Latest news with #CE-marked
Business Wire
5 days ago
- Business
- Business Wire
VIVOLTA and Fibrothelium partner to manufacture SimplySilk® membrane for Guided Bone Regeneration
WAALRE, Netherlands--(BUSINESS WIRE)--VIVOLTA, the medical electrospinning solutions provider, has signed a long-term partnership with Fibrothelium, a specialist in silk protein biomaterials, to manufacture electrospun components for use in Fibrothelium's SimplySilk® membrane – an advanced electrospun silk membrane designed to support guided bone regeneration (GBR) in oral surgery. Under the agreement, VIVOLTA will serve as the exclusive contract manufacturer of SimplySilk® membrane electrospun components, leveraging its fully automated MediSpin™ technology to produce the electrospun membranes at commercial scale while ensuring consistent quality and regulatory compliance. SimplySilk® membrane is a resorbable barrier membrane intended to facilitate bone regrowth in dental implants, periodontal procedures and cranio-maxillo-facial surgery. Developed with Fibrothelium's proprietary silk fibroin technology, the membrane features a unique multi-layer design, ensuring prolonged barrier function when clinically needed. Two porous, fleece-like outer layers promote rapid soft tissue integration, while an optional compact silk fibroin film core slows biodegradation and enhances mechanical stability. Unlike conventional GBR membranes derived from animal collagen, SimplySilk® membrane is entirely free of animal tissue, eliminating the risk of pathogen transmission and supporting extended degradation profiles. Fibrothelium's biocompatible PureSilk® material promotes safe, predictable healing of bone defects. The membrane naturally resorbs over time, removing the need for patients to undergo a second surgery to remove it once the healing process is complete. Global demand for regenerative dental solutions is rising, fueled by growth in dental implant procedures and the increasing prevalence of periodontal disease. The GBR membrane market was estimated at roughly $520 million in 2024 and is forecast to nearly double to $950 million by 2033, growing at about 7.5% annually. This growth is driven by the need for advanced biomaterial membranes that improve clinical outcomes in implantology and oral surgery. 1 Studies indicate that over 50% of dental implant patients require some form of bone grafting or GBR to rebuild lost bone. 2 With implant procedures on the rise worldwide, clinicians are seeking high-performance barrier membranes that provide reliable regeneration of bone tissue while minimizing complications. SimplySilk® membrane's long-term barrier function and animal-tissue-free composition positions it as a timely innovation in this expanding market. 3 SimplySilk® membrane is a CE-marked Class III medical device and is commercially available in Europe. Ongoing clinical studies demonstrate excellent performance in routine clinical applications. In parallel with its MDR recertification, Fibrothelium is preparing for FDA submission, with U.S. market approval targeted for 2027. Denis Leissing, CEO of VIVOLTA, said: 'This partnership with Fibrothelium underscores VIVOLTA's ability to support innovators from concept through commercialization. We are excited to apply our electrospinning expertise and MediSpin™ manufacturing platform to scale up SimplySilk® membrane production. 'By combining Fibrothelium's groundbreaking silk biomaterial with our unique high-volume electrospinning capabilities, we will help bring this advanced GBR membrane to dental patients worldwide. Our team is proud to enable a new animal-tissue-free solution that can improve healing and outcomes in regenerative procedures.' Hans Leemhuis, CEO of Fibrothelium, commented: 'Partnering with VIVOLTA marks a key milestone in scaling the production and the global availability of our SimplySilk® membrane. Vivolta's proven know-how in electrospun medical products and its state-of-the-art MediSpin™ system give us great confidence in the quality, reproducibility and scalability of our product as we ramp up production. 'We look forward to delivering our SimplySilk® membrane to clinicians worldwide as a safe, effective new animal-tissue-free option for regenerative procedures that supports optimal tissue regeneration and patient care.' About VIVOLTA VIVOLTA is a fully integrated medical electrospinning solutions provider devoted to the development and high-volume manufacturing of electrospun medical products for its clients. Vivolta offers end-to-end services from material R&D and product development through clinical-scale and commercial manufacturing, using its proprietary MediSpin™ platform to produce nanofiber-based medical devices and components with high precision and unwavering quality. About Fibrothelium Fibrothelium GmbH (Aachen, Germany) is a biomedical company specializing in silk fibroin-based biomaterials for clinical use. A spin-off from RWTH Aachen University in 2017, Fibrothelium has core expertise in isolating and purifying highly biocompatible, bioresorbable fibroin proteins from natural silk without the use of toxic solvents. This fibroin solution is the backbone of a proprietary process to create advanced regenerative products, enabling the transformation of silk fibroin into various forms and functions. Fibrothelium's technology is used to develop and manufacture next-generation resorbable implants – including the SimplySilk® membrane – that support tissue repair and regeneration in a safe and sustainable way. Sources: Verified Market Reports – GBR Membrane Market Insights 2025. Cha HS, Kim JW, Hwang JH, Ahn KM. Frequency of bone graft in implant surgery. Maxillofac Plast Reconstr Surg. 2016 Mar 31;38(1):19.
