Latest news with #BreakthroughDeviceDesignation
Business Wire
29-07-2025
- Business
- Business Wire
Modella AI and illumiSonics Announce Successful Research Compatibility Between Virtual H&E Imaging and Generative AI-Powered Pathology Diagnostic Platform
BOSTON & WATERLOO, Ontario--(BUSINESS WIRE)-- Modella AI, a leader in generative and agentic artificial intelligence for biomedicine, and illumiSonics Inc., a leader in label-free optical imaging and computational pathology, today announced successful research demonstrating compatibility between illumiSonics' research-use only Multi-Laser Imaging (MLI™) system and Modella AI's research-use only PathChat™ DX platform, which has been granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). These novel study findings support the potential of an end-to-end, fully digital pathology workflow—from label-free tissue imaging to AI-enabled diagnostic interpretation—conducted without chemical staining or tissue damage. 'Enabling diagnostic-grade AI inference from label-free slides is a transformative step forward and advances the vision of digital-first pathology workflows that preserve tissue integrity and can streamline diagnostic throughput,' said Jill Stefanelli, CEO Share In the joint study, the illumiSonics' MLI system produced virtual H&E (Hematoxylin and Eosin-like) images from unstained skin tissue resections showing various malignant features. These de-identified images were analyzed using the PathChat DX platform, which had no prior exposure or training on any form of virtual histology. Diagnostic interpretations from the PathChat DX platform were compared to consensus reads by eight board-certified pathologists with expertise in dermatologic pathology who reviewed both the virtual images and matched chemical H&E slides. Concordance between PathChat DX and expert pathologists was extremely high, demonstrating the feasibility of a fully digital, AI-assisted workflow from unstained whole slides to clinical diagnosis. 'Enabling diagnostic-grade AI inference from label-free slides is a transformative step forward and advances the vision of digital-first pathology workflows that preserve tissue integrity and can streamline diagnostic throughput,' said Jill Stefanelli, CEO of Modella AI. 'While PathChat DX remains research-use only, its compatibility with diverse imaging outputs like those from the MLI™ platform reinforces the adaptability and promise of our generative and agentic AI platform.' Results of this novel research study underscore the advantages of label-free imaging over chemical staining that is used in traditional pathology workflows, which is irreversible, labor-intensive, and can interfere with downstream molecular testing. illumiSonics' MLI platform produces high-resolution virtual H&E images without dyes or tissue destruction, highlighting its potential value in clinical settings that prioritize tissue preservation for additional molecular testing. and precision medicine applications. 'illumiSonics is proud to collaborate on research that explores new possibilities for stain-free, digital pathology,' said John Mackey, CEO of illumiSonics Inc. 'Our MLI system is designed to generate morphologically rich, label-free images suitable for computational analysis in research environments. This compatibility study with PathChat DX demonstrates the potential for next-generation virtual histology to drive fully automated diagnostic pipelines, unlocking new possibilities in clinical diagnosis, precision medicine, and translational research.' About Modella AI Modella AI is a Boston-based biomedical AI company dedicated to advancing healthcare through the development of cutting-edge generative and agentic AI technologies. Its mission is to enhance diagnostic accuracy and access through intelligent, scalable platforms that empower healthcare providers. Visit for more information. About illumiSonics Inc. illumiSonics Inc. is a biomedical technology company developing non-destructive, label-free imaging platforms for high-content tissue analysis. Its patented technology platform enables high-resolution optical sectioning and digital reconstruction of tissue architecture without the need for dyes, stains, or tissue damage—unlocking unprecedented flexibility for clinical diagnostics, research, and biopharmaceutical development. Learn more at Disclaimer: PathChat™ DX and the illumiSonics MLI™ platform are research-use only devices and are not commercially available outside of research use. The FDA Breakthrough Device Designation for PathChat DX does not imply FDA clearance or approval. This press release contains forward-looking statements based on current assumptions and forecasts. Modella AI and illumiSonics assume no obligation to update these statements to reflect future events or developments.
