Fractures, Compression

Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures. La Ciotat, FRANCE, June 12, 2024 /PRNewswire/ -- Avicenna.AI, a leading medical imaging AI company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for CINA-VCF, a triage and notification AI tool that detects unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans. Often resulting from the deterioration of bone structure (osteoporosis), VCFs can cause significant pain, deformity, and height loss. In the USA, approximately 750,000 adults suffer from osteoporotic VCFs each year, but around two-thirds of those go undetected or unreported. The CINA-VCF algorithm identifies and prioritizes vertebral compression fractures detected during routine CT scans for patients undergoing medical imaging for entirely different health conditions, notifying clinicians within seconds. The tool was validated on 474 CT scans (performed for other clinical indications than for VCF evaluation) acquired on 38 different scanner models from four different manufacturers, achieving excellent sensitivity and specificity results. By facilitating the early detection of vertebral compression fractures, CINA-VCF aims to help prevent further bone density loss and additional fractures, enhancing patient care and outcomes. The tool enables vertebral fractures to be addressed before they multiply, reducing the risk of complications and potentially lowering medical expenses. "Osteoporosis is a global burden affecting millions, especially postmenopausal women, and often goes unnoticed until symptoms like pain and loss of mobility appear," said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. "By detecting vertebral compression fractures early, we aim to help patients maintain better mobility and independence, enhance the well-being of those at risk, and reduce the burden on healthcare systems worldwide. We have also partnered with the International Osteoporosis Foundation to increase awareness about this debilitating condition." CINA-VCF is the latest tool from Avicenna.AI to secure FDA clearance, joining its AI solutions for automatic detection of a host of conditions from CT imaging. It is also the company's second tool FDA-cleared for incidental findings, alongside CINA-iPE, which identifies unsuspected cases of pulmonary embolism in oncology patients. The company's other AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and quantification of stroke severity (CINA-ASPECTS). All of Avicenna.AI's AI tools are seamlessly integrated into radiologists' clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists. About Avicenna.AI Founded in 2018, Avicenna.AI specializes in providing healthcare AI solutions that utilize deep learning to identify, detect, and quantify severe pathologies from CT medical images. Co-founded by Cyril Di Grandi, a successful entrepreneur who previously co-founded Olea Medical, and Dr. Peter Chang, an internationally recognized radiologist, and an expert in AI and deep learning, Avicenna.AI aims to accelerate therapeutic decision-making processes and enhance patient outcomes through its AI-based radiology solutions. For additional details, stay connected with us on social media and explore Avicenna.AI's website at . For more information, contact: Stéphanie Bellavia, Marketing Manager, Avicenna.AI Email: [email protected] SOURCE Avicenna.AI

Aidoc aiOS™ integration across 13 hospitals focuses on enhancing clinical outcomes and streamlining workflow with access to 17 FDA-cleared AI algorithms CLEVELAND, June 12, 2024 /PRNewswire/ -- University Hospitals (UH) has announced a major advancement in its AI strategy with the deployment of Aidoc's comprehensive AI platform (aiOS™) across 13 of its hospitals and dozens of its outpatient locations. This initiative marks a significant leap forward in leveraging cutting-edge technology for superior patient outcomes. Continue Reading Image of University Hospitals Medical Center Campus in Cleveland, Oh. (PRNewsfoto/Aidoc) University Hospitals Logo (PRNewsfoto/Aidoc) Driven by a commitment to provide the highest standard of care, UH sought a standardized, hyper-accurate AI platform that could be seamlessly integrated across its network of academic hospitals and outpatient locations. Having utilized AI in various small-scale applications, UH chose to expand its capabilities with Aidoc to empower care teams with the information they need to address some of today's most pressing medical issues. Patients at UH will benefit from faster diagnosis and treatment of acute conditions such as pulmonary embolism, aortic dissection, vertebral compression fracture and pneumothorax. When a patient arrives at a UH facility and undergoes a CT scan for an injury or pain, Aidoc's AI analyzes the scan using its comprehensive algorithms. The technology identifies both expected and unexpected findings, helps physicians prioritize urgent cases and ensures all flagged conditions are reviewed by the care team. Aidoc's AI facilitates communication between the care team to enhance collaboration and speed up treatment. Key Benefits of Aidoc for University Hospitals Seamless integration across the entire health network Immediate access to critical patient information Expedited care and improved patient outcomes Access to all 17 FDA-cleared AI algorithms for triage, quantification and care coordination "Today's care delivery is incredibly complex with numerous moving parts," shared Dr. Donna Plecha, Chair of Radiology at University Hospitals." Aidoc's AI technology assists our radiologists in evaluating various patient images, allowing our clinicians to access precise, actionable data quickly. The AI technology enables our care teams to be more accurate and efficient leading to even more exceptional care for our patients." The agreement leverages Aidoc's proprietary aiOS™, a groundbreaking platform that addresses common AI implementation challenges such as integrating with existing IT systems, ensuring EHR compatibility, and managing data and reporting. This comprehensive approach ensures that UH can provide leading-edge care while maintaining operational efficiency and clinical excellence. "We are thrilled to collaborate with University Hospitals to drive healthcare innovation through our AI solutions," said Elad Walach, CEO, Aidoc. "University Hospitals' visionary approach to healthcare and dedication to integrating technology sets a new standard for patient care. UH is not only enhancing care coordination and streamlining workflows but also ensuring every patient receives the precise, timely and exceptional care they deserve. UH's commitment to medical ingenuity and excellence is truly transformative." By integrating Aidoc's AI platform, University Hospitals ensures seamless deployment and minimal technical challenges, allowing for a collaborative approach to continuous monitoring and governance. This partnership not only enhances patient safety and care but also enables UH to maintain high standards in AI performance and reliability. Through this collaborative effort, UH can focus more on patient care, ensuring every patient receives the best possible treatment with the aid of AI technology. About University Hospitals Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 21 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system's flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, the Technion Israel Institute of Technology and National Taiwan University College of Medicine. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including "America's Best Hospitals" from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org. About Aidoc Aidoc is a pioneering force in clinical AI. We focus on aiding and empowering healthcare teams to optimize patient treatment, which results in improved economic value and clinical outcomes. Our clinically proven AI solutions eliminate silos, increase efficiencies, and improve outcomes by delivering critical information when and where care teams need it leading to immediate collective action. Built on Aidoc's proprietary aiOS™, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Used in more than 1,000 medical centers worldwide, Aidoc has the most FDA clearances (17) in clinical AI and its AI-based solutions cover 75 percent of patient populations, enabling physicians to make informed decisions based on real-time data. Aidoc AI is always on, running in the background to change the foreground. Visit Aidoc.com to see how we are connecting all points of care with always on AI. Photo - Logo - Logo - SOURCE Aidoc