Business Wire
29-07-2025
- Health
- Business Wire
INBRAIN Neuroelectronics Reports Interim Analysis of First-in-Human Study of Graphene Brain-Computer Interface
BARCELONA, Spain--(BUSINESS WIRE)-- INBRAIN Neuroelectronics today announced the interim analysis of findings from the world's first-in-human clinical study of its graphene-based brain-computer interface (BCI) technology. The study, sponsored by the University of Manchester and conducted at the Manchester Centre for Clinical Neurosciences (Northern Care Alliance NHS Foundation Trust), is evaluating the safety and functional performance of graphene-based electrodes when used during surgery for resection of brain tumors. The primary objective of the study (NCT06368310) is to assess the safety of INBRAIN's brain-computer interface (BCI) during brain tumor surgery. Secondary objectives include evaluating the quality of neural signals captured by the device, its ability to deliver targeted brain stimulation, the consistency of its performance throughout the procedure, and its overall suitability for use in the neurosurgical operating room. A total of 8 to 10 patients are expected to be enrolled to validate the safety and functional performance of the graphene-based BCI. The study design included an interim analysis after the first four patients had been recruited to ensure patient safety and data quality. Interim analysis of the results from the first cohort of four patients enrolled in the study demonstrated no device-related adverse events, a key component of the primary endpoint of the study. During awake language mapping, the device captured distinct high gamma activity linked to different phonemes, the smallest units of sound in speech, showcasing exceptional spatial and temporal resolution, even with micrometer-scale contacts. The ultra-thin, sub-micrometer graphene electrodes also proved compatible with commercially available, CE-marked electrophysiology systems, reliably recording real-time brain signals throughout the surgical procedures. 'The ability to detect high-frequency neural activity with micrometer-scale precision opens new possibilities for understanding brain-tumor interactions and broader brain function in neuro-related disorders,' said Mr. David Coope, Chief Investigator and Consultant Neurosurgeon at the Manchester Centre for Clinical Neurosciences, the Geoffrey Jefferson Brain Research Centre and the University of Manchester. 'This technology could be transformative, not only for improving surgical outcomes but for unlocking new treatment pathways.' Throughout the procedures, INBRAIN's BCI enabled high-resolution brain signal monitoring, addressing one of the most pressing challenges in neurosurgery: achieving precise tumor removal while preserving essential functions such as speech, movement, and cognition. The device was used in parallel with standard clinical monitoring tools, maintaining consistent performance across the surgical window. 'This milestone demonstrates that graphene-based brain-computer interfaces can be deployed in the operating room and deliver a level of neural fidelity not achievable with traditional materials,' said Carolina Aguilar, CEO and Co-Founder, INBRAIN Neuroelectronics. 'We're moving toward a future where neurosurgeons and neurologists can rely on real-time, high-definition brain data to guide personalized interventions.' INBRAIN's platform is powered by ultra-flexible, thin-film graphene semiconductors that conform more precisely to the brain surface than conventional strip electrodes. The BCI features high-density, multiscale, bidirectional contacts for superior decoding and modulation, and reduced graphene oxide (rGO) nanoporous matrices that enhance sensitivity and signal resolution. In preclinical studies, the GCI significantly outperformed platinum-based electrodes in detecting high gamma frequencies (80–130 Hz) critical for speech decoding, with statistical significance (p < 0.01). Clinical Advantages Graphene technology offers several benefits for neurosurgical procedures. It enhances surgical precision by enabling smaller and more densely packed electrodes, allowing surgeons to define and preserve critical functional areas during tumor resection. Its flexibility enables accurate decoding and mapping in anatomically complex or hard-to-access brain regions, including the walls of the tumor resection cavity. Additionally, the device's ability to decode high-frequency activity offers huge scientific opportunities including the potential to reveal in situ interactions between glioma cells and neurons, offering potential insights into new therapeutic targets for halting tumor progression. 