iCAD's ProFound Detection Version 4.0 Gains FDA Clearance
iCAD announces FDA clearance for ProFound Detection Version 4.0, an AI-powered cancer detection solution for Digital Breast Tomosynthesis (DBT). The new version shows a 22% overall improvement in detecting challenging cancer subtypes, including a 50% improvement in dense breast tissue detection and 60% improvement in invasive lobular cancers identification. The solution features a 6.3% improved AUC over the previous version and introduces prior exam integration capability. The upgrade also delivers 18% improvement in reducing false positives, with 20% fewer vascular calcification marks and 51% fewer non-vascular calcification marks.
iCAD annuncia l'approvazione da parte della FDA per ProFound Detection Version 4.0, una soluzione di rilevamento del cancro supportata da IA per la Tomografia Digitale della Mammella (DBT). La nuova versione mostra un 22% di miglioramento complessivo nel rilevamento di sottotipi di cancro difficili, compresi un miglioramento del 50% nella rilevazione del tessuto mammario denso e un 60% di miglioramento nell'identificazione dei tumori lobulari invasivi. La soluzione presenta un miglioramento dell'AUC del 6,3% rispetto alla versione precedente e introduce la capacità di integrazione con esami precedenti. L'aggiornamento offre anche un miglioramento del 18% nella riduzione dei falsi positivi, con il 20% in meno di segni di calcificazioni vascolari e il 51% in meno di segni di calcificazioni non vascolari.
iCAD anuncia la aprobación de la FDA para ProFound Detection Version 4.0, una solución de detección de cáncer impulsada por IA para la Tomosíntesis Digital de Mama (DBT). La nueva versión muestra una mejora general del 22% en la detección de subtipos de cáncer desafiantes, incluyendo una mejora del 50% en la detección de tejido mamario denso y un 60% de mejora en la identificación de cánceres lobulares invasivos. La solución presenta una mejora del AUC del 6.3% respecto a la versión anterior e introduce la capacidad de integración de exámenes previos. La actualización también proporciona una mejora del 18% en la reducción de falsos positivos, con un 20% menos de marcas de calcificación vascular y un 51% menos de marcas de calcificación no vascular.
iCAD는 디지털 유방 촬영(DBT)을 위한 AI 기반 암 탐지 솔루션인 ProFound Detection Version 4.0의 FDA 승인을 발표했습니다. 새로운 버전은 전체적으로 22% 향상된 성능을 보여주며, 밀도가 높은 유방 조직 탐지에서 50%, 침습성 소엽암 식별에서 60% 향상을 포함하여 어려운 암 아형을 탐지하는 데 개선되었습니다. 이 솔루션은 이전 버전 대비 AUC가 6.3% 향상되었으며 이전 검사 통합 기능을 도입합니다. 또한 이 업그레이드는 잘못된 양성 결과를 18% 줄이는 성과를 내고, 혈관 석회화 마크를 20% 줄이며 비혈관 석회화 마크를 51% 줄입니다.
iCAD annonce l'approbation par la FDA de ProFound Detection Version 4.0, une solution de détection du cancer alimentée par IA pour la Tomosynthèse Mammaire Numérique (DBT). La nouvelle version montre une amélioration globale de 22% dans la détection de sous-types de cancer difficiles, y compris une amélioration de 50% dans la détection des tissus mammaires denses et une amélioration de 60% dans l'identification des cancers lobulaires invasifs. La solution présente une AUC améliorée de 6,3% par rapport à la version précédente et introduit la capacité d'intégration des examens antérieurs. La mise à niveau permet également une amélioration de 18% de la réduction des faux positifs, avec 20% de marques de calcification vasculaire en moins et 51% de marques de calcification non vasculaire en moins.
iCAD gibt die FDA-Zulassung für ProFound Detection Version 4.0 bekannt, eine KI-gestützte Krebsdetektionslösung für die Digitale Brusttomosynthese (DBT). Die neue Version zeigt eine 22%ige Gesamtverbesserung bei der Erkennung herausfordernder Krebsuntertypen, einschließlich einer Verbesserung von 50% bei der Erkennung von dichtem Brustgewebe und einer Verbesserung von 60% bei der Identifizierung invasiver lobulärer Karzinome. Die Lösung bietet eine verbesserte AUC von 6,3% im Vergleich zur vorherigen Version und führt die Möglichkeit der Integration früherer Untersuchungen ein. Das Upgrade bietet auch eine Verbesserung von 18% bei der Reduzierung von falsch-positiven Ergebnissen, mit 20% weniger vaskulären Verkalkungszeichen und 51% weniger nicht-vaskulären Verkalkungszeichen.
- FDA clearance obtained for ProFound Detection Version 4.0
- 22% overall improvement in detecting challenging cancer subtypes
- 50% improvement in dense breast tissue cancer detection
- 60% improvement in identifying invasive lobular cancers
- 18% reduction in false positives
- Expected growth in Annual Recurring Revenue (ARR) through cloud-based deployment
- None.
Insights
The FDA clearance of ProFound Detection Version 4.0 represents a significant technological advancement in breast cancer screening. The
The reduction in false positives, with
These improvements could significantly impact patient outcomes through earlier detection of aggressive cancers, particularly in challenging cases involving dense breast tissue or small tumors under 1cm.
