Pneumothorax

- Lunit to unveil four oral presentations and three poster presentations at ECR 2024, highlighting Lunit INSIGHT's expansive capability, ranging from adaptability in different use cases to the potential to replace a human reader in mammography double-reading settings SEOUL, South Korea, Feb. 28, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the presentation of seven studies at the European Congress of Radiology (ECR) 2024, to be held in Vienna, Austria, from February 28 to March 3. Four will be presented through oral presentations and three as E-posters. Continue Reading Lunit to present seven studies featuring the Lunit INSIGHT suite at ECR 2024 In a featured oral presentation led by Dr. Carolyn Horst from King's College London, UK, 16,996 chest radiographs were retrospectively analyzed by Lunit's AI-powered chest X-ray analysis solution, Lunit INSIGHT CXR. With a maximum sensitivity of 0.94 and specificity of 0.99, among various abnormalities, researchers were able to better understand the accuracy of Lunit INSIGHT CXR at different thresholds for different use cases and abnormalities. Specifically, the AI model with high sensitivity could be appropriate for emergency findings like pneumothorax. Meanwhile, a high specificity is preferable to triage low-risk studies for reporting without missing actionable pathology. This dual approach highlighted the adaptability of Lunit's AI tool to different clinical needs in routine practice. The research also indicates that AI can offer a valuable balance between sensitivity and specificity in the analysis of common chest abnormalities, showcasing its potential to reduce radiologists' workload and enhance efficiency in reporting. In another oral presentation, a research team from Radboud University Medical Center, Netherlands, showcased their result of an independent validation of multiple commercial AI products from leading vendors. Among seven AI-powered algorithms, Lunit INSIGHT CXR achieved the highest AUC (Area Under the Curve) of 0.93 in lung nodule detection, outperforming human readers (mean AUC 0.81). The sensitivity of Lunit INSIGHT CXR reached 89%, outperforming human readers while maintaining specificity comparable to that of human readers at 80%. Four out of seven AI products, including Lunit INSIGHT CXR, showed superior performance compared to human readers. This validation provides crucial comparative performance data for AI algorithms, contributing to the ongoing discussions about the integration of AI in clinical practice. Lunit INSIGHT MMG, Lunit's AI-powered solution for early breast cancer detection, was highlighted in an award-winning study by Odense University Hospital, Denmark. Based on 249,402 consecutive screening mammograms in three distinct AI-integrated scenarios, the study assessed the software's ability to replace one or more human readers in mammography double-reading settings. Scenario 1: AI replaces the first reader, Scenario 2: AI replaces the second reader in case it agrees with the decision of the first reader, and Scenario 3: AI acts as a standalone reader. All three scenarios showed that AI-integrated screening can partially or fully replace one or both readers without affecting screening accuracy. Specifically, in Scenario 2, AI-assisted screening indicated significantly higher specificity (+0.6%) and positive predictive value (+4.7%). This groundbreaking research points towards a future where AI seamlessly integrates into double screening processes, enhancing efficiency, optimizing workflow, and maintaining stable accuracy. Additionally, Lunit plans to announce the launch of the Leeds prospective trial, a collaboration with Leeds Teaching Hospitals NHS Trust, UK. The trial, which commenced on February 19, represents the world's first prospective study of AI-powered breast reading in a symptomatic breast clinic environment. The study, scheduled to run until the end of 2025, will encompass 5,500 mammography cases of women visiting the UK Leeds Teaching Hospitals NHS Trust breast clinic. By evaluating Lunit INSIGHT MMG's efficacy in real-world clinical practice, the trial aims to revolutionize breast cancer detection and streamline diagnosis, addressing radiologist shortages. Lunit invites booth visitors at ECR 2024 to explore detailed information on the project and discuss potential future collaborations. "We are proud to present our latest research findings at this year's ECR, demonstrating the robust performance and versatility of our Lunit INSIGHT suite in various clinical settings and scenarios. Our studies also reveal that our AI can enhance the efficiency and accuracy of mammography double-reading settings, and even replace human readers in some cases," said Brandon Suh, CEO of Lunit. "We hope that these study results become a cornerstone to broaden the scope of our AI to more medical practices across the globe, and empower radiologists and patients to achieve better outcomes." Join Lunit at booth