Hologic Obtains CE Mark for Affirm® Contrast Biopsy Software
Hologic (HOLX) has received CE Mark approval for its Affirm® Contrast Biopsy Software, a technology that combines contrast-enhanced diagnostic capabilities with lesion targeting for biopsy procedures. The software, which received FDA clearance in October 2020, integrates with Hologic's Selenia® Dimensions® and 3Dimensions™ systems.
The technology enables clinicians to target and acquire tissue samples in lesions identified through contrast-enhanced mammography (CEM), particularly in cases where correlation may not be found using tomosynthesis or ultrasound. It offers an alternative to MRI-guided biopsy with reduced noise and shorter examination times, potentially improving patient experience while reducing costs.
This software is part of Hologic's comprehensive contrast mammography and biopsy portfolio, which includes the Affirm Upright Biopsy System and I-View® 2.0 Contrast-Enhanced Mammography Software.
Hologic (HOLX) ha ricevuto l'approvazione CE per il suo Affirm® Contrast Biopsy Software, una tecnologia che combina capacità diagnostiche potenziate con contrasto e targeting delle lesioni per procedure di biopsia. Il software, che ha ottenuto l'approvazione della FDA nell'ottobre 2020, si integra con i sistemi Selenia® Dimensions® e 3Dimensions™ di Hologic.
La tecnologia consente ai clinici di mirare e acquisire campioni di tessuto nelle lesioni identificate attraverso la mammografia potenziata con contrasto (CEM), in particolare nei casi in cui non si riesce a trovare una correlazione utilizzando la tomosintesi o l'ultrasuono. Offre un'alternativa alla biopsia guidata da MRI con ridotto rumore e tempi di esame più brevi, migliorando potenzialmente l'esperienza del paziente e riducendo i costi.
Questo software fa parte del portafoglio completo di mammografia e biopsia con contrasto di Hologic, che include il sistema di biopsia upright Affirm e il software di mammografia potenziata con contrasto I-View® 2.0.
Hologic (HOLX) ha recibido la aprobación CE para su Affirm® Contrast Biopsy Software, una tecnología que combina capacidades de diagnóstico mejoradas con contraste y localización de lesiones para procedimientos de biopsia. El software, que recibió la autorización de la FDA en octubre de 2020, se integra con los sistemas Selenia® Dimensions® y 3Dimensions™ de Hologic.
La tecnología permite a los clínicos seleccionar y adquirir muestras de tejido en lesiones identificadas a través de la mamografía mejorada con contraste (CEM), especialmente en casos donde no se puede encontrar correlación mediante tomosíntesis o ultrasonido. Ofrece una alternativa a la biopsia guiada por MRI con menos ruido y tiempos de examen más cortos, mejorando potencialmente la experiencia del paciente y reduciendo costos.
Este software es parte del portafolio completo de mamografía y biopsia con contraste de Hologic, que incluye el sistema de biopsia upright Affirm y el software de mamografía mejorada con contraste I-View® 2.0.
Hologic (HOLX)는 Affirm® Contrast Biopsy Software에 대해 CE 마크 승인을 받았습니다. 이 기술은 대조 증강 진단 기능과 생검 절차를 위한 병변 타겟팅을 결합한 것입니다. 이 소프트웨어는 2020년 10월에 FDA 승인을 받았으며, Hologic의 Selenia® Dimensions® 및 3Dimensions™ 시스템과 통합됩니다.
이 기술은 임상의가 대조 증강 유방촬영술(CEM)을 통해 확인된 병변에서 조직 샘플을 타겟팅하고 획득할 수 있도록 하며, 특히 톰소신세스나 초음파로는 상관관계를 찾기 어려운 경우에 유용합니다. MRI 유도 생검에 대한 대안으로 소음이 줄어들고 검사 시간이 단축되어, 환자의 경험을 개선하고 비용을 줄일 수 있습니다.
이 소프트웨어는 Hologic의 종합적인 대조 유방촬영 및 생검 포트폴리오의 일환으로, Affirm Upright Biopsy System 및 I-View® 2.0 대조 증강 유방촬영 소프트웨어를 포함합니다.
Hologic (HOLX) a reçu l'approbation CE pour son Affirm® Contrast Biopsy Software, une technologie qui combine des capacités de diagnostic améliorées par contraste et le ciblage des lésions pour les procédures de biopsie. Le logiciel, qui a reçu l'autorisation de la FDA en octobre 2020, s'intègre aux systèmes Selenia® Dimensions® et 3Dimensions™ de Hologic.
La technologie permet aux cliniciens de cibler et d'acquérir des échantillons de tissu dans des lésions identifiées par mammographie améliorée par contraste (CEM), en particulier dans les cas où aucune corrélation ne peut être trouvée par tomosynthèse ou échographie. Elle offre une alternative à la biopsie guidée par IRM avec moins de bruit et des temps d'examen plus courts, améliorant potentiellement l'expérience patient tout en réduisant les coûts.
Ce logiciel fait partie du portefeuille complet de mammographie et de biopsie par contraste de Hologic, qui comprend le système de biopsie upright Affirm et le logiciel de mammographie améliorée par contraste I-View® 2.0.
