Latest news with #MedicalDeviceRegulation
Yahoo
11 hours ago
- Business
- Yahoo
Avicenna.ai scoops CE marks for two AI fracture detection tools
French artificial intelligence (AI)-based medical imaging company has secured CE marks for a pair of radiologic screening tools to detect fractures from CT scans. CINA-VCF Quantix is an AI algorithm is used to detect unsuspected vertebral compression fractures (VCFs) in patients undergoing CT scans for unrelated conditions, while CINA-CSpine is designed for the detection and triage of cervical spine fractures. Both tools gained 510(k) clearance from the US Food and Drug Administration (FDA) in 2024, while the tools' receipt of CE mark follows clearance on five other AI tools in 2024 under the EU's Medical Device Regulation (EU MDR). For use in patients aged 50 and above who are undergoing patients undergoing CT scans of the chest or abdomen for other conditions, CINA-VCF Quantix automatically labels vertebrae and calculates vertebral height loss ratios in the thoracic and lumbar spine. In cases where a vertebral height loss ratio exceeds 20%–25%, a figure indicative of a moderate- to severe VCF, the algorithm generates prompts notifying radiologists to report their early findings in support of proactive patient care, Avicenna stated. co-founder and CEO, Cyril Di Grandi commented: "Osteoporotic vertebral fractures can have a profound impact on patients' quality of life. "By encouraging the reporting of VCF presence and severity, CINA-VCF Quantix has the potential to make a real difference in long-term patient outcomes." CINA-CSpine is designed to automatically flag suspected acute cervical spine fractures through radiologists' existing systems. Di Grandi continued: "The launch of CINA-CSpine in the European market marks a significant step forward in trauma care. By reducing the time between scan and diagnosis, we're helping radiologists catch cervical spine fractures faster and more reliably.' A 2023 report on AI in healthcare by GlobalData forecasts that global revenue for AI platforms across the sector will reach a valuation of almost $19bn by 2027, with the radiology field seeing some of the highest implementation of AI technologies. Research indicates that thoracolumbar fusion procedures, one of the most common spine surgery types, are in growing demand, with thoracolumbar procedures such as anterior lumbar interbody fusion (ALIF) and posterior lumbar fusion (PLF) in the US projected to see respective rises from 46,903 to 55,528 and 248,416 to 297,994 between 2020 and 2040. According to GlobalData, the spinal fusion market segment, of which thoracolumbar fusion is a part, is growing at a CAGR of 2.3% and forecast to reach a valuation of around $11.23bn by 2033. " scoops CE marks for two AI fracture detection tools" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Errore nel recupero dei dati Effettua l'accesso per consultare il tuo portafoglio Errore nel recupero dei dati Errore nel recupero dei dati Errore nel recupero dei dati Errore nel recupero dei dati
Yahoo
3 days ago
- Health
- Yahoo
Corify Care announces AI collaboration with Mayo Clinic to improve cardiac arrhythmia care
MADRID, June 3, 2025 /PRNewswire/ -- Corify Care, an AI-driven medical technology company specializing in global cardiac mapping and real-time precision guidance for the treatment of cardiac arrhythmias, announced today it has entered into a know-how agreement with Mayo Clinic. Nearly 60 million people worldwide are affected by atrial fibrillation, yet treatment outcomes for complex cases remain ineffective. More than 50 percent of ablation procedures for complex arrhythmia fail, in many cases because clinicians are unable to target the necessary region of the heart. Corify's global mapping technology now allows clinicians to pinpoint the source of an atrial fibrillation case, creating an accurate roadmap for completing a targeted ablation. As part of the collaboration, select Mayo Clinic physicians will help Corify refine its current model and make recommendations on improvements relating to useability and clinical flow. "This collaboration focuses on advancing AI-powered technology for real-time cardiac mapping and enhanced procedural guidance in arrhythmia treatment,'' said Andreu Climent, CEO of Corify Care. Corify Care's proprietary technology offers a global and efficient solution to detect, map, and manage complex cardiac arrhythmias with unprecedented speed and accuracy. Unlike traditional invasive diagnostic methods, Corify Care's system creates detailed three-dimensional maps of the heart's electrical activity — offering a faster approach to arrhythmia diagnosis and management. Ultimately this technology aims to provide more effective treatment and a reduced risk of recurrence, saving and improving more patients' lives. Recent clinical research confirmed that Corify's imageless ECGI system enables noninvasive, real-time cardiac mapping without the need for CT or MRI and can be applied across a wide range of procedures including atrial fibrillation, ventricular tachycardia, and cardiac resynchronization therapy. Corify has earned recognition across Europe for its clinical impact, winning several prestigious awards and receiving support from the European Innovation Institute of Technology. It is pursuing FDA approval after securing CE Mark certification in 2024 under the European Union's Medical Device Regulation. Since its launch, the technology has been successfully used in around 2,000 cases, with adoption continuing to grow. For more information about Corify, please visit Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research Contact: Alex Jackson (shark&minnow) aj@ (216) 245-3477 View original content to download multimedia: SOURCE Corify Care
