Latest news with #NotalVision
Associated Press
09-07-2025
- Health
- Associated Press
Pivotal Data Validates Diagnostic Equivalence of SCANLY Home OCT and In-Office OCT in Wet AMD Management
Manassas, Virginia--(Newsfile Corp. - July 9, 2025) - Notal Vision, a digital healthcare provider advancing remote patient monitoring in ophthalmology, announced the publication of pivotal study data in Ophthalmology Science validating the clinical performance and patient usability of the SCANLY Home OCT in the management of neovascular age-related macular degeneration (AMD).¹ The results contributed to the FDA's first-ever clearance of an AI-powered home OCT device for use in ophthalmology. Until now, the ability of wet AMD patients to self-image on a compact, home-based OCT device had only been demonstrated in smaller longitudinal at-home 2,3 and cross-sectional in-office studies. 4 This pivotal longitudinal study expanded on those findings and demonstrated strong agreement between SCANLY-acquired images and standard in-office OCT in identifying hypo-reflective spaces (HRS), an important biomarker in wet AMD that typically indicates fluid. Conducted across seven U.S. retina practices representing a mix of urban and rural populations, the longitudinal trial enrolled 180 patients from a broader 500-subject study program, including those with concurrent ocular conditions to reflect real-world pathology. Participants received SCANLY devices via courier from the Notal Vision Monitoring Center. They did not receive any training on how to use the device but had the option to call the Monitoring Center for support if needed. Patients were instructed to self-image daily over a five-week period. To assess image agreement, patients also underwent 2-3 in-office visits for comparative OCT scans. All images were independently graded by masked graders for the presence of HRS. SCANLY met its prespecified endpoint of ≥80% agreement, achieving a positive percent agreement (PPA) of 86.6% and a negative percent agreement (NPA) of 86.1%. Discrepancies were primarily attributed to grader errors or trace amounts of HRS. The study also confirmed high patient usability: 96.1% of eligible participants successfully initiated at-home imaging, averaging 5.9 scans per eye per week. Phone support was minimally required, with patients averaging just 0.21 support calls per month. [ This image cannot be displayed. Please visit the source: ] Figure: Side-by-side comparison of SCANLY and in-office OCT demonstrating high concordance in detecting hypo-reflective spaces in wet AMD patients. To view an enhanced version of this graphic, please visit: 'Home-based OCT monitoring represents a fundamental shift in personalized retina care,' said Jeffrey S. Heier, MD, Director of the Retina Service at Ophthalmic Consultants of Boston. 'The SCANLY pivotal data and subsequent FDA clearance represents a significant advance in remote diagnostics for chronic retinal disease.' 'We're proud to share these robust findings,' added Kester Nahen, PhD, CEO of Notal Vision. 'They validate that patients with wet AMD can reliably self-image at home, supporting treating retina specialists in their clinical decision-making between office visits.' The SCANLY Home OCT Monitoring Program, provided by the Notal Vision Monitoring Center, enables prescribing retina specialists to leverage AI-enabled alerts and real-time imaging data to individualize care while maintaining clinical oversight. References: 1. Heier, Jeffrey S., et al. Pivotal Trial Validating Usability and Visualization Performance of Home OCT in Neovascular Age-Related Macular Degeneration: Report 1. Ophthalmol Sci. 2025 Mar 21;5(5):100772. doi: 10.1016/ 2. Blinder, Kevin J., et al. Home OCT Imaging for Newly Diagnosed Neovascular Age-Related Macular Degeneration: A Feasibility Study. Ophthalmol Retina. 2023 Oct 23:S2468-6530(23)00514-6. doi: 10.1016/ 3. Liu, Yingna, Nancy M. Holekamp, and Jeffrey S. Heier. Prospective, longitudinal study: daily self-imaging with home OCT for neovascular age-related macular degeneration. Ophthalmology Retina. 2022 Jul;6(7):575-585. doi: 10.1016/ 4. Kim, Judy E., et al. Evaluation of a self-imaging SD-OCT system designed for remote home monitoring. BMC Ophthalmol. 22, 261 (2022). doi: 10.1186/s12886-022-02458-z ### About Notal Vision Notal Vision is a patient-centric ophthalmic remote monitoring services provider extending care from the clinic to the home. We empower physicians with innovative home-based technologies and remote monitoring services that support patient management between office visits. Our solutions combine self-operated digital diagnostic devices, AI-enabled data analysis, and a physician-led monitoring center-all with the goal of helping preserve patients' vision. Learn more at The Medicare-accredited and ophthalmologist-led Notal Vision Monitoring Center is dedicated to remote monitoring and patient engagement. Staffed by certified ophthalmic professionals, the center provides nationwide service for age-related macular degeneration (AMD) monitoring. Notal Vision offers two distinct remote monitoring solutions: Together, these programs support physicians across the full spectrum of AMD care-from early detection to ongoing disease management. Media Contact: Candice Morin [email protected] To view the source version of this press release, please visit
Associated Press
24-06-2025
- Business
- Associated Press
Hadley and Notal Vision Partner to Empower Patients with Vision Loss Through Education and Leading Technology
