
RetinAI and FVS Announce CE-MDR Certification for Co-developed AI-based Diabetic Retinopathy Screening Algorithm, LuxIA®
LuxIA is designed to screen adult diabetic patients for more-than-mild diabetic retinopathy (mtmDR). This indication for use provides critical support for ophthalmologists, general practitioners and trained healthcare professionals across the European Union to achieve an earlier diagnosis of mtmDR, a vision-threatening eye disease. This new certification demonstrates the strong collaboration between FVS and RetinAI, emphasizing both entities' commitment to deliver AI-driven tools that meet stringent regulatory standards and significantly enhance patient management and clinical outcomes.
The device is indicated for processing digital 45-degree colour fundus images from NW200, NW400 or equivalent Topcon cameras, ensuring seamless placement into existing clinical workflows. Together with RetinAI's existing portfolio of AI-based OCT analysis solutions, LuxIA complements a comprehensive suite of clinically validated, CE-certified AI modules focused on ophthalmology.
Dr. Carlos Ciller, CEO and co-founder of RetinAI, commented: 'Receiving CE-MDR certification for LuxIA underscores our shared commitment with FVS to advance leading-edge ophthalmic care to patients through reliable and impactful AI technology. This milestone is pivotal, enabling healthcare providers to improve patient management and outcomes for diabetic retinopathy across Europe, reinforcing our joint mission of transforming vision care through innovation.'
Dr. Juan Donate, MD, President of Fundación Ver Salud stated: 'We are excited about the newly received certification and look forward to the significant impact LuxIA will have in the European ophthalmology market. AI-driven screening solutions are critical to improving patient care, and we anticipate LuxIA will play a central role in achieving this.'
For further information or to request a demonstration of LuxIA and other ophthalmic solutions from FVS and RetinAI, please visit retinai.com.
For further information please contact:
At the company
Carlos Ciller, PhD, CEO - Ikerian AG and RetinAI Inc US [email protected], [email protected]
Media enquiries
Sue Charles, Charles Consultants - [email protected] +44 (0)7968726585
About Ikerian AG www.ikerian.com and RetinAI Inc. US www.retinai.com
Established in 2017, Ikerian AG (formerly RetinAI Medical AG) and its subsidiary, RetinAI U.S. Inc. ('Ikerian', 'RetinAI' and, together, 'the company'), develops software solutions to accelerate clinical, research and pharmaceutical workflows globally using advanced machine learning and computer vision, across ophthalmology, neurodegenerative disorders, vascular conditions, and rare diseases.
RetinAI builds tools to collect, organize and analyze health data from the eyes, enabling healthcare professionals to make the right decisions sooner in healthcare. RetinAI's international team leverages its clinical, technical, and scientific expertise to foster the transition from reactive to preventive medicine for severe eye diseases.
Follow us on LinkedInand
About FVS www.fundacionversalud.es/
FVS is a non-profit organization focused on training, research, and medical innovation, particularly in the field of ophthalmology. Its mission is to develop solutions that promote better clinical outcomes and enhance the quality of patient care.
Follow us on LinkedIn https://www.linkedin.com/in/fundaci%C3%B3n-ver-salud-983a621b3/ and X https://x.com/fversalud
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Business Wire
8 minutes ago
- Business Wire
Hyperfine Swoop® AI-Powered Portable MRI System Showcased in Clinical Studies Designed to Broaden Access to Dementia Care
GUILFORD, Conn.--(BUSINESS WIRE)-- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced two significant advancements highlighting the potential of its innovative MRI technology to expand dementia screening, enhance monitoring, and improve care. A new study conducted by the University of Kansas Alzheimer's Disease Research Center is exploring the use of the next-generation Swoop® system to expedite dementia diagnosis in a memory clinic. Globally, over 57 million people live with dementia, with Alzheimer's disease accounting for 60–80% of cases (Centers for Disease Control, World Health Organization). Limited access to conventional MRI, particularly in underserved and rural areas, often delays diagnosis and treatment. The Swoop® system addresses these barriers by delivering portable, accessible brain imaging in outpatient settings, including neurology clinics and infusion centers. A new study conducted by the University of Kansas Alzheimer's Disease Research Center is exploring the use of the next-generation Swoop® system to expedite dementia diagnosis in a memory clinic. Led by Dr. Jeffrey Burns, the Accelerated Clinical Evaluations for Alzheimer's Disease (ACE-AD) pioneers an innovative approach that combines in-office MR imaging, cognitive testing, and blood biomarkers into a single nurse-led clinic visit, aimed to improve patient care and ease healthcare system burdens. Dr. Burns highlights the importance of accessibility, stating, "The shortage of cognitive specialists limits our ability to meet growing demand for dementia care. Tools like the Swoop® system could enable scalable, timely diagnoses and earlier treatment, particularly for patients in rural and underserved areas." Additionally, two poster presentations from researchers in the Benzinger Lab at Washington University School of Medicine in St. Louis will be presented at this year's Alzheimer's Association International Conference, including interim results from the CARE PMR study, which evaluates the use of the Swoop® system for ARIA-E monitoring. Title: The Use of Portable MRI in the Detection and Monitoring of Amyloid-Related Imaging Abnormalities Authors: J. Hu, K. Sharifi, H. Alkelani, et al. Title: Assessing Low-field MRI Volumetric and White Matter Hyperintensity Lesion Measures using WMH-SynthSeg Authors: H. Shimony, S. Keefe, H. Alkelani, et al. 