CORRECTION: RadNet’s DeepHealth Subsidiary Expands FDA Clearance for SmartMammo™ Solution
RadNet's DeepHealth has received expanded FDA 510(k) clearance for its SmartMammo Dx AI algorithm to be compatible with GE HealthCare's Senographe Pristina™ mammography systems. This expansion follows the initial FDA clearance in May 2021 for HOLOGIC systems. The AI-powered software helps identify suspicious soft tissue lesions and calcifications in digital breast tomosynthesis mammograms, assigning specific suspicion levels with enhanced diagnostic accuracy.
The technology has already supported millions of exams through RadNet's Enhanced Breast Cancer Detection program. This new clearance advances DeepHealth's mission to enhance breast cancer screening programs by broadening system compatibility and improving clinical accuracy, operational efficiency, and patient care.
DeepHealth di RadNet ha ricevuto un'estensione dell'approvazione FDA 510(k) per il suo algoritmo AI SmartMammo Dx per essere compatibile con i sistemi di mammografia Senographe Pristina™ di GE HealthCare. Questa estensione segue l'approvazione iniziale della FDA avvenuta a maggio 2021 per i sistemi HOLOGIC. Il software alimentato dall'AI aiuta a identificare lesioni sospette dei tessuti molli e calcificazioni nelle mammografie digitali di tomosintesi, assegnando livelli di sospetto specifici con una maggiore accuratezza diagnostica.
La tecnologia ha già supportato milioni di esami attraverso il programma Enhanced Breast Cancer Detection di RadNet. Questa nuova approvazione avanza la missione di DeepHealth di migliorare i programmi di screening per il cancro al seno ampliando la compatibilità dei sistemi e migliorando la precisione clinica, l'efficienza operativa e la cura dei pazienti.
DeepHealth de RadNet ha recibido una ampliación de la aprobación 510(k) de la FDA para su algoritmo de IA SmartMammo Dx para ser compatible con los sistemas de mamografía Senographe Pristina™ de GE HealthCare. Esta expansión sigue a la aprobación inicial de la FDA en mayo de 2021 para los sistemas HOLOGIC. El software impulsado por inteligencia artificial ayuda a identificar lesiones sospechosas en tejidos blandos y calcificaciones en mamogramas digitales de tomosíntesis, asignando niveles de sospecha específicos con mayor precisión diagnóstica.
La tecnología ya ha respaldado millones de exámenes a través del programa Enhanced Breast Cancer Detection de RadNet. Esta nueva aprobación avanza la misión de DeepHealth de mejorar los programas de detección del cáncer de mama al ampliar la compatibilidad de los sistemas y mejorar la precisión clínica, la eficiencia operativa y la atención al paciente.
RadNet의 DeepHealth는 GE HealthCare의 Senographe Pristina™ 유방촬영 시스템과 호환되도록 SmartMammo Dx AI 알고리즘에 대한 FDA 510(k) 승인을 확대 받았습니다. 이번 확장은 2021년 5월 HOLOGIC 시스템에 대한 최초 FDA 승인을 따른 것입니다. AI 기반 소프트웨어는 디지털 유방 톰모신테시스 유방 촬영 사진에서 의심스러운 연조직 병변 및 석회화 변화를 식별하는 데 도움을 주며, 향상된 진단 정확성으로 특정 의심 수준을 할당합니다.
이 기술은 RadNet의 Enhanced Breast Cancer Detection 프로그램을 통해 수 백만 개의 검사를 지원해 왔습니다. 이번 새로운 승인은 시스템 호환성을 확대하고 임상 정확성, 운영 효율성 및 환자 치료를 개선하면서 DeepHealth의 유방암 검사 프로그램을 향상시키고자 하는 미션을 진전시킵니다.
DeepHealth de RadNet a reçu une extension de son approbation 510(k) de la FDA pour son algorithme d'IA SmartMammo Dx, afin d'être compatible avec les systèmes de mammographie Senographe Pristina™ de GE HealthCare. Cette extension fait suite à l'approbation initiale de la FDA en mai 2021 pour les systèmes HOLOGIC. Le logiciel alimenté par l'IA aide à identifier les lésions suspectes des tissus mous et les calcifications dans les mammographies numériques de tomosynthèse, attribuant des niveaux de suspicion spécifiques avec une précision diagnostique améliorée.
La technologie a déjà soutenu des millions d'examens à travers le programme Enhanced Breast Cancer Detection de RadNet. Cette nouvelle approbation avance la mission de DeepHealth d'améliorer les programmes de dépistage du cancer du sein en élargissant la compatibilité des systèmes et en améliorant la précision clinique, l'efficacité opérationnelle et les soins aux patients.
DeepHealth von RadNet hat eine erweiterte FDA 510(k) Zulassung für seinen SmartMammo Dx KI-Algorithmus erhalten, um mit den Mammographiesystemen Senographe Pristina™ von GE HealthCare kompatibel zu sein. Diese Erweiterung folgt auf die ursprüngliche FDA-Genehmigung im Mai 2021 für HOLOGIC Systeme. Die KI-gestützte Software hilft dabei, verdächtige Weichgewebsverletzungen und Verkalkungen in digitalen Brusttomosynthese-Mammogrammen zu identifizieren, indem sie spezifische Verdachtsstufen mit verbesserter diagnostischer Genauigkeit zuweist.
Die Technologie hat bereits Millionen von Untersuchungen im Rahmen von RadNets Enhanced Breast Cancer Detection Programm unterstützt. Diese neue Genehmigung fördert die Mission von DeepHealth, die Programme zur Brustkrebsfrüherkennung durch die Erweiterung der Systemkompatibilität und die Verbesserung der klinischen Genauigkeit, der operativen Effizienz und der Patientenversorgung zu optimieren.
