led by Octapharma AG
February 24, 2026
Financing will accelerate the development of proprietary portable diagnostic platform, CoagCareTM, to enhance patient care for bleeding disorders & critical care medicine
Industry Expert Bylines
HTM’s next frontier: AI, intelligent operations, and tech-driven resilience in 2026 | By Neil de Crescenzo, Chief Executive Officer at TRIMEDX
February 4, 2026
In this ever-changing healthcare landscape, prioritizing data-driven decision-making and proactively adopting advanced technologies will position health systems to achieve lasting success in 2026 and the years ahead
Digital Pathology Reaches an Inflection Point as AI Targets Workflow Gaps | By Yair Rivenson, PhD Founder and CEO, Pictor Labs
December 3, 2025
Laboratories face mounting pressure to modernize imaging, preserve tissue, and reduce sequencing failures as adoption continues to move at a glacial pace
FIZE Medical Launches 5,000-Patient Retrospective Study to Further Establish the benefits of using FIZE kUO in managing ICU patients’ Hemodynamic status
December 1, 2025
By continuously capturing renal function patterns, the study aims to demonstrate how FIZE kUO® can provide data for early signs of instability that are often missed by intermittent measurements
FDA Medical Device Updates
Market Reports
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity
First and only FDA-approved therapy for the treatment of acquired hypothalamic obesity, a rare disease characterized by accelerated and sustained weight gain caused by hypothalamic injury or dysfunction
March 19, 2026
Centauri Therapeutics granted FDA QIDP status for CTX-187 treatment of Gram-negative bacterial infections
Dr. Debra Barker, Chief Medical Officer, Centauri Therapeutics, said: “This designation from the FDA will be invaluable as we continue to advance toward first in-human trials for CTX-187. The recognition of the potential value of our technology further underpins our belief in its potential to transform treatment paradigms for Gram-negative bacterial infections, filling an urgently needed gap in the market for new and effective treatment options for clinically vulnerable patients.”
March 10, 2026
Executives
SynerFuse® Announces VP of Regenerative Medicine: Dr Adeel Khan
“We are pleased to be able to bring Dr. Khan into our leadership team. He brings a strong blend of clinical, scientific, and strategic insight to SynerFuse® that will help us in our mission to provide relief to people afflicted with chronic low back and leg pain,” said SynerFuse® CEO and Founder Justin Zenanko.
March 24, 2026
Abselion Appoints Dale Gordon as Chair
Bioprocessing leader to drive continued commercial development and international expansion
March 23, 2026
Philips proposes new appointment and re-appointments to its Supervisory Board and CEO re-appointment
The Supervisory Board will submit to the Annual General Meeting of Shareholders 2026 a proposal to appoint John DeFord (American, 1962) as a new member of the Supervisory Board.
March 23, 2026
Advancements In Imaging
PreciseOnco research consortium awarded EUR 14.9 million IHI grant to drive breakthroughs in precision cancer treatment
Co-funded by the EU’s Innovative Health Initiative (IHI), the Philips-coordinated research consortium will combine advanced medical imaging, robotic guidance technologies, and AI to standardize and enhance the precision of minimally invasive cancer treatments
February 3, 2026
New Peer-Reviewed Study Validates AISAP’s AI Ability to Detect Major Heart Disease from a Single Ultrasound View
Retrospective Analysis of Over 120,000 Echocardiographic Studies Provides Clinical Evidence of Diagnostic Accuracy for Heart Failure and Valvular Disease
February 3, 2026
Arineta Reports | Yuma Cardiology Practices Partner to Bring Advanced Imaging to Underserved Patients in Arizona with Arineta’s SpotLight™
The joint effort expands access to advanced cardiac imaging with the highest performance CT in Arizona for high-risk and underserved populations, including seniors, Native American communities, and lower-income residents.
November 24, 2025
Hospitals In the News
Kauvery Hospital, Alwarpet Performs One of the World’s First TAVR-in-TAVR-in SAVR with Bioprosthetic Valve Fracture in 78-Year-Old
The advanced transcatheter intervention was undertaken to treat a repeatedly failing heart valve in a patient with a long and challenging history of aortic valve disease
February 3, 2026
Texas Cardiac Arrhythmia Institute First in U.S. to Implant FDA-Approved Novel Defibrillation Lead
The new technology is the world’s smallest, catheter-delivered defibrillation lead
February 2, 2026
St Luke’s Hospital in Dublin starts ASBRT Treatments Using Raypilot System
Last Friday, the treatment of the first patient was successfully completed with a team from Micropos Medical present on site
January 28, 2026
Non-Profit News
In 2026, Surging Health Care Costs To Shape Employer Health, Well-being Strategies, Says Business Group on Health’s ‘Trends to Watch’
Recommended employer actions include need for disruption, heightened scrutiny of vendor partners, sharper focus on preventive care and chronic condition management
December 3, 2025
American Liver Foundation Hosts National Legacy Gala Honoring Leaders in Liver Health
For more information about ALF, visit www.liverfoundation.org. If you have any questions or concerns regarding liver disease, call the helpline at 1-800-Go-LIVER (800-465-4837) Monday through Friday from 9 a.m. to 5 p.m. ET.
October 9, 2025
May Benefit Women with Dense Breasts
The study cohort included 2,978 participants (mean age 56.8 years). The women were mostly postmenopausal, and 82% had category C breast density. Approximately 80% of participants had no family history of breast cancer, and 98% had no personal history of breast cancer.
September 23, 2025
Healthcare: Understanding the Business Side of the Industry and Its Implications
Swypes Reports Phone Hygiene Is Healthcare’s Overlooked First Line of Defense
Swypes is calling attention to a critical gap in healthcare hygiene: although hospitals and nursing homes enforce strict infection-control protocols, CDC figures and published research suggest mobile phones remain an overlooked risk in daily care settings, with one meta-analysis finding contamination on 84.5% of healthcare workers’ devices
March 23, 2026
TOP 4mental health app developers ranked by user growth
Choosing the right partner to build a digital health product is a high-stakes decision that goes far beyond checking boxes on a list of technical requirements
March 23, 2026
TransDental Is Fixing the Billing Problem That’s Quietly Draining Dental Practices Dry
TransDental is a dedicated dental billing company serving independent practices and group offices across the United States
March 18, 2026
Healthcare Interoperability vs Health Information Exchange (HIE): What’s the Difference in Practice
Health information exchange and healthcare interoperability are related but not interchangeable. One focuses on moving data across boundaries. The other ensures that data can be used meaningfully inside systems.
March 16, 2026