'These studies underscore how the Swoop® system is transforming brain imaging by bringing MRI to serve patients and clinicians across brain conditions where MRI access can significantly improve care,' said Maria Sainz, President and CEO of Hyperfine, Inc. 'Neurodegenerative conditions represent immense clinical and economic burdens for patients, caregivers, and health systems globally. The work that leading clinicians are doing with the Swoop® system in dementia screening and Alzheimer's drug therapy monitoring sets the stage for very large expansion opportunities for Hyperfine.' For more information about the Swoop® system, please visit Centers for Disease Control and Prevention. About Alzheimer's. Alzheimer's Disease & Dementia. Updated August 15, 2024. Accessed July 22, 2025. ‑dementia/about/ World Health Organization. Dementia. World Health Organization News‑Room Fact Sheets. Published March 31, 2025. Accessed July 22, 2025. About the Swoop® Portable MRI Systems The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. About Hyperfine, Inc. Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine, Inc. Forward-Looking Statements This press release includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the 'Company') may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,' 'should,' 'believes,' 'predicts,' 'potential,' 'continue,' and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company's goals and commercial plans, the benefits of the Company's products and services, and the Company's future performance and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company's product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the impact of COVID-19 on the Company's business; the inability to maintain the listing of the Company's Class A common stock on the Nasdaq; the Company's inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company's products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company's products and services and reimbursement for medical procedures conducted using the Company's products and services; the Company's estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company's financial performance; and other risks and uncertainties indicated from time to time in Company's filings with the Securities and Exchange Commission, including those under 'Risk Factors' therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.


Business Wire
8 minutes ago
- Business Wire
Aditxt's Subsidiary Pearsanta Receives an Invitation to Submit Full Proposal for the U.S. Department of Defense Pilot Award for the Development of its Mitomic® Ovarian Test
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aditxt, Inc. (NASDAQ: ADTX) ("Aditxt" or the "Company"), a social innovation platform accelerating promising health innovations, is pleased to announce that its subsidiary, Pearsanta, Inc. (' Pearsanta'), has received an invitation to submit a full proposal for the Congressionally Directed Medical Research Program's (CDMRP) Ovarian Cancer Research Program ('OCRP') Pilot Award, funded through the U.S. Department of Defense (Funding Opportunity Number: HT942525OCRPPA) for its Mitomic® Ovarian Test ('MOT™'), a novel blood-based diagnostic for ovarian cancer. Pearsanta's Mitomic® technology is a platform that is designed to use mitochondrial DNA to identify biomarkers and to develop tests for early detection of cancer and other diseases. Pearsanta is currently conducting clinical validation of the first two tests that have been developed based on this technology for early detection of prostate cancer and endometriosis. MOT™ will potentially be another blood-based test to be added to the Company's product pipeline designed for earlier detection of ovarian cancer. Ovarian cancer currently has a poor prognosis due to the fact that it is typically detected in later stages. Early detection of ovarian cancer can potentially improve the outcomes for women who face this terrible disease. Pearsanta submitted a pre-proposal on June 10, 2025, which was favorably reviewed for its scientific merit, level of innovation, alignment with OCRP Areas of Interest, and potential impact. The full proposal, titled 'Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Ovarian Cancer,' is currently under development and will be submitted by the September 11, 2025, deadline. The OCRP Pilot Award offers up to $350,000 over two years to support high-risk, high-reward research that could lead to critical discoveries and advance the field of ovarian cancer diagnostics and treatment. Pearsanta's proposed project aligns directly with the program's priority to 'identify and develop new strategies for screening, early-stage detection, accurate diagnosis, and prognosis.' 'Early detection is one of the greatest unmet needs in ovarian cancer care,' said Chris Mitton, President of Pearsanta. 'Our Mitomic® Ovarian Test has the potential to enable timely, more effective interventions, improve survival rates, and ultimately save lives. If successful, it could change the standard of care by offering a simple blood test that detects ovarian cancer at an earlier, more treatable stage—potentially improving survival and quality of life for women.' The study aims to further develop and validate the MOT™ at Pearsanta's Richmond, Virginia CLIA/CAP laboratory and monitoring facility in preparation for commercial launch as a laboratory-developed test (LDT). Plans include a prospective, multi-center clinical study to collect and analyze blood samples from women undergoing evaluation for suspected ovarian cancer. 'Pearsanta's continued progress is a powerful validation of our mission to accelerate promising health innovations with real-world impact,' said Amro Albanna, CEO of Aditxt. 