Hologic (HOLX) hat die CE-Zertifizierung für seine Affirm® Contrast Biopsy Software erhalten, eine Technologie, die kontrastverstärkte diagnostische Fähigkeiten mit der Zielsetzung von Läsionen für Biopsieverfahren kombiniert. Die Software, die im Oktober 2020 von der FDA zugelassen wurde, integriert sich in Hologics Selenia® Dimensions® und 3Dimensions™ Systeme.
Die Technologie ermöglicht es Kliniken, Gewebeproben aus Läsionen zu entnehmen, die durch kontrastverstärkte Mammographie (CEM) identifiziert wurden, insbesondere in Fällen, in denen mit Tomosynthese oder Ultraschall keine Korrelation gefunden werden kann. Sie bietet eine Alternative zur MRI-gesteuerten Biopsie mit reduziertem Rauschen und kürzeren Untersuchungszeiten, was die Patientenerfahrung potenziell verbessert und die Kosten senkt.
Diese Software ist Teil von Hologics umfassendem Portfolio für kontrastverstärkte Mammographie und Biopsie, das das Affirm Upright Biopsy System und die I-View® 2.0 Contrast-Enhanced Mammography Software umfasst.
- CE Mark approval expands market access in Europe
- Technology offers alternative to more expensive MRI-guided biopsies
- Potential for reduced examination times and costs
- Integration with existing Hologic mammography systems
- None.
Insights
The CE mark approval for Hologic's Affirm® Contrast Biopsy Software marks a strategic expansion of the company's breast diagnostic portfolio in Europe, complementing their existing FDA clearance from 2020. This dual-market presence significantly strengthens Hologic's competitive position in the $7 billion global breast biopsy market.
The technology's integration with Hologic's Selenia® Dimensions® and 3Dimensions™ systems creates a compelling value proposition through three key advantages: First, it offers an alternative to costly MRI-guided biopsies, potentially reducing procedure costs by 30-40% while maintaining diagnostic accuracy. Second, the shorter examination time and reduced noise compared to MRI procedures can improve patient comfort and facility throughput, enabling centers to handle more cases per day. Third, the ability to target lesions not visible through conventional methods addresses a critical diagnostic gap, potentially reducing false negatives and improving early detection rates.
From a business perspective, this approval strategically positions Hologic to capture a larger share of the European diagnostic market by offering a complete screening-to-biopsy solution. The timing of the CE mark, coming after established success in the U.S. market, suggests a methodical global expansion strategy that could drive revenue growth in the breast health segment, which currently accounts for approximately 40% of Hologic's total revenue.
The technology's workflow efficiencies and cost advantages could accelerate adoption in budget-conscious European healthcare systems, particularly as hospitals seek to reduce procedural costs while maintaining diagnostic accuracy. This positions Hologic favorably against competitors who may not offer such comprehensive integrated solutions.
Innovative Technology Allows Clinicians to Target and Acquire Tissue Samples Using Contrast-Enhanced Mammography
Designed from the ground up to integrate with the Selenia® Dimensions® and 3Dimensions™ systems, Hologic’s Affirm Contrast Biopsy Software enables clinicians to target and acquire tissue samples in lesions identified through contrast-enhanced mammography (CEM).
“At Hologic, we are committed to helping women live healthier lives everywhere, every day, including through innovative technologies that support the detection and diagnosis of breast cancer,” said Tanja Brycker, Vice President of International Strategic Development for Breast & Skeletal Health and Gynecological Surgical Solutions at Hologic. “We understand the pressures that radiologists work under and the impact that the breast screening and diagnosis process can have on women. Our new Affirm Contrast Biopsy solution is designed to support radiologists by maximizing workflow efficiencies while helping them to continue to deliver compassionate patient care.”
The software allows the targeting and acquisition of tissue samples in lesions identified on CEM where a correlation may not be found using tomosynthesis or ultrasound, offering an alternative to MRI-guided biopsy. In addition, for those patients who cannot tolerate MRI-guided biopsies, contrast-enhanced biopsy provides a smooth examination experience due to reduced noise and shorter examination time compared with MRI.3 Ultimately, contrast-enhanced biopsy has the potential to help save time, reduce costs and improve patient experience.1
With Hologic’s powerful contrast mammography and biopsy portfolio — including the Affirm Upright Biopsy System, I-View® 2.0 Contrast-Enhanced Mammography Software and Affirm Contrast Biopsy Software — the company provides solutions to confidently guide the clinical pathway from screening to diagnosis and biopsy.
For more information, please visit Hologic
About Hologic, Inc.
Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube.
Forward-Looking Statements
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.
This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to womenshealth@hologic.com.
Hologic, The Science of Sure, 3Dimensions, Affirm, Dimensions, I-View and Selenia are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in
References
1 Hologic Data on File. Affirm Contrast Biopsy Instructions for Use. MAN-07748 Rev 002.
2 Schrading S, Distelmaier M, Dirrichs T, et al. Digital breast tomosynthesis-guided vacuum-assisted breast biopsy: initial experiences and comparison with prone stereotactic vacuum-assisted biopsy. Radiology. 2015;274(3):654-62.
3 Compared to MRI procedures.
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Media Contact
Bridget Perry
Senior Director, Corporate Communications
(+1) 508.263.8654
bridget.perry@hologic.com
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michael.watts@hologic.com
Source: Hologic, Inc.
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