National Post
29-07-2025
- Health
- National Post
Modella AI and illumiSonics Announce Successful Research Compatibility Between Virtual H&E Imaging and Generative AI-Powered Pathology Diagnostic Platform
Article content BOSTON & WATERLOO, Ontario — Modella AI, a leader in generative and agentic artificial intelligence for biomedicine, and illumiSonics Inc., a leader in label-free optical imaging and computational pathology, today announced successful research demonstrating compatibility between illumiSonics' research-use only Multi-Laser Imaging (MLI™) system and Modella AI's research-use only PathChat™ DX platform, which has been granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). These novel study findings support the potential of an end-to-end, fully digital pathology workflow—from label-free tissue imaging to AI-enabled diagnostic interpretation—conducted without chemical staining or tissue damage. Article content In the joint study, the illumiSonics' MLI system produced virtual H&E (Hematoxylin and Eosin-like) images from unstained skin tissue resections showing various malignant features. These de-identified images were analyzed using the PathChat DX platform, which had no prior exposure or training on any form of virtual histology. Diagnostic interpretations from the PathChat DX platform were compared to consensus reads by eight board-certified pathologists with expertise in dermatologic pathology who reviewed both the virtual images and matched chemical H&E slides. Concordance between PathChat DX and expert pathologists was extremely high, demonstrating the feasibility of a fully digital, AI-assisted workflow from unstained whole slides to clinical diagnosis. Article content 'Enabling diagnostic-grade AI inference from label-free slides is a transformative step forward and advances the vision of digital-first pathology workflows that preserve tissue integrity and can streamline diagnostic throughput,' said Jill Stefanelli, CEO of Modella AI. 'While PathChat DX remains research-use only, its compatibility with diverse imaging outputs like those from the MLI™ platform reinforces the adaptability and promise of our generative and agentic AI platform.' Article content Results of this novel research study underscore the advantages of label-free imaging over chemical staining that is used in traditional pathology workflows, which is irreversible, labor-intensive, and can interfere with downstream molecular testing. illumiSonics' MLI platform produces high-resolution virtual H&E images without dyes or tissue destruction, highlighting its potential value in clinical settings that prioritize tissue preservation for additional molecular testing. and precision medicine applications. Article content 'illumiSonics is proud to collaborate on research that explores new possibilities for stain-free, digital pathology,' said John Mackey, CEO of illumiSonics Inc. 'Our MLI system is designed to generate morphologically rich, label-free images suitable for computational analysis in research environments. This compatibility study with PathChat DX demonstrates the potential for next-generation virtual histology to drive fully automated diagnostic pipelines, unlocking new possibilities in clinical diagnosis, precision medicine, and translational research.' Article content About Modella AI Article content Modella AI is a Boston-based biomedical AI company dedicated to advancing healthcare through the development of cutting-edge generative and agentic AI technologies. Its mission is to enhance diagnostic accuracy and access through intelligent, scalable platforms that empower healthcare providers. Visit for more information. Article content About illumiSonics Inc. Article content illumiSonics Inc. is a biomedical technology company developing non-destructive, label-free imaging platforms for high-content tissue analysis. Its patented technology platform enables high-resolution optical sectioning and digital reconstruction of tissue architecture without the need for dyes, stains, or tissue damage—unlocking unprecedented flexibility for clinical diagnostics, research, and biopharmaceutical development. Learn more at Article content PathChat™ DX and the illumiSonics MLI™ platform are research-use only devices and are not commercially available outside of research use. The FDA Breakthrough Device Designation for PathChat DX does not imply FDA clearance or approval. This press release contains forward-looking statements based on current assumptions and forecasts. Modella AI and illumiSonics assume no obligation to update these statements to reflect future events or developments. Article content Article content Article content Article content Article content
Yahoo
29-07-2025
- Business
- Yahoo
Modella AI and illumiSonics Announce Successful Research Compatibility Between Virtual H&E Imaging and Generative AI-Powered Pathology Diagnostic Platform
BOSTON & WATERLOO, Ontario, July 29, 2025--(BUSINESS WIRE)--Modella AI, a leader in generative and agentic artificial intelligence for biomedicine, and illumiSonics Inc., a leader in label-free optical imaging and computational pathology, today announced successful research demonstrating compatibility between illumiSonics' research-use only Multi-Laser Imaging (MLI™) system and Modella AI's research-use only PathChat™ DX platform, which has been granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). These novel study findings support the potential of an end-to-end, fully digital pathology workflow—from label-free tissue imaging to AI-enabled diagnostic interpretation—conducted without chemical staining or tissue damage. In the joint study, the illumiSonics' MLI system produced virtual H&E (Hematoxylin and Eosin-like) images from unstained skin tissue resections showing various malignant features. These de-identified images were analyzed using the PathChat DX platform, which had no prior exposure or training on any form of virtual histology. Diagnostic interpretations from the PathChat DX platform were compared to consensus reads by eight board-certified pathologists with expertise in dermatologic pathology