'We believe the Mitomic® platform has the potential to transform how diseases are detected and managed. Supporting the development of the MOT™ reflects our broader strategy to Acquire high-potential innovations, Build them into clinically and commercially viable solutions, and Capitalize their value to drive scalable deployment globally. About Pearsanta Pearsanta is at the forefront of precision health, focusing on early cancer detection through advanced diagnostic technologies. Its proprietary Mitomic Technology Platform leverages the unique properties of mitochondrial DNA to detect cancer and other diseases with high accuracy via non-invasive, blood-based liquid, biopsy tests. Pearsanta's asset portfolio also includes a range of other innovative diagnostic technologies, all aimed at transforming early disease detection and monitoring, enabling more informed treatment decisions and ultimately improving patient outcomes. For more information, please visit About Aditxt, Inc. Aditxt, Inc. is a social innovation platform accelerating promising health innovations. Aditxt's ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to "Make Promising Innovations Possible Together." The innovation platform is the cornerstone of Aditxt's strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder's voice is heard and valued, and empowers collective progress. The Company currently operates two programs focused on immune health, and precision health. Through the proposed acquisition of Evofem under the July 2024 Amended and Restated Merger Agreement between Evofem, Aditxt and Adifem, Inc., as amended (the "A&R Merger Agreement"), Aditxt aims to introduce an additional program dedicated to women's health. The companies are working toward a targeted close in the second half of 2025. The closing of the transaction with Evofem is subject to several conditions, including but not limited to approval of the transaction by Evofem's shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Evofem, which includes approximately $15.0 million required to satisfy Evofem's senior secured noteholder; should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. No assurance can be provided that all of the conditions to closing will be obtained or satisfied, or that the transaction will ultimately close. Forward-Looking Statements This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, "achieving," "advancing", "aim," "are working to," "believe," "completing," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "seek," "should," "suggest," "strategy," "target," "will," "would," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to the potential success of Pearsanta's proposal for the U.S. Department of Defense Pilot Award; the ability of Pearsanta's Mitomic technology, including the MOT, to detect cancer or other diseases; Pearsanta's ability to commence in-human clinical trials on the proposed timeline, if at all; Aditxt's ability to successfully execute its mission to accelerate and monetize promising health innovations, and magnitude thereof; Aditxt's ability to complete the proposed initial public offering of Pearsanta on the proposed timeline, if at all; and Aditxt's ability to close the planned acquisition of Evofem, including to meet all closing conditions, and the timing thereof. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in each company's SEC filings, including Aditxt's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025, and any subsequent Form 10-Q filings. All forward-looking statements are expressly qualified in their entirety by such factors. Aditxt undertakes no duty to update any forward-looking statement except as required by law. For more information, please visit Follow Aditxt on:


Business Wire
8 minutes ago
- Business Wire
Apiture Launches Real-Time Payments for Community Banks and Credit Unions
WILMINGTON, N.C.--(BUSINESS WIRE)-- Apiture, a leading provider of digital banking solutions, today announced the availability of real-time payment capabilities for its community bank and credit union clients. With this enhancement, Apiture clients can enable their consumer and business account holders to send and receive payments instantly, 24/7/365, through The Clearing House's RTP ® network and the Federal Reserve's FedNow ® Service. As demand for faster, more reliable payment experiences continues to grow, real-time payments adoption is steadily increasing, especially among businesses. Over half of American companies were already using RTP and FedNow in 2024, according to a study from U.S. Bank, with adoption projected to reach 80% by 2026. As real-time payments shift from a competitive advantage to a customer expectation, offering this capability is becoming increasingly important for community banks and credit unions to compete with larger financial institutions. The Apiture Digital Banking Platform provides a comprehensive suite of payment options enabling consumers and businesses to choose the best payment method based on their specific use case. The new real-time payments capability builds upon Apiture's existing faster payment options, including domestic and international wire transfers with real-time foreign exchange rates. Additional payment services available to Apiture clients include bill pay, peer-to-peer payments, internal and external transfers, and ACH transactions. 'Whether to support company payroll, bill payments, gig worker payments, early wage access, government disbursements, or P2P transfers, real-time payments have emerged as a highly effective way for consumers and businesses to instantly send and receive account-to-account payments,' said Chris Cox, chief operating officer at Apiture. 'This represents another step in our ongoing mission to help community and regional financial institutions deliver the features today's consumers and businesses need and expect.' For more information, visit About Apiture Apiture delivers award-winning digital banking solutions to banks and credit unions throughout the U.S. Our flexible, highly configurable solutions meet a wide range of financial institutions' needs, from leveling the playing field with larger institutions to supporting growth through innovative data intelligence and embedded banking strategies. With our API-first approach, our clients can maximize the capabilities of their platform while preserving a seamless user experience. Our exclusive focus on digital banking, and a team with hundreds of years of collective experience working at U.S. financial institutions, means we are dedicated to meeting the unique needs of our clients while providing a level of support that is unmatched in the industry. Apiture is headquartered in Wilmington, North Carolina. To learn more, visit