Partnership will introduce Hadley services to Notal Vision patients Winnetka, Illinois--(Newsfile Corp. - June 24, 2025) - Hadley, a leading nonprofit empowering people with vision loss to adapt and thrive, and Notal Vision, a pioneer in AI-driven home diagnostic tools and digital healthcare for retinal diseases, today announced a strategic partnership to bridge the gap between early detection, treatment monitoring, and adaptive living for patients with age-related macular degeneration (AMD). The collaboration will connect users of Notal Vision's ForeseeHome and SCANLY Home OCT monitoring programs with Hadley's specialized programming, including Living with Macular Degeneration workshop series ( ). Notal Vision will connect patients experiencing vision loss to Hadley's free online practical and social/emotional content and programming. A co-produced podcast will feature experts discussing early detection of eye diseases and the role of at-home monitoring. Specifically, the partnership will highlight the combined benefits of Notal Vision's ForeseeHome and SCANLY Home OCT together with Hadley's free support. Coordinated email campaigns and social media efforts will highlight the synergy between home monitoring and social/emotional programming and amplify resources for patients, family members, and caregivers. 'Hadley is thrilled to partner with Notal Vision to reach more individuals facing vision loss,' said Johnjoe Farragher, President & CEO of Hadley. 'Our Living with Macular Degeneration workshop, one of many social/emotional programs, provides Notal Vision patients with actionable tools to mitigate functional decline, complementing the critical role of ForeseeHome and SCANLY Home OCT in disease monitoring.' 'AMD management requires both technological and behavioral interventions,' noted Dr. Kester Nahen, CEO of Notal Vision. 'By referring our patients to Hadley's programs in our patient outreach, we empower individuals to proactively address vision changes - reducing anxiety and improving adherence to clinical follow-ups.' About the Social / Emotional Programs & Technology Hadley's Living with Macular Degeneration : A workshop series covering assistive technology, home safety, and coping strategies, grounded in research on low-vision rehabilitation. : A workshop series covering assistive technology, home safety, and coping strategies, grounded in research on low-vision rehabilitation. Notal Vision's ForeseeHome: An FDA-cleared medical device that uses AI to analyze at-home visual field data, helping clinicians detect wet AMD progression early with 81% of patients having functional vision of 20/40 or better at diagnosis (per Ho AC. et al., J. Clin. Med., 2021). Notal Vision's SCANLY Home OCT: An FDA-cleared AI-powered medical device that allows physicians to track disease activity and treatment response in patients with wet AMD (per Holekamp NM et al., Retina 2024). About Hadley Hadley provides both practical help and social/emotional support to older adults adjusting to vision loss, empowering them to adapt and thrive. Founded in 1920, Hadley currently serves more than 150,000 individuals across the country and around the world. Visit for more. Contact Information: Burke Patten, Marketing Director, [email protected] , 847-784-2869. About Notal Vision Notal Vision is a patient-centric digital healthcare provider extending retinal care from the clinic to the home. We empower physicians with innovative home-based technologies and home monitoring services that support patient management between office visits. Our solutions combine self-operated digital diagnostic devices, AI-enabled data analysis, and a physician-led monitoring center-all with the goal of helping preserve patients' vision. Learn more at . Contact Information: Candice Morin, Communications Director, [email protected] , 401-284-6378 To view the source version of this press release, please visit
Associated Press
22-04-2025
- Health
- Associated Press
Home OCT Impacts Physician Decision Making
Retrospective Case Review Study Utilized AI-enriched Data Manassas, Virginia--(Newsfile Corp. - April 22, 2025) - Digital healthcare provider, Notal Vision, announced that the results of a new study evaluating the impact of home OCT data on disease management decisions for neovascular age-related macular degeneration (nAMD) patients were published in the Journal of VitreoRetinal Diseases. While several studies have shown feasibility of home OCT monitoring with nAMD patients acquiring near daily scans, this is the first-ever study to demonstrate changes in physician decision making due to availability of home OCT data. Fifteen board-certified retina specialists, with diverse practice experiences, were asked to make management decisions after reviewing home OCT data previously collected from patients managed under standard of care treatment by different physicians. The reviewers had access to home OCT volume scans as well as AI-based analytics of hypo-reflective spaces shown on B-scans, en-face projection maps, and longitudinal volume trajectories via a web-based portal. The study demonstrated the strong impact of home OCT data review on physician decision making. In nearly every case in this simulated environment, physicians made a different decision regarding choice and timing of treatment. In over 42% of cases, physicians decided they would not treat the patient when they were treated in real life. In the remaining cases, when physicians did decide to treat, they would have brought the patients in earlier by one or more weeks in 61% of instances. The study demonstrated that the utilization of home OCT can lead to significant optimization of patient care. The authors concluded a savings potential of over $1 billion to the healthcare system by avoiding early treatments. [ This image cannot be displayed. Please visit the source: ] The illustration describes data presented to physicians related to Home OCT. Information about the past treatment was provided. The physicians had to make the decision on if and when to plan patient's treatment based on home OCT. The information related to the actual treatment during the shown period was masked. To view an enhanced version of this graphic, please visit: 'Given the AI-enriched insights in disease activity and treatment response home OCT provides, we all expected it to impact our management, but we were certainly surprised by the level of change in treatment decisions observed in this study,' said Ankoor R. Shah, MD, Retina Consultants of Texas, and the senior author of the study. 