Yahoo
30-05-2025
- Health
- Yahoo
An Introduction to the Design and Development of Medical Devices (Online Training Course: July 23-24, 2025) - Access Key Information on Documentation Management and Systems
Dublin, May 30, 2025 (GLOBE NEWSWIRE) -- The "An Introduction to the Design and Development of Medical Devices Training Course" training has been added to offering. This intensive two-day course will introduce those who are new to medical device design and development to the critical elements of the process. It has been designed to provide delegates with an insight into the tools and techniques required to design and develop a medical device and offer an essential overview of the current regulatory landscape. The importance of safety and efficacy will be covered, as will risk management and documentation. As combination products are a huge market, the programme will also address device constituent parts of combination products. Attending this event will provide delegates with a comprehensive appraisal of key aspects of this process and an opportunity to discuss the complexities involved with an experienced industry expert. Benefits of attending: Gain a comprehensive overview of the design and development process Comply with the regulatory requirements and standards Learn about design controls Review materials and biocompatibility Access key information on documentation management and systems Understand how risk should be managed Consider human factors and usability studies Certifications: CPD: 12 hours for your records Certificate of completion Who Should Attend? Design and development personnel Development engineers Quality personnel Regulatory personnel Design control professionals Documentation managers Programme managers Anyone who needs an overview of the medical device design and development process Agenda Day 1 Overview of the regulations and market routes Regulatory pathways Medical Device Directive (MDD) vs Medical Device Regulation (MDR) - key differences EU vs US (FDA) - markets to consider Medical device vs combination product (drug/device and device/drug) - which regulation applies? Device classification and the implications for your product Resources and sources The design and development process The stages of design and development Key considerations Terminology Intended use Project complexity Mandatory requirements Design and development tools Inspiration, innovation and determination Materials and biocompatibility DFx, Design for....? Manufacturing - key considerations Day 2 Design Control Appropriate design and development planning Translation of marketing requirements SMART design inputs Is a trace matrix appropriate? Meaningful design outputs Verification and validation Design reviews Design transfer Design history file vs technical file Change control Notified Bodies (NB) Risk management - what is required? What is risk management and when should it be applied? What does the guidance say? Help or hindrance? How to implement a practical risk management plan Tools and techniques to help you succeed Clinical evaluation, human factors and usability - how to comply Planning your clinical evaluation How to incorporate human factors and usability studies into your design and development process - MDR and FDA requirements User instructions Training considerations - when and who do you need to train? Formative studies Validation/summative studies SpeakerDavid Howlett Director, PharmaDelivery Solutions Howlett is the Director of PharmaDelivery Solutions Ltd. In 2003 he established the company as a highly specialised consultancy service in the field of drug delivery device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis, establishing design control systems and design verification, planning and execution, materials strategies and type III device Drug Master Files (DMFs). PharmaDelivery Solutions Ltd has provided key programme inputs in various forms including due diligence, regulatory GAP Analysis, strategic and detailed planning, implementation, mentoring and training. In addition to activities supporting commercial organizations, has been involved in the following roles; Honorary Teaching Fellow in the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester and is author/ tutor for the Pharmaceutical Industry Advanced Training (PIAT) MSc module on Inhalation dosage forms A UK national expert representing the British Standards Institute developing international standard ISO 20072:2009 for pulmonary and nasal delivery, and a committee member on other standards committees Worked with the United Nations and various national governments to develop and establish transition strategies from the use of CFC in Metered Dose Inhalers and to secure appropriate budgets from the Multi-lateral fun for the implementation of the Montreal Protocol An invited speaker at a number of international meetings and symposia on device development related subjects, including regulatory expectation, DPI development, extractables and leachables control and emerging marketsFor more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Korea Herald
