{"id":36124,"date":"2026-09-10T17:15:53","date_gmt":"2026-09-10T11:45:53","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=36124"},"modified":"2026-09-10T17:15:56","modified_gmt":"2026-09-10T11:45:56","slug":"medtech-news-for-emboline-alcon-avo","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-emboline-alcon-avo","title":{"rendered":"Emboline Secures FDA 510(k) Clearance for Emboliner\u00ae Embolic Protection System; Alcon\u2019s Clareon Monofocal IOL Secures EU MDR Certification from T\u00dcV S\u00dcD; Shoulder Innovations Enters Exclusive Partnership with ALM Ortho for Complex Shoulder Reconstruction Solutions; Avo Expands MEDITECH Alliance, Bringing Full Suite of AI Solutions to EHR; Nicklaus Children\u2019s Hospital Performs Pioneering Transcatheter Fontan Completion in Two-Year-Old Child; AEYE Health Publishes AEYE-DS Clinical Trial Results Demonstrating High Diagnostic Accuracy and >99% Imageability"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6aa2b1d195e18\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6aa2b1d195e18\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-emboline-alcon-avo\/#Emboline_Received_US_FDA_510k_Clearance_for_Emboliner%C2%AE_Embolic_Protection_System\" >Emboline Received U.S. FDA 510(k) Clearance for Emboliner\u00ae Embolic Protection System&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-emboline-alcon-avo\/#Alcons_Clareon_Monofocal_IOL_Received_EUMDR_Certification_Through_TUV_SUD\" >Alcon&#8217;s Clareon Monofocal IOL Received EUMDR Certification Through T\u00dcV S\u00dcD<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-emboline-alcon-avo\/#Shoulder_Innovations_Announced_Exclusive_Partnership_with_ALM_Ortho_to_Introduce_Bespoke_Solution_for_Complex_Shoulder_Reconstruction_Procedures\" >Shoulder Innovations Announced Exclusive Partnership with ALM Ortho to Introduce Bespoke Solution for Complex Shoulder Reconstruction Procedures&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-emboline-alcon-avo\/#Avo_Expands_MEDITECH_Alliance_Partnership_Bringing_Its_Suite_of_AI-Powered_Products_to_MEDITECHs_EHR\" >Avo Expands MEDITECH Alliance Partnership, Bringing Its Suite of AI-Powered Products to MEDITECH&#8217;s EHR&nbsp;&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-emboline-alcon-avo\/#Nicklaus_Childrens_Hospital_Performed_One_of_the_First_Transcatheter_Fontan_Completions_in_the_Country_on_a_Two-Year-Old_Child\" >Nicklaus Children&#8217;s Hospital Performed One of the First Transcatheter Fontan Completions in the Country on a Two-Year-Old Child&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-emboline-alcon-avo\/#AEYE-DS_Clinical_Trials_Published_First_Fully_Autonomous_Diabetic_Retinopathy_Screening_Technology_Across_Portable_and_Tabletop_Devices_Demonstrates_99_Imageability_One-Image-per-Eye_Workflow_and_Best-in-Class_Diagnostic_Efficacy\" >AEYE-DS Clinical Trials Published: First Fully Autonomous Diabetic Retinopathy Screening Technology Across Portable and Tabletop Devices Demonstrates 99% Imageability, One-Image-per-Eye Workflow, and Best-in-Class Diagnostic Efficacy&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-emboline-received-u-s-fda-510-k-clearance-for-emboliner-embolic-protection-system-nbsp\"><span class=\"ez-toc-section\" id=\"Emboline_Received_US_FDA_510k_Clearance_for_Emboliner%C2%AE_Embolic_Protection_System\"><\/span><strong>Emboline Received U.S. FDA 510(k) Clearance for Emboliner\u00ae Embolic Protection System&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 09 September 2026, Emboline announced that it had received U.S. FDA 510(k) clearance for its Emboliner Embolic Protection System, supporting the company&#8217;s advancement in the embolic protection device market. The system was developed to capture and remove embolic debris generated during transcatheter heart procedures, particularly transcatheter aortic valve replacement procedures.<\/p>\n\n\n\n<p>The Emboliner incorporated a dual-layer Nitinol mesh filter and an integrated access port that allowed procedural devices to pass through the filter while maintaining embolic protection. Its design provided coverage of all three cerebral vessels and was intended to capture debris that could potentially travel to the brain, kidneys, and other organs.