'We're not delivering incremental innovation, we're enabling entirely new capabilities,' said Kostas Kostarelos, Co-Founder of INBRAIN and Chief Scientific Investigator of the study and Professor of Nanomedicine at the University of Manchester, the Catalan Institute of Nanoscience and Nanotechnology (ICN2) in Barcelona, and Programme Lead for the Next Generation Therapeutics Theme of the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC). 'This convergence of advanced materials science, neuroscience, and AI is shaping the future of real-time, precision neurology.' As the first safety study of a graphene-based neural interface in humans, this study marks a foundational step toward the development of BCI therapeutic systems for chronic neurological diseases, pioneering a new era of real-time, precision neurology. About INBRAIN Neuroelectronics INBRAIN Neuroelectronics is pioneering real-time precision neurology with the world's first graphene-based brain-computer interface (BCI) therapeutics platform. Our technology combines precise BCI decoding with micrometric modulation to deliver adaptive, personalized treatments for conditions such as Parkinson's disease, epilepsy, and stroke rehabilitation. By providing continuous real-time monitoring and autonomous therapy adjustments, our AI-driven platform maximizes therapeutic outcomes while minimizing side effects. Through strategic collaborations, including with Merck KGAa and our subsidiary INNERVIA Bioelectronics, we are extending our innovative solutions to peripheral nerve and systemic disease applications, unlocking the potential of neurotechnology and bioelectronics. For more information, visit and follow us on LinkedIn. About Northern Care Alliance (NCA) Northern Care Alliance NHS Foundation Trust provides hospital and community healthcare services in Salford, Oldham, Bury and Rochdale. Our dedicated team of around 20,000 staff delivers high standards of care and experience excellence to over one million people across Greater Manchester and beyond, working together to save lives and improve lives. More information about the NCA can be found at About the National Institute for Health and Care Research (NIHR) The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by: Funding high quality, timely research that benefits the NHS, public health and social care; Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services; Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research; Attracting, training and supporting the best researchers to tackle complex health and social care challenges; Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system; Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries. NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK international development funding from the UK government. About the NIHR Manchester Biomedical Research Centre (BRC) The NIHR Manchester Biomedical Research Centre (BRC) transforms scientific breakthroughs into diagnostic tests and life-saving treatments for patients. NIHR Biomedical Research Centres (BRCs) are collaborations between NHS organisations and universities. They bring together academics and clinicians to translate scientific discoveries into potential new treatments, diagnostics and technologies. Manchester BRC is hosted by Manchester University NHS Foundation Trust and The University of Manchester – in partnership with five NHS trusts; Blackpool Teaching Hospitals NHS Foundation Trust, The Christie NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, and the Northern Care Alliance NHS Foundation Trust. About The University of Manchester The University of Manchester is recognised globally for its pioneering research, outstanding teaching and learning, and commitment to social responsibility. The Russell Group institution is ranked the 6 th best university in the UK and 38 th in the world (Academic Ranking of World Universities). A truly international university, its community includes more than 44,000 students, 12,000 staff, and 500,000 alumni from 190 countries. Together, they are tackling the world's biggest challenges – the University's social and environmental impact is ranked in the top ten globally (Times Higher Education Impact Rankings). The University is a powerhouse of research and discovery; 25 Nobel laureates are among its former staff and students; and it was ranked fifth for research power – the quality and scale of research and impact – in the UK government's Research Excellence Framework (REF) 2021. The institution is the most popular in the UK for undergraduate applications (UCAS 2021 cycle), and it is the it is the most targeted university by the UK's leading employers (The Graduate Market, 2023).
