RadNet’s DeepHealth Subsidiary Expands FDA Clearance for SmartMammo™ Solution
RadNet's DeepHealth subsidiary has received expanded FDA 510(k) clearance for its SmartMammo Dx AI algorithm, making it compatible with GE HealthCare's Senographe Pristina™ mammography systems. The software, which helps identify suspicious soft tissue lesions and calcifications in digital breast tomosynthesis (DBT) mammograms, was previously cleared for use with HOLOGIC systems in May 2012. The technology has already supported millions of exams through RadNet's Enhanced Breast Cancer Detection program and aims to improve cancer detection accuracy, operational efficiency, and patient care through AI-powered screening.
RadNet's DeepHealth ha ricevuto un ampliamento dell'approvazione FDA 510(k) per il suo algoritmo AI SmartMammo Dx, rendendolo compatibile con i sistemi di mammografia Senographe Pristina™ di GE HealthCare. Il software, che aiuta a identificare lesioni sospette ai tessuti molli e calcificazioni nelle mammografie digitali tomosintetiche (DBT), era stato precedentemente approvato per l'uso con i sistemi HOLOGIC a maggio 2012. La tecnologia ha già supportato milioni di esami attraverso il programma Enhanced Breast Cancer Detection di RadNet e mira a migliorare la precisione nella rilevazione del cancro, l'efficienza operativa e la cura del paziente grazie allo screening potenziato dall'AI.
RadNet's DeepHealth ha recibido una ampliación de la autorización 510(k) de la FDA para su algoritmo de IA SmartMammo Dx, haciéndolo compatible con los sistemas de mamografía Senographe Pristina™ de GE HealthCare. El software, que ayuda a identificar lesiones sospechosas en tejidos blandos y calcificaciones en mamografías digitales de tomosíntesis (DBT), fue autorizado anteriormente para su uso con sistemas HOLOGIC en mayo de 2012. La tecnología ya ha apoyado millones de exámenes a través del programa Enhanced Breast Cancer Detection de RadNet y tiene como objetivo mejorar la precisión en la detección de cáncer, la eficiencia operativa y la atención al paciente a través de screening impulsado por AI.
RadNet의 DeepHealth 자회사는 SmartMammo Dx AI 알고리즘에 대해 FDA 510(k) 승인을 확장받아 GE HealthCare의 Senographe Pristina™ 유방촬영기 시스템과 호환성을 갖추게 되었습니다. 이 소프트웨어는 디지털 유방 단층촬영(DBT) 유방촬영에서 의심스러운 연조직 병변과 석회화를 식별하는 데 도움을 주며, 2012년 5월에 HOLOGIC 시스템과 함께 사용하기 위해 이전에 승인된 바 있습니다. 이 기술은 RadNet의 Enhanced Breast Cancer Detection 프로그램을 통해 이미 수백만 건의 검사를 지원했으며, AI 기반 스크리닝을 통해 암 탐지 정확도, 운영 효율성 및 환자 치료를 개선하는 것을 목표로 하고 있습니다.
RadNet's DeepHealth a reçu une extension de l'approbation FDA 510(k) pour son algorithme AI SmartMammo Dx, le rendant compatible avec les systèmes de mammographie Senographe Pristina™ de GE HealthCare. Le logiciel, qui aide à identifier des lésions suspectes dans les tissus mous et des calcifications dans les mammographies numériques en tomosynthèse (DBT), avait déjà été approuvé pour une utilisation avec les systèmes HOLOGIC en mai 2012. La technologie a déjà soutenu des millions d'examens grâce au programme Enhanced Breast Cancer Detection de RadNet et vise à améliorer la précision de la détection du cancer, l'efficacité opérationnelle et les soins aux patients grâce à un dépistage alimenté par l'IA.
RadNet's DeepHealth Tochtergesellschaft hat eine erweiterte FDA 510(k) Genehmigung für ihren SmartMammo Dx KI-Algorithmus erhalten, wodurch dieser mit den Mammographiesystemen Senographe Pristina™ von GE HealthCare kompatibel wird. Die Software hilft dabei, verdächtige Weichgewebeläsionen und Verkalkungen in digitalen Brusttomosynthese(DBT)-Mammographien zu identifizieren und wurde bereits im Mai 2012 für die Verwendung mit HOLOGIC-Systemen genehmigt. Die Technologie hat bereits Millionen von Untersuchungen im Rahmen des Enhanced Breast Cancer Detection-Programms von RadNet unterstützt und zielt darauf ab, die Genauigkeit der Krebsdiagnose, die operative Effizienz und die Patientenversorgung durch KI-gestützte Screenings zu verbessern.
- Expanded FDA clearance enables broader market access and potential revenue growth
- Successfully supported millions of exams over two years with existing systems
- Partnership with GE HealthCare expands market reach and adoption potential
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Insights
The expanded FDA clearance for SmartMammo™ with GE HealthCare's Senographe Pristina™ represents a significant market opportunity for RadNet. This compatibility expansion beyond HOLOGIC systems effectively doubles the potential market reach for the AI solution. The technology has already proven its value through millions of exams over two years, indicating strong market validation.
The integration with GE HealthCare's systems is particularly strategic as GE holds approximately
- 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) -- 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 2012 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
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