'There is no doubt that review of highly granular, up-to daily OCT data is meaningful and critical to improve personalized care, preventing both over and under treatment.' The projected socio-economic impact of home OCT monitoring was analyzed based on physician decisions made in this study. The first findings were presented by Miguel Busquets, MD of Retina Associates of Kentucky and EyeCare Partners, at the American Society of Retina Specialists annual meeting in Stockholm last year. Further study results were presented by Aleksandra Rachitskaya, MD of Cole Eye Institute at the 2024 EURETINA annual meeting in Barcelona, Spain, and by Paul Hahn, MD of New Jersey Retina and Prism Vision Group at the 2024 American Academy of Ophthalmology annual meeting in Chicago. Disclaimer: Although the studies are scientifically sound and clinically relevant, they present some limitations, including that it was retrospective in nature and not designed to detect differences in visual outcomes or treatment-related costs. The current study was biased towards earlier treatment compared to actual care because it was not possible for the data reviewing physician to delay care beyond the date of actual treatment. Physician decisions were made based on anatomical data obtained from home OCT alone and visual acuity changes over time were not provided. The relatively small number of physicians, patients and eyes in this study limits the generalizability of the findings to all nAMD patients in the United States. We encourage physicians to read these studies to understand the strengths and limitations of the data. Please note that the FDA has not reviewed these studies. For some claims, Notal Vision may seek to broaden the indications with the FDA in the future using data, such as these studies, to provide the required substantiation. See product labeling [ for the indications for use and important safety information. ### About Notal Vision Notal Vision is a patient-centric ophthalmic remote monitoring services provider extending retinal disease monitoring from the clinic to the home, providing physicians with remote monitoring services to support their patient care between office visits. With a proven approach to home-based, self-operated diagnostics, AI-enabled data analysis, and patient engagement, our goal is to help doctors preserve patients' vision. The Notal Vision Monitoring Center (NVMC) is a remote, Medicare credentialed ophthalmic monitoring center and the epicenter of patient engagement. Led by practicing ophthalmologists and supported by certified ophthalmic professionals, the Monitoring Center offers a nationwide age-related macular degeneration (AMD) home monitoring service for patients. The ForeseeHome® AMD Monitoring Program is a comprehensive program, which includes an FDA-cleared device that monitors visual changes in intermediate dry AMD patients at risk of vision loss from undiagnosed wet AMD. With the addition of the SCANLY Home OCT system to the Notal Vision family of monitoring products, wet AMD patients are able to perform technician-free OCT scanning at home with rapid and self-guided fixation - critical components, especially for elderly patients frequently with pre-existing vision loss. The Notal Vision Monitoring Center provides patient data to the physician via the online SCANLY Portal. Physicians are provided 24/7 access to all their patients' B-scan images from each SCANLY Home OCT scan with the location of the hypo-reflective spaces annotated on each B-scan. The Notal OCT Analyzer (NOA), a proprietary machine learning algorithm, performs automated analysis of the Home OCT scans and generates a report to the physician when a physician specified change is detected. Following physician receipt of a change notification, a patient may be brought to the office for further evaluation if warranted. Media Contact: Candice Morin [email protected] To view the source version of this press release, please visit
Yahoo
22-04-2025
- Health
- Yahoo
Home OCT Impacts Physician Decision Making