<\/p>\n\n\n\n<p>The regulatory clearance followed positive clinical development of the technology. Emboline had previously completed enrollment in its 500-patient PROTECT Head-to-Head IDE trial, which compared Emboliner with Boston Scientific&#8217;s Sentinel Cerebral Protection System during TAVR. Results presented in 2026 showed that Emboliner was non-inferior to Sentinel for the evaluated safety and efficacy endpoints and demonstrated superior debris capture.<\/p>\n\n\n\n<p>The FDA clearance strengthened Emboline&#8217;s position in the embolic protection segment and supported the broader adoption of embolic protection technologies in structural heart procedures. The development also highlighted increasing efforts to reduce stroke and other ischemic complications associated with embolic debris released during TAVR and other transcatheter cardiac interventions.<\/p>\n\n\n\n<p><em>&#8220;The liberation of embolic debris is a universal concern during TAVR, but until now our ability to provide comprehensive protection of both the cerebral and systemic circulation has been limited,&#8221; said Tamim Nazif, MD, Co-Director of the Structural Heart and Valve Center at Columbia University Irving Medical Center and Co-Principal Investigator of the PROTECT H2H study. &#8220;The Emboliner represents an important step forward, providing full brain and body protection, while integrating seamlessly into the TAVR procedure. Having this new capability may give physicians greater confidence when treating patients in whom embolic risk is an important consideration, and I look forward to incorporating this technology into our clinical practice.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/embolic-protection-devices-market\">Embolic Protection Devices Market Report<\/a>,\u201d the global embolic protection devices market size is expected to increase from <strong>USD 648.51 million<\/strong> in 2024 to <strong>USD 1,161.31 million<\/strong> by 2032, reflecting strong and sustained growth. The global embolic protection devices market is growing at a <strong>CAGR of 7.58%<\/strong> during the forecast period from 2025 to 2032. The market for embolic protection devices is being primarily driven by the rising cases of cardiovascular disorders and neurovascular disorders, growing awareness of the cardiovascular and stroke risks associated with medical procedures, and an increase in technological advancements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-alcon-s-clareon-monofocal-iol-received-eumdr-certification-through-tuv-sud\"><span class=\"ez-toc-section\" id=\"Alcons_Clareon_Monofocal_IOL_Received_EUMDR_Certification_Through_TUV_SUD\"><\/span><strong>Alcon&#8217;s Clareon Monofocal IOL Received EUMDR Certification Through T\u00dcV S\u00dcD<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 01 September 2026, Alcon announced that its Clareon Monofocal intraocular lens had received EU MDR certification through T\u00dcV S\u00dcD. The certification confirmed that the lens met the applicable requirements under the European Union Medical Device Regulation.<\/p>\n\n\n\n<p>The certification supported the continued commercialization of the Clareon Monofocal IOL across European markets and strengthened Alcon\u2019s position in the cataract surgery and intraocular lens segment. The lens had been designed to provide predictable refractive outcomes and clear distance vision, while its portfolio also included a toric version for patients with astigmatism.<\/p>\n\n\n\n<p>The regulatory milestone contributed to the expansion of compliant and advanced intraocular lens options for cataract procedures in Europe and supported the broader growth of the global IOL market.<\/p>\n\n\n\n<p><em>&#8220;For nearly 80 years, Alcon has advanced cataract surgery through continuous innovation,&#8221; said Amar Vyas, Country Head India at Alcon. &#8220;Choosing the right IOL is about more than vision correction; it&#8217;s about aligning with each patient&#8217;s lifestyle and surgical objectives. Clareon Monofocal IOLs deliver exceptional optical clarity and consistent performance, enabling surgeons to achieve reliable distance and enhanced intermediate visual outcomes for their monofocal patients.