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- SmartMammo™’s AI algorithm now FDA cleared with GE HealthCare’s Senographe Pristina™, expanding access to enhanced cancer detection.
- The clearance enables RadNet’s DeepHealth and GE HealthCare collaboration to bring together the SmartMammo and Senographe Pristina solutions and transform breast cancer diagnosis.
SOMERVILLE, Mass., Nov. 29, 2024 (GLOBE NEWSWIRE) -- In a release issued under the same headline on Friday, November 29th by RadNet, Inc. (NASDAQ: RDNT), please note that in the third sentence of the first paragraph, the year that SmartMammo Dx was first cleared should be 2021, not 2012. The corrected release follows:
DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc. (NASDAQ: RDNT) and a global leader in AI-powered health informatics, has received expanded FDA 510(k) clearance for its innovative mammography software. SmartMammo Dx, the AI algorithm within SmartMammo1, is now FDA-cleared to be compatible with GE HealthCare’s Senographe Pristina™ mammography systems. SmartMammo Dx was first cleared in May 2021 in conjunction with HOLOGIC mammography systems, where its performance has also been tested and cleared in patients with unilateral breasts and with breast implants. This newly expanded clearance advances DeepHealth’s mission to enhance and expand breast cancer screening programs by broadening system compatibility.
“This FDA clearance allows us to expand access to high-quality breast cancer screening to more patients,” said Kees Wesdorp, President and CEO of RadNet’s Digital Health segment. “By bringing SmartMammo’s improved cancer detection to GE HealthCare’s mammography systems, more providers can harness the power of AI to help redefine radiology workflows and address key challenges across the imaging value chain, to improve speed, clinical accuracy, operational efficiency, and elevate patient care.”
SmartMammo Dx is a key component of DeepHealth’s comprehensive SmartMammo1 solution, delivering advanced AI-driven tools that empower radiologists to interpret digital breast tomosynthesis (DBT) mammograms with greater precision. The software identifies suspicious soft tissue lesions and calcifications and assigns finding-specific and case-specific suspicion levels with increased diagnostic accuracy.
DeepHealth’s FDA-cleared breast cancer diagnostic technologies have already supported millions of exams over the last two years with HOLOGIC mammography systems through the Enhanced Breast Cancer Detection (EBCD) program at RadNet. The expanded FDA clearance with GE HealthCare’s Senographe Pristina should further accelerate the adoption of AI-powered breast cancer screening at RadNet and with other providers.
The FDA clearance underscores DeepHealth and GE HealthCare’s shared commitment to advancing patient-centric, interoperable, and scalable imaging solutions. The two companies aim to set new standards in AI-powered breast imaging to help radiologists deliver better care faster.
For more information about SmartMammo Dx and its impact on breast cancer screening, visit deephealth.com
1 SmartMammo™ comprises multiple components, including SmartMammo Dx (also known as Saige DX), SmartMammo Density, DeepHealth Viewer, and SmartMammo Assure. DeepHealth Viewer is Manufactured by eRAD and Distributed by DeepHealth. Any claims made about SmartMammo™ may reference claims associated with its individual components.
About RadNet, Inc.
RadNet, Inc. is the leading national provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue. RadNet has a network of 399 owned and/or operated outpatient imaging centers. RadNet’s markets include Arizona, California, Delaware, Florida, Maryland, New Jersey, New York and Texas. In addition, RadNet provides radiology information technology and artificial intelligence solutions marketed under the DeepHealth brand, teleradiology professional services and other related products and services to customers in the diagnostic imaging industry. Together with affiliated radiologists, and inclusive of full-time and per diem employees and technologists, RadNet has a total of over 10,000 employees. For more information, visit http://www.radnet.com.
About DeepHealth
DeepHealth is a wholly-owned subsidiary of RadNet, Inc. (NASDAQ: RDNT) and serves as the umbrella brand for all companies within RadNet's Digital Health segment. DeepHealth provides AI-powered health informatics with the aim of empowering breakthroughs in care through imaging. Building on the strengths of the companies it has integrated and is rebranding (i.e., eRAD Radiology Information and Image Management Systems and Picture Archiving and Communication System, Aidence lung AI, DeepHealth and Kheiron breast AI and Quantib prostate and brain AI), DeepHealth leverages advanced AI for operational efficiency and improved clinical outcomes in lung, breast, prostate, and brain health. At the heart of DeepHealth’s portfolio is a cloud-native operating system - DeepHealth OS - that unifies data across the clinical and operational workflow and personalizes AI-powered workspaces for everyone in the radiology continuum. Thousands of radiologists at hundreds of imaging centers and radiology departments around the world use DeepHealth solutions to enable earlier, more reliable, and more efficient disease detection, including in large-scale cancer screening programs. DeepHealth’s human-centered, intuitive technology aims to push the boundaries of what's possible in healthcare. https://deephealth.com/
Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements, including statements regarding the capabilities of RadNet, GE HealthCare, Hologic and DeepHealth’s informatics, hardware and software product portfolios and the collaboration’s impact on radiology practices and healthcare workflow, are expressions of our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, and anticipated future conditions, events and trends. Forward-looking statements can generally be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Because forward-looking statements relate to the future, they are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not place undue reliance on any of these forward-looking statements.
For media inquiries, reach out to:
DeepHealth
Andra Axente
Communications Director
Phone: +31 614 440971
Email: andra.axente@deephealth.com
RadNet, Inc.
Mark Stolper
Executive Vice President and Chief Financial Officer
310-445-2800
FAQ
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