Retrospective Case Review Study Utilized AI-enriched Data Manassas, Virginia--(Newsfile Corp. - April 22, 2025) - Digital healthcare provider, Notal Vision, announced that the results of a new study evaluating the impact of home OCT data on disease management decisions for neovascular age-related macular degeneration (nAMD) patients were published in the Journal of VitreoRetinal Diseases. While several studies have shown feasibility of home OCT monitoring with nAMD patients acquiring near daily scans, this is the first-ever study to demonstrate changes in physician decision making due to availability of home OCT data. Fifteen board-certified retina specialists, with diverse practice experiences, were asked to make management decisions after reviewing home OCT data previously collected from patients managed under standard of care treatment by different physicians. The reviewers had access to home OCT volume scans as well as AI-based analytics of hypo-reflective spaces shown on B-scans, en-face projection maps, and longitudinal volume trajectories via a web-based portal. The study demonstrated the strong impact of home OCT data review on physician decision making. In nearly every case in this simulated environment, physicians made a different decision regarding choice and timing of treatment. In over 42% of cases, physicians decided they would not treat the patient when they were treated in real life. In the remaining cases, when physicians did decide to treat, they would have brought the patients in earlier by one or more weeks in 61% of instances. The study demonstrated that the utilization of home OCT can lead to significant optimization of patient care. The authors concluded a savings potential of over $1 billion to the healthcare system by avoiding early treatments. The illustration describes data presented to physicians related to Home OCT. Information about the past treatment was provided. The physicians had to make the decision on if and when to plan patient's treatment based on home OCT. The information related to the actual treatment during the shown period was view an enhanced version of this graphic, please visit: "Given the AI-enriched insights in disease activity and treatment response home OCT provides, we all expected it to impact our management, but we were certainly surprised by the level of change in treatment decisions observed in this study," said Ankoor R. Shah, MD, Retina Consultants of Texas, and the senior author of the study. "There is no doubt that review of highly granular, up-to daily OCT data is meaningful and critical to improve personalized care, preventing both over and under treatment." The projected socio-economic impact of home OCT monitoring was analyzed based on physician decisions made in this study. The first findings were presented by Miguel Busquets, MD of Retina Associates of Kentucky and EyeCare Partners, at the American Society of Retina Specialists annual meeting in Stockholm last year. Further study results were presented by Aleksandra Rachitskaya, MD of Cole Eye Institute at the 2024 EURETINA annual meeting in Barcelona, Spain, and by Paul Hahn, MD of New Jersey Retina and Prism Vision Group at the 2024 American Academy of Ophthalmology annual meeting in Chicago. Disclaimer: Although the studies are scientifically sound and clinically relevant, they present some limitations, including that it was retrospective in nature and not designed to detect differences in visual outcomes or treatment-related costs. The current study was biased towards earlier treatment compared to actual care because it was not possible for the data reviewing physician to delay care beyond the date of actual treatment. Physician decisions were made based on anatomical data obtained from home OCT alone and visual acuity changes over time were not provided. The relatively small number of physicians, patients and eyes in this study limits the generalizability of the findings to all nAMD patients in the United States. We encourage physicians to read these studies to understand the strengths and limitations of the data. Please note that the FDA has not reviewed these studies. For some claims, Notal Vision may seek to broaden the indications with the FDA in the future using data, such as these studies, to provide the required substantiation. See product labeling [ for the indications for use and important safety information. ### About Notal Vision Notal Vision is a patient-centric ophthalmic remote monitoring services provider extending retinal disease monitoring from the clinic to the home, providing physicians with remote monitoring services to support their patient care between office visits. With a proven approach to home-based, self-operated diagnostics, AI-enabled data analysis, and patient engagement, our goal is to help doctors preserve patients' vision. The Notal Vision Monitoring Center (NVMC) is a remote, Medicare credentialed ophthalmic monitoring center and the epicenter of patient engagement. Led by practicing ophthalmologists and supported by certified ophthalmic professionals, the Monitoring Center offers a nationwide age-related macular degeneration (AMD) home monitoring service for patients. The ForeseeHome® AMD Monitoring Program is a comprehensive program, which includes an FDA-cleared device that monitors visual changes in intermediate dry AMD patients at risk of vision loss from undiagnosed wet AMD. With the addition of the SCANLY Home OCT system to the Notal Vision family of monitoring products, wet AMD patients are able to perform technician-free OCT scanning at home with rapid and self-guided fixation - critical components, especially for elderly patients frequently with pre-existing vision loss. The Notal Vision Monitoring Center provides patient data to the physician via the online SCANLY Portal. Physicians are provided 24/7 access to all their patients' B-scan images from each SCANLY Home OCT scan with the location of the hypo-reflective spaces annotated on each B-scan. The Notal OCT Analyzer (NOA), a proprietary machine learning algorithm, performs automated analysis of the Home OCT scans and generates a report to the physician when a physician specified change is detected. Following physician receipt of a change notification, a patient may be brought to the office for further evaluation if warranted. Media Contact:Candice Morincandicem@ To view the source version of this press release, please visit