Business Wire
15-07-2025
- Business
- Business Wire
Varian Introduces IntelliBlate in Europe, Advancing an Integrated Microwave Ablation Solution for Image-Guided Cancer Therapy
PALO ALTO, Calif.--(BUSINESS WIRE)--Varian, a Siemens Healthineers company, today announced the European launch of IntelliBlate, its next generation microwave ablation solution, for the treatment of soft tissue tumors. Now CE-marked, IntelliBlate represents a pivotal milestone in expanding access to an integrated, intuitive, and minimally invasive treatment option for clinicians and patients across Europe. Designed to provide clinicians with greater predictability, precision, and control, IntelliBlate serves as the cornerstone of a future-focused, integrated ecosystem for microwave ablation. This therapeutic device complements the Siemens Healthineers' suite of imaging and software solutions including: myAblation Guide for planning and post-procedural confirmation software, myNeedle Laser guidance system that enhances placement with a CT scan, and ultrasound for assessment, placement, and monitoring during treatment. With the addition of IntelliBlate, the Varian and Siemens Healthineers' offerings allow clinicians to plan, place, treat, monitor, and confirm ablation therapy in one environment, simplifying workflow and supporting greater confidence in targeting and treatment. IntelliBlate delivers the versatility to meet the unique clinical needs of each patient. It produces large, controlled spherical ablation zones for predictable treatment delivery. A novel feature, the Ximitry probe's thermocouples provide continuous temperature monitoring inside and outside the ablation zone, allowing clinicians to observe real-time temperature changes and make informed decisions. The system provides two generators in one system making it compact and portable. The intuitive interface with fast set up and pre-programmed ablation zone settings makes the IntelliBlate a streamlined solution that helps reduce procedural barriers. Following receipt of its U.S. FDA market clearance in 2024, IntelliBlate enters the European market at a time of growing clinical evidence around thermal ablation. The COLLISION trial 1, a large international phase 3 study, published in The Lancet Oncology, demonstrated that thermal ablation can be as effective as the gold standard, surgical resection alone, in treating small-size colorectal liver metastases (CRLM) while resulting in significantly fewer complications, comparable overall survival, and shorter hospital stays for patients. 'The results of the COLLISION trial mark a milestone in how we think about ablation,' said Franck Facchini, President of Interventional Solutions at Varian. 'We have reached the point where the clinical evidence unrefutably supports the use of thermal ablation as a first-line treatment option, and not just an option for patients who cannot undergo surgery. IntelliBlate was designed to meet this shift in care, combining precision with intelligent software and imaging in a solution that fits seamlessly into modern cancer care workflows.' IntelliBlate will be introduced to the European clinical community in September at CIRSE 2025, the leading European Congress for interventional radiology in which Varian and Siemens Healthineers will offer hands-on demonstrations and educational sessions to support training, best practice and early clinical adoption. IntelliBlate represents a more targeted, less invasive approach to cancer care, offering new options to clinicians and new hope to patients. It reflects Varian's commitment and investment to becoming a leading innovator in interventional solutions and envisioning a world without the fear of cancer. Varian's journey with Siemens Healthineers is just getting started; together, we are committed to the continued development of a smart, integrated approach that connects innovative therapy technologies and image-guided solutions. © 2025 VARIAN MEDICAL SYSTEMS, INC. All trademarks are the property of their respective owners. About Varian At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help care providers around the globe treat millions of patients each year. Today, as a Siemens Healthineers company, we support every step of the cancer care journey – from screening to survivorship. From advanced imaging and radiation therapy to comprehensive software and services, to interventional radiology, we are harnessing the power of our perspective while also pursuing clinical research to create a more efficient, and more personalized care pathway. Because, for cancer patients everywhere, their fight is our fight. For more information, visit QR700024726