28-05-2025
- Health
- Korea Herald
Lunit Launches Enhanced Lunit INSIGHT CXR4, Secures CE MDR Certification for Expanded AI Capabilities
Next-generation AI solution introduces new clinical features and broader disease detection for chest X-rays SEOUL, South Korea, May 28, 2025 /PRNewswire/ -- Lunit (KRX: a leading provider of AI for cancer diagnostics and therapeutics, today announced the official launch and CE certification under the Medical Device Regulation (MDR) of Lunit INSIGHT CXR4, its next-generation chest X-ray analysis solution. Lunit INSIGHT CXR4 is a comprehensive AI solution for chest imaging, designed to support radiologists across a wide range of clinical scenarios. It leverages advanced AI to detect 12 types of chest abnormalities—including lung nodules, pneumonia, and pneumothorax—expanding its diagnostic capabilities to include additional findings such as acute bone fractures. Trained on large-scale real-world datasets, the upgraded solution delivers improved diagnostic accuracy while supporting early detection of critical diseases. In addition to expanded disease detection, Lunit INSIGHT CXR4 introduces several new features designed to enhance clinical workflow and diagnostic support: With CE MDR certification, Lunit is now positioned to deploy INSIGHT CXR4 across Europe—offering enhanced diagnostic confidence and workflow efficiency for radiologists managing high imaging volumes. "With Lunit INSIGHT CXR4, we've gone beyond expanding detection—we've focused on what truly helps clinicians in their day-to-day workflow," said Brandon Suh, CEO of Lunit. "Features like active normal flagging and current-prior comparison are designed to reduce reading time and improve triage confidence, especially in high-volume settings. CE MDR certification is a key step toward broader adoption, and we're committed to bringing CXR4 to more hospitals worldwide." With CE MDR certification now in place, Lunit is preparing to pursue additional regulatory approvals to make CXR4 available in more regions. The company aims to further integrate its AI solutions into clinical workflows across diverse healthcare systems. CE MDR is the EU's enhanced regulatory standard for medical devices, ensuring stricter standards for safety, performance, and clinical validation. About Lunit Founded in 2013, Lunit (KRX: is a global leader in AI for cancer diagnostics and therapeutics. With a mission to conquer cancer through AI, Lunit develops AI-powered solutions for medical imaging and biomarker analysis to enable precise diagnosis and personalized treatment. Lunit's FDA-cleared Lunit INSIGHT suite supports cancer screening at over 4,800 medical institutions in more than 55 countries. Lunit clinical studies have been featured in top-tier journals—including The Lancet Digital Health and Journal of Clinical Oncology —and presented at major conferences such as ASCO and RSNA. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at
Yahoo
27-05-2025
- Business
- Yahoo
Surgify Medical secures $7.97m to advance bone surgery technology
Finnish company Surgify Medical has secured €7m ($7.97m) in Series A funding to expand the reach of its Surgify Halo technology, which aims to enhance the precision and safety of bone surgery. ZEISS Ventures spearheaded the funding round, with contributions from the European Innovation Council Fund (EIC Fund) and support from current investors, Cascara Ventures and Lednil. This capital injection will enable Surgify Medical to build on its Nordic market launch and extend its operations into the European Union (EU) and the US, where the technology is already being adopted in hospitals. According to the company, conventional surgical drills pose a risk of damaging critical soft tissues, potentially leading to severe patient injuries. The company's technology claims to address this issue by offering a safer alternative that cuts bone while safeguarding soft tissues, such as nerves and blood vessels. It not only enhances precision but also integrates into standard clinical workflows seamlessly, earning the approval of both the Medical Device Regulation (MDR) and the Food and Drug Administration (FDA). The company noted that surgeons have expressed a preference for Surgify Halo due to its easy usage. Surgify Medical CEO and co-founder Visa Sippola said: 'ZEISS brings unparalleled experience in surgical technology and a global network, while the EIC's continued support and earlier grant financing underscore the European innovation ecosystem's confidence in our solution. 'With this funding and regulatory approvals in both the EU and the US, we are well-positioned to bring our unique technology to more surgeons and patients internationally.' Beyond its immediate applications in neck, spine and head surgeries, the Surgify Halo technology holds applications in the field of robotic surgery by facilitating automated bone resection. With a total of €14m raised so far and offices in Finland, the US, Denmark and Sweden, Surgify Medical is focused on transforming bone surgery by making it faster, safer and more accurate. "Surgify Medical secures $7.97m to advance bone surgery technology" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