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/intraocular-lens-market\"><strong>Intraocular Lens Market<\/strong><\/a>,\u201d the global intraocular lens market was valued at <strong>USD 4,648.96 million<\/strong> in 2024, growing at a <strong>CAGR of 6.12%<\/strong> during the forecast period from 2025 to 2032 to reach <strong>USD 7,414.66 million<\/strong> by 2032. The intraocular lens market is being significantly boosted by the growing cases of eye-related disorders such as cataracts, presbyopia, and astigmatism, which are increasing the demand for corrective surgical interventions. This rising disease burden is complemented by improved awareness and accessibility to eye care services, especially in developing regions, enabling more patients to seek treatment. Additionally, ongoing technological advancements in lens materials and designs such as the development of multifocal, toric, and extended depth-of-focus lenses are enhancing visual outcomes and patient satisfaction. Furthermore, increased product development activities by key market players are leading to the introduction of innovative and customized IOL solutions, collectively accelerating the growth of the global intraocular lens market during the forecast period from 2025 to 2032.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-shoulder-innovations-announced-exclusive-partnership-with-alm-ortho-to-introduce-bespoke-solution-for-complex-shoulder-reconstruction-procedures-nbsp\"><span class=\"ez-toc-section\" id=\"Shoulder_Innovations_Announced_Exclusive_Partnership_with_ALM_Ortho_to_Introduce_Bespoke_Solution_for_Complex_Shoulder_Reconstruction_Procedures\"><\/span><strong>Shoulder Innovations Announced Exclusive Partnership with ALM Ortho to Introduce Bespoke Solution for Complex Shoulder Reconstruction Procedures&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 09 September 2026, Shoulder Innovations announced an exclusive collaboration with ALM Ortho to introduce patient-specific orthopedic implants for complex shoulder reconstruction procedures in the United States. The partnership focused on addressing severe shoulder deformities and complex revision cases where conventional implants may not provide an optimal solution. Under the collaboration, ALM Ortho planned to use patient imaging data to develop customized titanium implants tailored to individual patient anatomy and clinical requirements. Shoulder Innovations granted ALM Ortho exclusive rights to provide solutions for highly complex shoulder procedures. Shoulder Innovations was expected to leverage its surgeon network and commercial infrastructure to identify appropriate cases and connect surgeons and healthcare facilities with customized implant solutions.<\/p>\n\n\n\n<p>ALM Ortho was responsible for designing, manufacturing, and delivering the patient-specific implants to surgical teams. The collaboration expanded Shoulder Innovations\u2019 portfolio of shoulder reconstruction solutions and strengthened its position in complex shoulder and revision procedures. The partnership also underscored the increasing adoption of advanced additive manufacturing and patient-specific implant technologies in orthopedic surgery, particularly for challenging reconstruction procedures where standard implant options may be insufficient.<\/p>\n\n\n\n<p><em>&#8220;This collaboration bolsters our broader array of offerings to the shoulder surgical care market and importantly helps address a real unmet need for patients and surgeons facing these complex cases,&#8221; said Rob Ball, CEO of Shoulder Innovations. &#8220;We look forward to working with ALM Ortho with this new capability in the marketplace, which we expect will drive improved patient outcomes and yield strategic advantages for SI as our commercial engine continues to grow.&#8221;&nbsp;&nbsp;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/shoulder-replacement-devices-market\"><strong>Shoulder Replacement Devices Market Report<\/strong><\/a>,\u201d the shoulder replacement devices market was valued at <strong>USD 1.68 billion<\/strong> in 2023, growing at a <strong>CAGR of 7.27%<\/strong> during the forecast period from 2024 to 2030, to reach <strong>USD 2.54 billion<\/strong> by 2030. The shoulder replacement devices market is experiencing significant growth owing to the widespread instances of shoulder injuries and degenerative conditions like osteoarthritis and rheumatoid arthritis, the rise in product development &amp; innovation activities, among others that are acting as key factors, contributing to the market growth of the shoulder replacement devices market during the forecast period from 2024 