AI-15 in the EXPO X1 hall to witness how the Lunit INSIGHT suite is shaping the future of radiology across the globe. Oral presentations featuring Lunit INSIGHT at ECR 2024 include: "The performance of a commercial artificial intelligence algorithm in an external quality assurance scheme regularly used by humans in the NHS breast screening programme" (ACV 2024 Research Stage 2, February 28, 3:00-4:00 pm) "The Multi- Sixteen Thousand and Counting: Performance of an Artificial Intelligence Tool for Identifying Common Pathologies on Chest Radiographs and Report Prioritisation" (ACV 2024 Research Stage 1, February 29, 2:00-3:30 pm) "Recent development in AI for lung nodule detection" (ACV 2024 Research Stage 2, March 1, 8:00-9:00 am) "Integration of artificial intelligence (AI) in double-read population-based mammography screening: simulated replacement of one reader and beyond" (ACV 2024 Research Stage 1, March 3, 11:30-12:30 pm) Poster presentations featuring Lunit INSIGHT at ECR 2024 include: "Can artificial intelligence decrease the time to histological diagnosis of lung cancer - a retrospective-cohort study" (EPOS Area -2 Level) "Deep Learning for Chest Radiograph Evaluation in Children: Repurposed Use of a Commercially Available AI Tool Developed for Adults (EPOS Area -2 Level) "Comparison of three AI breast density tools with a human reader" (EPOS Area -2 Level) About Lunit Founded in 2013, Lunit is a deep learning-based medical AI company on a mission to conquer cancer. We are committed to harnessing AI to ensure accurate diagnosis and optimal treatment for each cancer patient using AI-powered medical image analytics and AI biomarkers. As a medical AI company grounded on clinical evidence, our findings are presented in major peer-reviewed journals, such as the Journal of Clinical Oncology and the Lancet Digital Health, and global conferences, including ASCO and RSNA. After receiving FDA clearance and the CE Mark, our flagship Lunit INSIGHT suite is clinically used in approximately 3,000+ hospitals and medical institutions across 40+ countries. Lunit is headquartered in Seoul, South Korea, with offices and representatives worldwide. For more information, please visit lunit.io. SOURCE Lunit

A Labeler project capable of diagnosing specific diseases from image readings written in natural language. Capable of identifying a total of 13 diseases with high incidence rates and importance, including fractures, pleural lesions, and pneumothorax. Recorded an accuracy of 90.39%, higher than other models, when measuring the accuracy of 10 diagnosed diseases. SEOUL, South Korea, Feb. 27, 2024 /PRNewswire/ -- On the 16th, Kakao Brain released a medical image labeler project on GitHub, capable of diagnosing specific diseases from chest X-ray image draft readings. The Labeler Project is a research and development initiative that extracts specific disease names from readings written in unstructured natural language, such as bullet format. It features the ability to identify and diagnose a total of 13 diseases with high incidence rates and importance, such as fractures, pleural lesions, and pneumothorax, based on chest X-rays. For example, when a user inputs a reading written in natural language, the reading is analyzed, and the user is notified of positive/negative results for 13 diseases. Aiming to contribute to the improvement of medical diagnoses, Kakao Brain initiated research on a labeler project that extracts specific disease names more accurately and efficiently than models previously released by other companies. This project has also been internally used to validate and study the performance of Kakao Brain's chest X-ray draft reading technology. Kakao Brain tested the accuracy of 10 diagnosed diseases, such as fractures, pneumothorax, and pulmonary edema. Kakao Brain's Labeler project recorded an accuracy rate of 90.39%, significantly higher than other companies' models (about 76%). Kakao Brain unveiled the Labeler project on GitHub and published a paper titled 'CheX-GPT: Harnessing Large Language Models for Enhanced Chest X-ray Report Labeling' on arXiv, an open-access archive. Meanwhile, Kakao Brain is striving to share AI technology know-how and create new value in line with Kakao and the community's core value of 'a better world created by technology.' The unveiling of the Labeler project is also aimed at promoting the AI open-source ecosystem, exemplified by the open-source project 'Honeybee' (tentative name) released in January. Kim Il-du, CEO of Kakao Brain, stated, "We plan to release a test set we created so that many researchers can use Kakao Brain's Labeler project as a benchmark for testing." He also added, "We plan to further improve the performance of the labeler project by utilizing our language model and incorporating additional chest X-ray data." Kakao Brain is a Korea-based global AI technology company. Founded in 2017, Kakao Brain aims to develop AI technology that will change people's lifestyle and embraces the challenge of asking the 'Unthinkable Question' to spark innovation, allowing everyone to live better lives. Kakao Brain has developed numerous innovative AI technologies and services designed to enhance people's quality of life through continuous technological innovation. These include the large-scale language model KoGPT and the image generation model Karlo. Additionally, Kakao Brain contributes to the development of the AI technology community by releasing 'Coyo,' a dataset consisting of approximately 740 million images and text. More information about Kakao Brain can be found on their official website: . SOURCE Kakao Brain