This FDA clearance positions iCAD for substantial revenue growth through multiple channels. The shift to cloud-based deployment and subscription models creates a robust foundation for expanding Annual Recurring Revenue (ARR), offering more predictable revenue streams and higher customer lifetime value. The
With a market cap of
Provides
NASHUA, N.H., Nov. 12, 2024 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”) a global leader in clinically proven AI-powered cancer detection solutions, announced today that its ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT) has received clearance from the U.S. Food and Drug Administration (FDA). This next-generation AI solution, trained using advanced deep learning convolutional neural networks (CNN), offers advancements in cancer detection and specificity, achieving a
With over 20 years of innovation and experience, iCAD was the first to introduce an FDA-cleared AI solution for DBT in 2016. ProFound Detection Version 4.0 now extends that pioneering legacy by offering enhancements in detection and precision. With today’s FDA clearance, ProFound Detection Version 4.0 is now available for implementation in the U.S. Additional global and vendor-specific regulatory expansions are anticipated through 2025.
Beyond its enhanced clinical performance, ProFound Detection Version 4.0 presents substantial growth potential for iCAD. As existing and new customers upgrade to this latest version and adopt cloud-based deployment and subscription programs, iCAD anticipates steady growth in Annual Recurring Revenue (ARR). This strategic shift to the cloud enables facilities to remain at the forefront of AI advancements while benefiting from enhanced scalability, continuous updates, and streamlined operational efficiency.
Compared to previous version 3, ProFound Detection Version 4.0 provides a
50% improvement in identifying cancers within dense breast tissue,60% improvement in identifying invasive lobular cancers,21% improvement in detecting invasive cancers, and38% improvement in identifying cancers smaller than 1 cm
“With FDA clearance of ProFound Detection Version 4.0, iCAD continues to set new benchmarks in cancer detection, especially in the most challenging cases where accurate and early detection is critical,” said Dana Brown, President and CEO, iCAD. “This groundbreaking fourth generation of our AI solution not only enhances detection for cancers feared most by even the expert fellowship-trained breast radiologists, but also reduces the burden of potential false positives, thereby providing clinicians with a highly precise and efficient AI concurrent-reader solution. We believe this advancement strengthens our competitive position and represents a powerful driver for long-term growth.”
“ProFound Detection Version 4.0 will dramatically improve breast cancer detection,” said Dr. Chirag Parghi, MD, MBA, Chief Medical Officer at Solis Mammography. “The newest version’s ability to detect subtle invasive cancers, especially within dense breast tissue, addresses one of the biggest challenges in breast imaging today. The improved precision in ProFound Detection’s lesion marking combined with the option to incorporate prior exams allows for improved clinical accuracy and more efficient reading workflows. Collectively, these upgrades will enhance the AI-enriched interpretation experience leading to meaningful adoption of AI."
Along with improved cancer detection capabilities, ProFound Detection Version 4.0 delivers more precise lesion marking, with an
20% fewer marks related to vascular calcifications, and51% fewer marks related to non-vascular calcifications.
In a significant leap forward, ProFound Detection Version 4.0 enables clinicians to incorporate a prior exam into its AI analysis and case-score/lesion assessment on the current case, emulating the approach radiologists take when interpreting current screening exams with historical context. By integrating prior imaging data, the software provides greater precision and insight, further enhancing clinical decision-making.
iCAD will showcase this next-generation AI, along with its end-to-end breast health AI suite and the recently launched ProFound Cloud deployment solutions, at the upcoming 2024 Radiological Society of North America (RSNA) annual meeting, held in Chicago, IL, from December 1st to December 4th. Visit iCAD’s RSNA event page to learn more and book a live demonstration: https://www.icadmed.com/about/news-events/upcoming-tradeshows-and-meetings/rsna-2024.
About iCAD, Inc.
iCAD, Inc. (NASDAQ: ICAD) is a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outcomes. Headquartered in Nashua, N.H., iCAD’s industry-leading ProFound Breast Health Suite provides AI-powered mammography analysis for breast cancer detection, density assessment and risk evaluation. Used by thousands of providers serving millions of patients, ProFound is available in over 50 countries. In the last five years alone, iCAD estimates reading more than 40 million mammograms worldwide, with nearly
Forward-Looking Statements
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the expansion of access to the Company’s products, improvement of performance, acceleration of adoption, expected benefits of ProFound AI®, the benefits of the Company’s products, and future prospects for the Company’s technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties, and other factors that may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Company’s ability to achieve business and strategic objectives, the willingness of patients to undergo mammography screening, whether mammography screening will be treated as an essential procedure, whether ProFound AI will improve reading efficiency, improve specificity and sensitivity, reduce false positives and otherwise prove to be more beneficial for patients and clinicians, the impact of supply and manufacturing constraints or difficulties on our ability to fulfill our orders, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, product market acceptance, possible technological obsolescence of products, increased competition, government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,” “seek,” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at https://www.icadmed.com and on the SEC’s website at http://www.sec.gov.
CONTACTS
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FAQ
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