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BD Receives FDA 510(k) Clearance for EnCor EnCompass™ Breast Biopsy and Tissue Removal System
Prnewswire· 2026-01-15 11:50
Core Insights - BD has received FDA 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System, which is set to launch in early 2026, marking a significant advancement in breast health technology [1][2]. Product Overview - The EnCor EnCompass™ Biopsy System is designed to enhance the breast biopsy experience by allowing clinicians to perform procedures across various breast imaging platforms using a single integrated system [2][5]. - Key features include multi-modality use, adjustable vacuum strengths, 360° sampling capability, enhanced visualization tools, and a choice of probe sizes (12G, 10G, and 7G) to accommodate different lesion types [7]. Company Commitment - BD emphasizes its commitment to developing patient-centered solutions that improve early detection and diagnosis of breast diseases, reflecting its ongoing focus on addressing the needs of clinicians and patients [2][3][5]. - The company aims to enhance the safety and efficiency of care delivery while supporting clinical processes through innovative technologies [6].
Hologic's Breast Health Rebounds, Takes Spotlight in Buyout Deal
ZACKS· 2025-11-07 13:41
Core Insights - Hologic (HOLX) achieved a turnaround in its Breast Health division, with revenues increasing by 4.8% to $393.7 million, driven by strong interventional product sales and improved U.S. sales execution [1][8] - The company is undergoing a strategic shift with a proposed takeover by Blackstone and TPG, valued at up to $79 per share, highlighting the strategic importance of the Breast Health division [4][8] Revenue Performance - Breast Health revenues rose 4.8% to $393.7 million, primarily due to strong sales of interventional products and the inclusion of Endomagnetics [1][8] - On an organic basis, excluding divested business sales, the division still achieved a growth of 3.3% [1] Market Dynamics - At the beginning of the fiscal year, management anticipated a slowdown in gantry placements after several quarters of double-digit growth, leading to challenging comparisons [2] - While capital sales faced difficulties, recurring service revenues continued to grow, aligning with Hologic's long-term strategy to diversify revenue streams [2] Leadership and Strategy - A key development was the appointment of new leadership, which reorganized the sales force to better align with distinct skill sets, aiming to enhance performance in commercial channels [3] - The company implemented a refined end-of-life strategy for older gantries and began selling Endomagnetics products directly, moving away from a distributor model [3] Competitive Landscape - GE Healthcare reported revenues of $5.1 billion in Q3 2025, up 4% year-over-year, indicating strong performance in imaging and related businesses [5] - Becton, Dickinson and Company (BD) posted revenues of $5.89 billion in Q4 2025, reflecting an 8.3% year-over-year increase, with positive growth in its Diagnostic Solutions business [6] Stock Performance and Valuation - Hologic shares have increased by 2.9% year-to-date, outperforming the industry average growth of 0.3% [7] - The company is trading at a forward 12-month price-to-sales (P/S) ratio of 3.85X, which is lower than the industry average of 4.28X [9]