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-avo-expands-meditech-alliance-partnership-bringing-its-suite-of-ai-powered-products-to-meditech-s-ehr-nbsp-nbsp\"><span class=\"ez-toc-section\" id=\"Avo_Expands_MEDITECH_Alliance_Partnership_Bringing_Its_Suite_of_AI-Powered_Products_to_MEDITECHs_EHR\"><\/span><strong>Avo Expands MEDITECH Alliance Partnership, Bringing Its Suite of AI-Powered Products to MEDITECH&#8217;s EHR&nbsp;&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 09 September 2026, Avo announced the expansion of its partnership with MEDITECH, enabling MEDITECH health systems to access Avo&#8217;s broader suite of artificial intelligence-powered clinical solutions through the MEDITECH Alliance. The expanded collaboration added Chart Assist and Ask Avo to the existing AI Scribe offering within the MEDITECH Expanse electronic health record platform.<\/p>\n\n\n\n<p>Through the expanded partnership, healthcare organizations gained access to three AI-based solutions designed to support clinical workflows. Chart Assist was developed to analyze patient charts, identify care gaps, assess discharge readiness, and automate documentation across inpatient, emergency, and outpatient settings. Ask Avo combined patient information with clinical evidence to support clinical questions, decision-making, and documentation, while AI Scribe converted clinician-patient conversations into structured clinical notes. Avo reported that its solutions had already been used by more than 35 MEDITECH customers. The company also reported operational and financial benefits across healthcare organizations, including reduced documentation time, higher reimbursement, increased outpatient encounters, and improved financial outcomes.<\/p>\n\n\n\n<p>The expanded integration strengthened the adoption of AI-enabled clinical technologies within electronic health record environments and highlighted the growing use of artificial intelligence to reduce administrative workloads, improve clinical decision-making, and enhance healthcare workflow efficiency.<\/p>\n\n\n\n<p><em>&#8220;Healthcare AI should do more than generate a better note. It should support clinicians at the point of care, while a decision can still change,&#8221; said Joongheum Park, MD, Chief Product &amp; AI Officer at Avo. &#8220;By bringing Chart Assist and Ask Avo into the MEDITECH Alliance alongside AI Scribe, we can support not only what is said during the encounter, but the clinical reasoning and decisions around it. We&#8217;re excited to continue helping MEDITECH hospitals reduce administrative burden, support better clinical decisions, and improve clinician efficiency.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/artificial-intelligence-in-healthcare-market\"><strong>Artificial Intelligence (AI) in Healthcare Market Report<\/strong><\/a>\u201d, the global artificial intelligence in healthcare market is expected to increase from <strong>USD 40,809.25 million<\/strong> in 2025 to <strong>USD 861,636.63 million <\/strong>by 2034, reflecting strong and sustained growth. The global artificial intelligence in healthcare market is growing at a<strong> CAGR of 40.40%<\/strong> during the forecast period from 2026 to 2034. The rising prevalence of chronic diseases is increasing the demand for continuous monitoring, early diagnosis, and personalized treatment, which AI-powered tools can efficiently support. At the same time, the accelerating adoption of AI and advanced analytics in healthcare is improving clinical decision-making, operational efficiency, and predictive insights across hospitals and research settings. The expansion of digital health, telemedicine, and remote patient monitoring is further generating large volumes of real-time patient data, enabling AI systems to deliver timely interventions and virtual care solutions. Additionally, advances in machine learning, deep learning, and generative AI are enhancing diagnostic accuracy, drug discovery, and personalized medicine capabilities. Collectively, these factors are significantly driving the growth and transformation of the AI in healthcare market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-nicklaus-children-s-hospital-performed-one-of-the-first-transcatheter-fontan-completions-in-the-country-on-a-two-year-old-child-nbsp\"><span