Final results from inspIRE study demonstrate 80% freedom from atrial arrhythmia recurrence at 12 months in patients with optimal Pulsed Field Ablation applications First look results from admIRE study suggests similar outcomes IRVINE, Calif., Feb. 2, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced 12-month results from the company-sponsored inspIRE study, "Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation (PFA) Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE," presented as a late-breaking presentation at the 29th Annual International AF Symposium.1 Interim results from the company-sponsored admIRE study, titled "PFA Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study," were also shared in a late-breaking presentation.2 Both the inspIRE and admIRE studies were conducted using the Biosense Webster VARIPULSE™ Platform, consisting of the VARIPULSE™ Catheter – a fully integrated variable-loop multielectrode catheter; the TRUPULSE™ Generator – a multichannel PFA generator; and the CARTO™ 3 System VARIPULSE™ Service Pack Software, which provides full integration with the world's leading 3D cardiac mapping system. The CARTO™ System enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms. "Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures," said Jasmina Brooks, President, Biosense Webster, Inc. "The encouraging outcomes from clinical trials with VARIPULSE™ fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation." Data from inspIRE Demonstrate 80% of Patients Achieved Freedom from Recurrence with Zero Primary Adverse Events The inspIRE study evaluated the safety and effectiveness of the VARIPULSE™ Platform for the treatment of drug-refractory paroxysmal AFib in Europe and Canada.1 In the study, the primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AFib, Atrial Tachycardia, or Atrial Flutter) was 75.6%. Among participants receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint.1 The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the VARIPULSE™ Platform to the CARTO™ 3 System. The safety results demonstrated a primary adverse event rate of 0.0%ii.1 "High efficacy of 80% freedom from atrial recurrence at 12 months and a strong safety profile are promising evidence of the capabilities of the VARIPULSE™ Platform," said Vivek Y. Reddy, M.D., Director of Electrophysiology at the Mount Sinai Fuster Heart Hospital and The Helmsley Trust Professor of Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, corresponding author for the inspIRE study publication.iii "As the VARIPULSE™ Platform was designed to integrate seamlessly with the CARTO™ 3 Mapping System, this technology should be able to effectively treat patients with atrial fibrillation with low radiation exposure to patients and lab staff alike." admIRE Pilot Results Show All Pilot Phase Patients Achieved Acute Success and 80% Remained Free from Atrial Arrhythmia Recurrence After One Year Twelve-month outcomes data from the pilot phase of the admIRE study, which assessed the safety and efficacy of the VARIPULSE™ Platform among U.S. patients, were presented as a late-breaker at the AF Symposium.2 Among 20 patients who completed the 12-month follow-up visit, 100% achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.2 No procedure or device-related primary adverse events were reported in the pilot phase of the study.2 For patients who had received ablation, median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively, as a result of the CARTO™ integration.2 "The results observed in the pilot phase of the admIRE study point to the promise of the VARIPULSE™ Platform in treating patients with paroxysmal AFib," said David Newton, M.D., Clinical Cardiac Electrophysiologist, Memorial Health University Medical Center, Savannah, Georgia.iv "These initial results are encouraging and demonstrate the potential for the VARIPULSE™ Platform to become a key component of the suite of tools electrophysiologists have at their disposal to perform catheter ablations." AFib is the most common type of cardiac arrhythmia and affects more than 6 million people in the United States and nearly 38 million people worldwide.3,4 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.5 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression.6 Catheter ablation is a safe and effective