who reviewed both the virtual images and matched chemical H&E slides. Concordance between PathChat DX and expert pathologists was extremely high, demonstrating the feasibility of a fully digital, AI-assisted workflow from unstained whole slides to clinical diagnosis. "Enabling diagnostic-grade AI inference from label-free slides is a transformative step forward and advances the vision of digital-first pathology workflows that preserve tissue integrity and can streamline diagnostic throughput," said Jill Stefanelli, CEO of Modella AI. "While PathChat DX remains research-use only, its compatibility with diverse imaging outputs like those from the MLI™ platform reinforces the adaptability and promise of our generative and agentic AI platform." Results of this novel research study underscore the advantages of label-free imaging over chemical staining that is used in traditional pathology workflows, which is irreversible, labor-intensive, and can interfere with downstream molecular testing. illumiSonics' MLI platform produces high-resolution virtual H&E images without dyes or tissue destruction, highlighting its potential value in clinical settings that prioritize tissue preservation for additional molecular testing. and precision medicine applications. "illumiSonics is proud to collaborate on research that explores new possibilities for stain-free, digital pathology," said John Mackey, CEO of illumiSonics Inc. "Our MLI system is designed to generate morphologically rich, label-free images suitable for computational analysis in research environments. This compatibility study with PathChat DX demonstrates the potential for next-generation virtual histology to drive fully automated diagnostic pipelines, unlocking new possibilities in clinical diagnosis, precision medicine, and translational research." About Modella AI Modella AI is a Boston-based biomedical AI company dedicated to advancing healthcare through the development of cutting-edge generative and agentic AI technologies. Its mission is to enhance diagnostic accuracy and access through intelligent, scalable platforms that empower healthcare providers. Visit for more information. About illumiSonics Inc. illumiSonics Inc. is a biomedical technology company developing non-destructive, label-free imaging platforms for high-content tissue analysis. Its patented technology platform enables high-resolution optical sectioning and digital reconstruction of tissue architecture without the need for dyes, stains, or tissue damage—unlocking unprecedented flexibility for clinical diagnostics, research, and biopharmaceutical development. Learn more at Disclaimer: PathChat™ DX and the illumiSonics MLI™ platform are research-use only devices and are not commercially available outside of research use. The FDA Breakthrough Device Designation for PathChat DX does not imply FDA clearance or approval. This press release contains forward-looking statements based on current assumptions and forecasts. Modella AI and illumiSonics assume no obligation to update these statements to reflect future events or developments. View source version on Contacts press@
Associated Press
24-07-2025
- Health
- Associated Press
CDx Diagnostics Receives FDA Breakthrough Device Designation for Its WATS3D Test System for Esophageal Cancer
Novel AI-powered laboratory test for diagnosis of Barrett's esophagus, with or without dysplasia SUFFERN, NEW YORK / ACCESS Newswire / July 24, 2025 / CDx Diagnostics announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for its proprietary WATS3D diagnostic system, a 'first-of-a-kind' AI-powered digital pathology system using wide area transepithelial sampling for the diagnosis of Barrett's esophagus and early neoplastic alterations in patients at risk for disease progression. 'The Breakthrough Device Designation recognizes what the volume of clinical data has shown: the WATS3D Test improves the ability to detect dysplasia in Barrett's esophagus, offering patients and physicians an improved method of detection of patients at risk of development of esophageal cancer,' said Robert Odze, MD, a leading gastrointestinal pathologist. To meet the requirements for FDA Breakthrough Device Designation, CDx Diagnostics submitted technical and clinical evidence from large multi-center studies showing that the WATS3D Test is 'more effective' than the Seattle biopsy protocol for the diagnosis of Barrett's esophagus, dysplasia and esophageal cancer. 'With data from greater than 23,000 patients, the WATS3D Test continues to demonstrate its potential to detect early-stage neoplastic disease that might be missed with conventional biopsies,' said Karen Hoffman, MD, Director of R&D at CDx Diagnostics. 'This designation recognizes the science behind our platform and supports our ongoing efforts to improve early detection of patients at risk.' The WATS3D Test System leverages proprietary artificial intelligence (AI) enabled algorithm for analysis of high-resolution digital pathology using novel 3-dimensional images from specimens collected using the WATS3D brush to identify precancerous and cancerous cells and assess the risk of progression to cancer. The WATS3D System was developed by CDx Diagnostics and is performed in the company's CLIA-certified, CAP accredited, New York state licensed clinical laboratory in Suffern, NY. For more information, visit or contact us at [email protected]. About CDx Diagnostics CDx Diagnostics' mission is to Empower Physicians with Innovative Technology to Prevent Esophageal Cancer, One Patient at a Time. CDx Diagnostics is changing the landscape of cancer prevention and diagnosis through innovative AI-driven digital pathology solutions developed and performed in the company's CLIA-certified, CAP accredited clinical laboratory in Suffern, New York. The company's first advanced diagnostic test- the WATS3D Test system powered by the WATS3D Esophageal AI Algorithm - has FDA Breakthrough Device Designation for the diagnosis of Barrett's esophagus (BE), with and without dysplasia. About the WATS3D Test System The WATS3D Test system is an AI-powered digital pathology test system that helps prevent the progression of neoplasia via more effective identification of Barrett's esophagus (BE), low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). Developed and performed by CDx Diagnostics, the WATS3D Test leverages artificial intelligence (AI) enabled analysis using the WATS3D Esophageal AI Algorithm and 3D digital imaging of samples collected using a WATS3D brush to identify precancerous and cancerous cells and evaluate the risk of progression to cancer. The WATS3D Test has been used to analyze over 400,000 patient samples to identify those requiring earlier intervention, reduce time to treatment, and improve patient outcomes. Contact Information William Standwill Marketing [email protected] 845-777-7000 SOURCE: CDx Diagnostics press release