class=\"ez-toc-section\" id=\"Nicklaus_Childrens_Hospital_Performed_One_of_the_First_Transcatheter_Fontan_Completions_in_the_Country_on_a_Two-Year-Old_Child\"><\/span><strong>Nicklaus Children&#8217;s Hospital Performed One of the First Transcatheter Fontan Completions in the Country on a Two-Year-Old Child&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 09 September 2026, Nicklaus Children&#8217;s Hospital reported that its Heart Institute had successfully performed one of the first transcatheter Fontan completions in the United States on a two-year-old child with complex congenital heart disease. The procedure used a catheter-based technique to complete the child&#8217;s Fontan circulation, avoiding the need for another open-heart surgery.<\/p>\n\n\n\n<p>The child, who had been born with a double-outlet right ventricle, underwent the minimally invasive intervention using specialized equipment delivered through a blood vessel. Following the procedure, the child recovered well and was discharged home. The transcatheter approach was intended to provide eligible pediatric patients with benefits such as avoiding surgical incisions, reducing hospital stays, and supporting faster recovery compared with conventional surgery. The procedure was conducted by Nicklaus Children&#8217;s Hospital&#8217;s interventional cardiology and cardiovascular surgery teams and highlighted the growing use of less-invasive treatment approaches for children with complex congenital heart defects. The Fontan procedure represents the final planned stage of staged palliation for many children with single-ventricle heart defects by redirecting venous blood directly toward the lungs.<\/p>\n\n\n\n<p><em>&#8220;This achievement reflects an extraordinary level of collaboration and coordination between our surgical and interventional cardiology team,&#8221; said Dr. Sathanandam. &#8220;It demonstrates what is possible when clinical expertise, innovation, and teamwork come together to expand treatment options for children with the most complex heart conditions.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201d<a href=\"https:\/\/www.delveinsight.com\/report-store\/congenital-heart-defect-devices-market\"><strong>Congenital Heart Defect Devices Market Report<\/strong><\/a>,\u201d the global congenital heart defect devices market size is estimated at <strong>USD 3.11 billion<\/strong> in 2023 and is projected to reach <strong>USD 4.45 billion<\/strong> by 2030, growing at a<strong> CAGR of 7.4% <\/strong>during the forecast period from 2024 to 2030. The demand for Congenital Heart Defect Devices is primarily being boosted owing to key factors such as the rising prevalence of congenital heart defects, increasing diagnosis and screening of congenital cardiac abnormalities, growing adoption of minimally invasive and transcatheter procedures, increasing demand for pediatric cardiac interventions, rising awareness regarding early diagnosis and treatment of congenital heart defects, expansion of specialized pediatric cardiac care centers, along with the growing focus on developing safer, smaller, and more effective cardiac devices for pediatric and adult patients. Furthermore, technological advancements in implantable cardiac devices, increasing adoption of catheter-based treatments, growing healthcare expenditure, rising access to advanced cardiac care in emerging markets, and continuous product innovation are expected to further support the growth of the Congenital Heart Defect Devices market during the forecast period from 2025 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-aeye-ds-clinical-trials-published-first-fully-autonomous-diabetic-retinopathy-screening-technology-across-portable-and-tabletop-devices-demonstrates-99-imageability-one-image-per-eye-workflow-and-best-in-class-diagnostic-efficacy-nbsp\"><span class=\"ez-toc-section\" id=\"AEYE-DS_Clinical_Trials_Published_First_Fully_Autonomous_Diabetic_Retinopathy_Screening_Technology_Across_Portable_and_Tabletop_Devices_Demonstrates_99_Imageability_One-Image-per-Eye_Workflow_and_Best-in-Class_Diagnostic_Efficacy\"><\/span><strong>AEYE-DS Clinical Trials Published: First Fully Autonomous Diabetic Retinopathy Screening Technology Across Portable and Tabletop Devices Demonstrates 99% Imageability, One-Image-per-Eye Workflow, and Best-in-Class Diagnostic Efficacy&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 09 September 2026, AEYE Health announced the publication of clinical