THE HAGUE, Netherlands, June 11, 2024 /PRNewswire/ -- Amber Implants ('Amber' or 'the Company'), an innovative medical technology company developing next-generation implants for spinal injuries, today announces that it has completed enrolment of its first-in-human clinical trial with its innovative VCFix® Spinal System. The VCFix® Spinal System is the first device that does not rely on bone cement for the treatment of vertebral compression fractures. The trial was conducted at two centers in Germany with Prof. Dr. Med. Robert Pflugmacher (Orthopaedic surgeon, Kreiskrankenhaus Mechernich GmbH.) and Dr. Med. Ardeshir Ardeshiri (Neurosurgeon, Wilhelmsburger Krankenhaus Groß-Sand Hamburg) and assessed the safety and efficacy of the VCFix® Spinal System for patients suffering from osteoporotic vertebral compression fractures. The device was primarily used in stand-alone configuration without bone cement. The study enrolled 10 patients, all of whom suffered from severe disabling pain with Disability Ratings of 70% and higher. Following the procedure, typically lasting less than 20 minutes, all the patients saw maximal pain reduction with Disability Ratings reduced to 10% or less and they were able to walk freely without disability at discharge. The short-term efficacy data, as well as the performance of the device, has shown promising results and will be further assessed in the continuation of this trial. Prof. Dr. Med. Robert Pflugmacher said: "VCFix represents a remarkable innovation, significantly improving the reconstruction of fractured vertebrae". "This technology has proven to be user-friendly and has yielded exceptional short-term outcomes for our patients", added Dr. Med. Ardeshir Ardeshiri. The Company will soon begin the pivotal clinical trial for the same intended use (i.e., standalone and with and without cement) as well as test the device with a posterior fixation method for high-energy traumatic fractures. Amber is preparing for these pivotal trials in a broader European setting before the end of the year and is building towards Food and Drug Administration ('FDA') clearance for its first indication in early 2025. Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants said: "Short-term efficacy data from the study is very promising, with results even exceeding our expectations. Patients have experienced significant pain relief and regained the ability to walk without discomfort. VCFix® has the potential to be a disruptive technology for the millions of patients who suffer from vertebral fractures each year. We are now focused on preparing for pivotal trials in Europe to bring the benefits of this technology to the many more patients who would otherwise suffer from the high rate of complications associated with other treatment options available." Per year, over 8.6 million people suffer from different types of vertebral fractures. These fractures cause severe back pain, limited mobility, disability, and an increased rate of mortality. Currently, vertebral compression fractures are managed through the injection of Polymethyl Methacrylate (PMMA) bone cement into the affected vertebra and/or with multi-level posterior fixation. This can lead to side effects in up to two-thirds of patients, post-treatment. The VCFix® Spinal System is designed to restore the spine and provide maximum stability to the affected spinal segments. VCFix® offers an innovative strategy for managing a wide range of vertebral fractures, with and without cement and with and without posterior fixation. It can be used for a broad range of indications, from osteoporotic low-energy fractures to traumatic high-energy fractures, and would therefore be a disruptive technology for this patient population. The VCFix® Spinal System has received a breakthrough designation from the FDA. CAUTION: This device is exclusively for clinical investigation and no substantiated clinical benefits have been established. About Amber Implants Amber Implants is a medical technology company located in the Netherlands. Founded in 2018, the Company has developed novel spinal implants for Vertebral Compression Fractures (VCFs) and is focused on improving patient outcomes through implants that provide more natural healing and better stability. Amber Implants is committed to delivering a new generation of treatments for traumatic fractures, promising a simpler, more efficient, and safer approach to treating a broader range of fractures. SOURCE Amber Implants