Business Upturn
18-06-2025
- Health
- Business Upturn
Orchestra BioMed Showcases AVIM Therapy as Purpose-Built Solution for Hypertensive Heart Disease at CSI Frankfurt 2025
Presentation underscores unique potential for atrioventricular interval modulation ('AVIM') therapy to manage blood pressure in older, high-risk patients who have indicators of diastolic dysfunction and progression to heart failure with preserved ejection fraction ('HFpEF') Hypertensive heart disease represents over 7.7 million U.S. patients, the same population with hypertension and elevated cardiovascular risk cited in the recent FDA Breakthrough Device Designation ('BDD') for AVIM therapy NEW HOPE, Pa., June 18, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, 'Orchestra BioMed' or the 'Company'), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the presentation of key clinical insights into the role of AVIM therapy for the treatment of high-risk hypertension at the Congenital, Structural, and Valvular Heart Disease Interventions ('CSI') 2025 Meeting. The data highlight AVIM therapy's unique potential to address hypertensive heart disease, a significant and under-recognized cardiovascular syndrome that affects a growing segment of the aging hypertension population. The talk, 'Atrioventricular Interval Modulation (AVIM) Therapy for Hypertension and HFpEF,' will be delivered by Daniel Burkhoff, M.D., Ph.D., Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation and clinical advisor to Orchestra BioMed. Dr. Burkhoff will spotlight the clinical utility of AVIM therapy as a novel, device-based approach to blood pressure management designed specifically for patients with hypertensive heart disease. This population has increased risk for major adverse cardiac events and currently lacks sufficient therapeutic options. The presentation will take place on June 18, 2025, at 3:33pm CEST / 9:33am ET as part of the ' Interventions for Chronic Heart Failure ' session. Dr. Burkhoff commented, 'Hypertensive heart disease is not a singular diagnosis, but a high-risk cardiovascular syndrome driven by longstanding, uncontrolled high blood pressure which significantly increases the likelihood of adverse clinical outcomes such as stroke, myocardial infarction, diastolic dysfunction and progression to heart failure. The data I will review at CSI explore how AVIM therapy may offer a unique treatment specifically catered to this group of patients leveraging a mechanism of action designed to reduce cardiac preload and modulate autonomic nervous system responses to reduce blood pressure and improve cardiovascular function. This represents a potential paradigm shift in how we approach blood pressure management using tailored interventions designed to directly impact the complex pathophysiology of high-risk hypertension.' The presentation will cover: The clinical burden and therapeutic gaps in managing patients with high-risk hypertension and increased risk of heart failure; in managing patients with high-risk hypertension and increased risk of heart failure; The growing body of clinical and mechanistic evidence demonstrating AVIM therapy's potential to lower blood pressure and improve cardiac function; and demonstrating AVIM therapy's potential to lower blood pressure and improve cardiac function; and Details on the BACKBEAT global pivotal study, currently enrolling patients with uncontrolled hypertension who are indicated for a dual-chamber pacemaker. The study is being conducted in collaboration with Medtronic, the global leader in cardiac pacing therapy. 'AVIM therapy was purpose-built to address the complex and underserved needs of patients with hypertensive heart disease, a subgroup often overlooked by conventional therapy,' said Avi Fischer, M.D., Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed. 'As a programmable, pacemaker-integrated solution, AVIM therapy has the potential to fit seamlessly into existing electrophysiology practices while opening the door to better outcomes in a large, underserved population. Dr. Burkhoff's presentation at CSI Frankfurt further reinforces the growing clinical interest in AVIM therapy and highlights the significant opportunity to transform care of hypertensive heart disease, especially given our recently granted BDD status, which applies directly to this patient profile.' About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit , and follow us on LinkedIn . References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'expect,' 'should,' 'would,' 'plan,' 'predict,' 'potential,' 'seem,' 'seek,' 'future,' 'outlook' and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, implementation and design of the Company's planned and ongoing pivotal trials, realizing the clinical and commercial value of the Company's product candidates, the potential safety and efficacy of the Company's product candidates, and the ability of the Company's partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company's commercial product candidates and ongoing regulation of the Company's product candidates, if approved; the timing of, and the Company's ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading 'Item 1A. Risk Factors' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading 'Item 1A. Risk Factors' in the Company's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMed [email protected]