Yahoo
30-06-2025
- Health
- Yahoo
Medical Displays Market to Hit US$3.45 Billion by 2030 -- A Strategic Growth Lever for Imaging OEMs, Hospital Chains & Surgical Tech Innovators
DELRAY BEACH, Fla., June 30, 2025 /PRNewswire/ -- What's powering a US$3.45 billion opportunity? The global medical display market, valued at US$2.50 billion in 2024, stood at US$2.64 billion in 2025 and is projected to advance at a resilient CAGR of 5.5% from 2025 to 2030, culminating in a forecasted valuation of US$3.45 billion by the end of the period. This growth is driven by rising chronic disease burdens, an aging global population, and increased investment in high-resolution diagnostic imaging. As healthcare infrastructure modernizes and surgical precision becomes non-negotiable, medical displays are transforming from passive viewing tools into strategic clinical assets. Download PDF Brochure: Why are medical displays becoming the backbone of modern diagnostics? Medical displays are driving measurable improvements in diagnostic accuracy and surgical outcomes. With applications spanning radiology, pathology, telemedicine, and hybrid ORs, these displays enable real-time imaging clarity, higher contrast, and multimodal integration—all critical for precision-based care. Diagnostic displays alone held the largest market share in 2024 due to the need for faster, more confident clinical decisions. Color displays continue to dominate due to their ability to visualize soft tissue contrast with precision—vital in chronic disease detection and surgical planning. What clinical and operational gaps are these displays solving? In hybrid ORs and high-volume diagnostic centers, the ability to view multiple imaging streams (MRI, ultrasound, fluoroscopy) on a single integrated display enables faster decision-making and fewer errors. These displays streamline workflows, improve surgical accuracy, and allow cross-functional teams to collaborate in real-time. They're not just helping visualize patient data—they're accelerating care delivery. Where is growth accelerating—and why now? Emerging markets are presenting high-growth potential. Regions like India, Brazil, Southeast Asia, and the Middle East are witnessing rapid healthcare infrastructure expansion. Hospital modernization, government incentives, and increased access to capital are fueling demand for advanced imaging displays in diagnostics and surgery. Request Sample Pages : Who's leading the way—and how are they scaling? Barco dominates with MDR-certified, CE-marked displays and a global footprint. EIZO, Sony, LG, Novanta, FSN Medical, and STERIS are expanding with AI-ready, 4K/8K displays optimized for diagnostics and ORs. Companies like Jusha Medical and COJE Displays are building competitive momentum through regional specialization and price-performance balance. Key strategies: product launches, regional expansions, compliance certifications, and hybrid OR integrations. What's slowing adoption—and what unlocks it? Barriers: High upfront costs of 4K/OLED/AI-integrated displays and rising adoption of refurbished systems—especially in cost-sensitive ROI justification frameworks, outcome-based pricing, clinical training infrastructure, and standardization through regulatory certifications. Strategic investments in outcome transparency and clinician training can shift displays from CapEx resistance to ROI-positive assets. What C-level executives should ask next: Instead of asking "Should we invest in better displays?", decision-makers should ask: What clinical risks do outdated displays pose to our diagnostic accuracy and brand reputation? Where can we reallocate budgets to support hybrid OR conversions with high-resolution display systems? How do we scale telemedicine offerings without compromising visual quality and patient confidence? Who can we partner with to localize medical display innovation for emerging markets? Why is display standardization across facilities becoming a strategic necessity for