procedure when drugs don't work to help restore the heart's incorrect electrical signals, which cause an abnormal heart rhythm.7 About inspIRE The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by PFA System With Irreversible Electroporation [IRE]) (NCT04524364) was a prospective, multi-center, single-arm study of drug-refractory PAF, conducted at 13 institutions in Canada and Europe, from March 2021 to May 2022. In the study, PVI was performed with the VARIPULSE™ Platform. Follow up with 24-hour Holter monitoring was performed at three, six, and 12 months. Remote rhythm monitoring was performed weekly from three to five months; monthly, from six to 12 months; and for symptoms. The primary effectiveness endpoint (PEE) was acute PVI plus freedom from all atrial arrhythmia (AFib, Atrial Tachycardia, or Atrial Flutter), at 12 months. This final analysis of the study focused on the pivotal phase (Wave II) per-protocol population of 186 patients with 12 months of follow up. About admIRE The admIRE study (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Biosense Webster IRE Ablation System) (NCT05293639) is a prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the VARIPULSE™ Platform when used for isolation of pulmonary veins in treatment of patients in the United States with symptomatic drug refractory paroxysmal AFib. Pulmonary vein isolation (PVI) was achieved using the VARIPULSE™ Platform. The study consisted of a pilot phase, which assessed initial device safety and effectiveness, and a pivotal phase, which assessed these against pre-specified performance goals. The primary safety endpoint was incidence of early onset (within seven days) primary adverse events; atrio-esophageal fistula (within 90 days); cardiac tamponade or perforation (within 30 days); and PV stenosis (within 12 months). Acute procedure success (defined as confirmed entrance block at the end of procedure) and freedom from documented atrial arrhythmia recurrence at 12 months were also assessed. About the VARIPULSE™ Platform The VARIPULSE™ Platform is Biosense Webster's Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE™ Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. In the U.S., the VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory authorities. In Europe, the TRUPULSE™ generator received CE mark in late 2023 and VARIPULSE™ Catheter is pending CE mark. About Biosense Webster Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical-technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter. About Johnson & Johnson MedTechii At Johnson & Johnson MedTech,i we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE™ Platform clinical trials. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. None of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. US_BWI_THER_303927.1 i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's MedTech segment. ii Primary adverse events were defined as myocardial infarction, thromboembolism, transient ischemic attack, diaphragmatic paralysis, pneumothorax, heart block, pulmonary edema, vagal nerve injury, pericarditis, major vascular access complication or bleeding, death, stroke, or any other cerebrovascular accident. Atrioesophageal fistula and PV stenosis occurring >7 days post ablation along with cardiac tamponade or perforations occurring within 30 days of the ablation procedure were also considered primary adverse events. iii Nemocnice na Homolce entered into a clinical trial agreement with Johnson & Johnson Medical NV/SA for their participation in the inspIRE Study. Dr. Reddy served as a study coinvestigator. Dr. Reddy was compensated for consultancy purposes for his Multielectrode IRE Catheter Program Study Advisory Committee membership. Dr. Reddy was not compensated for this authorship contributions. iv Memorial HCA Savannah entered into a clinical trial agreement with Biosense Webster, Inc. for their participation in the admIRE Study. Dr. Newton served as a study coinvestigator. Dr. Newton serves as a consultant for BWI. Dr. Newton was not compensated for this authorship contributions. 1 Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston. 2 Newton D, Natale A, Mansour M, Nair D, Senn T. Pulsed Field Ablation Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study [abstract]. In: AF Symposium.; February 2-4; Boston. 3 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum in: Int J Stroke. 2020 Jan 28;1747493020905964. PMID: 31955707. 4 Kornej J, Börschel CS, Emelia J. Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. Circulation Research. 2020 June;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340 5 Staerk, et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ 2018;361:k1453 doi: 10.1136/bmj.k1453 6 Kuck KH, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace 2021;23(3)362-369. doi: 10.1093/europace/euaa298. 7 Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 2014;64(7),647–656. doi: 10.1016/j.jacc.2014.04.072 SOURCE Biosense Webster