trial results validating its AEYE-DS autonomous artificial intelligence technology for diabetic retinopathy screening. The findings were published in Frontiers in Digital Health and were based on three prospective, controlled clinical trials involving more than 1,200 patients with diabetes. The studies evaluated AEYE-DS across both portable handheld and tabletop retinal imaging systems. The technology demonstrated more than 99% imageability, enabling the analysis of images from the vast majority of patients, while requiring only one image from each eye. The system also supported screening without routine pupil dilation and was designed to provide automated diagnostic results at the point of care.<\/p>\n\n\n\n<p>The clinical trials reported sensitivity of 92%\u201393% for the portable system and 93% for the tabletop system in detecting more-than-mild diabetic retinopathy. Specificity ranged from 89%\u201394% for the portable system and reached 91.4% for the tabletop system. The technology also achieved 100% sensitivity for severe cases evaluated in the trials. The results strengthened the clinical evidence supporting AI-enabled diabetic retinopathy screening and highlighted the potential of autonomous retinal screening systems to expand testing beyond specialist ophthalmology settings. The portable and tabletop configurations could facilitate integration of diabetic eye examinations into primary-care and other point-of-care environments.<\/p>\n\n\n\n<p><em>&#8220;The data from AEYE-DS&#8217;s three clinical trials speak for themselves. AEYE-DS finally makes diabetic eye exams practical at the point of care: portable and tabletop devices, just one image per eye, no dilation, and best-in-class diagnostic efficacy. No other FDA-cleared solution does any of that,&#8221; said Dr. Zack Dvey-Aharon, Ph.D., Co-Founder and CEO of AEYE Health. &#8220;With this groundbreaking clinical evidence, a screening workflow that can be completed by staff members in just one minute, and seamless EHR integration, we expect AEYE-DS to continue its rapid expansion across the United States and become the new American standard for diabetic eye exams.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/ophthalmic-imaging-equipment-market\"><strong>Ophthalmic Imaging Equipment Market Report<\/strong><\/a>,\u201d the global ophthalmic imaging equipment market was valued at <strong>USD 2.33 billion<\/strong> in 2023 and projected to reach <strong>USD 3.29 billion<\/strong> by 2030. Ophthalmic Imaging Equipment Market is growing at a <strong>CAGR of 5.97%<\/strong> during the forecast period from 2024 to 2030. The demand for ophthalmic imaging equipment is primarily being boosted by the rising prevalence of diabetes and a growing geriatric population base, which has resulted in the increased prevalence of ocular diseases of different etiologies, an increasing number of image-guided surgeries, and technical innovation in product development, which are expected to increase product demand, thereby contributing to the growth of the ophthalmic imaging equipment market during the forecast period from 2024 to 2030.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Emboline Received U.S. FDA 510(k) Clearance for Emboliner\u00ae Embolic Protection System&nbsp; On 09 September 2026, Emboline announced that it had received U.S. FDA 510(k) clearance for its Emboliner Embolic Protection System, supporting the company&#8217;s advancement in the embolic protection device market. The system was developed to capture and remove embolic debris generated during transcatheter heart 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This site is optimized with the Yoast SEO Premium plugin v27.9 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MedTech News | Emboline, Alcon, Avo<\/title>\n<meta name=\"description\" content=\"Emboline\u2019s Emboliner Embolic Protection System; Alcon&#039;s Clareon Monofocal IOL; Shoulder Innovations and ALM Ortho Collaboration\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-emboline-alcon-avo\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MedTech News | Emboline, Alcon, Avo\" \/>\n<meta property=\"og:description\" content=\"Emboline\u2019s Emboliner Embolic Protection System; Alcon&#039;s Clareon Monofocal IOL; Shoulder Innovations and ALM Ortho Collaboration\" \/>\n<meta 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