hospital networks and OEMs? Final Thought: See Clearly. Grow Strategically. The medical displays market isn't just growing—it's enabling growth for hospitals, OEMs, and surgical innovators. In an environment where outcomes are everything, the clarity and speed of medical imaging define the quality and cost-efficiency of care. Displays that deliver precision don't just support diagnostics—they drive decisions, partnerships, and profit. For more information, Inquire Now! Related Reports: Digital Stethoscopes Market Single Use Surgical Instruments Market AI in Remote Patient Monitoring Market Smart Pills Market Pharmacy Automation Market Get access to the latest updates on Top Companies in Medical Display and Medical Display Market Size About MarketsandMarkets™: MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. 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Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts. To find out more, visit or follow us on Twitter , LinkedIn and Facebook . Contact:Mr. Rohan SalgarkarMarketsandMarkets™ INC.1615 South Congress 103, Delray Beach, FL 33445USA: +1-888-600-6441Email: sales@ Our Website: Logo: View original content to download multimedia: SOURCE MarketsandMarkets Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Time Business News
06-06-2025
- Health
- Time Business News
Evolution of Veterinary Surgical Tools: From Scalpels to Precision
'Would you trust 18th-century tools for your pet's life-saving surgery?' Shockingly, early veterinarians did just that, using repurposed human instruments on animals. Today, 90% of veterinary surgeries rely on specialized tools that have transformed animal care. Let's explore this remarkable journey from basic implements to today's technological marvels. Did you know? The global veterinary surgical tools market is projected to reach $1.8 billion by 2030, reflecting growing advancements in animal healthcare. Adapted human tools: Farriers and early vets used modified human scalpels and bone saws No sterilization: Boiling water was the only 'cleaning' method Brutal procedures: Animals often endured surgeries without proper anesthesia Veterinary Tools Through the Ages Era Key Tools Success Rate Major Limitations 1800s Rustic metal tools 40% High infection risk 1950s Standardized instruments 65% Limited specialization 2020s HD laparoscopic systems 95%+ Higher cost Species-specific designs: Unique tools for canine, feline, and exotic animals Minimally invasive tech: Laparoscopic and laser systems reduce trauma Advanced sterilization: Autoclaves and single-use instruments prevent infections Real-time imaging: High-definition endoscopes provide internal visualization of animal surgical tools Laser scalpels: For bloodless incisions Electrosurgical tools: Combine cutting and cauterization Microscissors: For delicate tissue procedures Vascular clamps: Designed for animal circulatory systems Micro-forceps: For ophthalmic and neurosurgeries Self-retaining retractors: Improve surgical access 3D surgical cameras: Provide depth perception Fluoroscopy units: For real-time imaging Surgical headlamps: With adjustable focus and intensity When buying veterinary surgical instruments online, prioritize: Material quality: Surgical-grade stainless steel or titanium Ergonomics: Reduce surgeon fatigue during long procedures Reputation: Choose suppliers with veterinary instruments for specific experience for specific experience Certifications: Look for FDA-cleared or CE-marked tools Critical Warning: Avoid counterfeit instruments, always verify supplier credentials, and request material certifications. Robotic-assisted systems: Already in use at leading veterinary schools 3D-printed instruments: Custom-designed for rare anatomical cases AI-guided diagnostics: Improving preoperative planning Smart instruments: With built-in pressure sensors and feedback Specialization matters: Modern tools are designed for specific species and procedures Technology enhances outcomes: Minimally invasive techniques reduce complications Quality saves lives: Invest in proper instruments and maintenance Stay informed: Continuing education is crucial as technology evolves Ready to upgrade your toolkit? Explore our selection of FDA-approved veterinary surgical instruments designed for precision and durability. TIME BUSINESS NEWS
