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GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics

Shots: The US FDA has received 510(k) submissions for SIGNA MRI technology, unveiled at RSNA 2025, to enhance diagnostics with advanced imaging innovations SIGNA Bolt focuses on high-performance 3.0T imaging with ultra-high gradients, AI-enabled workflows, & research-grade flexibility, while SIGNA Sprint with Freelium emphasizes accessibility through a helium-minimal (<1% helium usage) ventless 1.5T system designed for installation…

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GE HealthCare Reports the FDA Premarket Authorization of Pristina Recon DL for Mammography

Shots:  The US FDA has granted PMA to Pristina Recon DL, enabling the integration of deep learning with iterative reconstruction to deliver high-quality digital breast tomosynthesis (DBT) images without increasing patient radiation dose Pristina Recon DL utilizes 2 sequential deep learning models to separate signal from noise, with the first model reconstructing high-fidelity 3D volumes…

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Intelerad

GE HealthCare to Acquire Intelerad for $2.3B

Shots: GE HealthCare has entered into an agreement to acquire Intelerad, expanding its cloud-enabled & AI-powered solutions portfolio As per the deal, GE HealthCare will acquire Intelerad for a purchase price of $2.3B in cash; closing is expected in H1’26 Acquisition will add Intelerad’s cloud-enabled radiology & cardiology imaging platforms & outpatient enterprise workflow solutions…

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Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians

Shots: Sutter Health and GE HealthCare signed a 7yrs. strategic collaboration agreement (Care Alliance), to enhance access to imaging services for patient and clinician experiences in California. This will enable faster appointments, quicker imaging results, and more consistent care Sutter Health's key initiatives include a fast technology program to deploy advanced AI imaging tools…

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GE HealthCare

GE HealthCare Reports the US FDA’s Approval of Flyrcado (Flurpiridaz F 18) PET Radiotracer for Improved CAD Diagnosis 

Shots:     The US FDA has approved Flyrcado injection as a PET MPI agent to diagnose CAD, with its launch planned in early 2025   The effectiveness of Flyrcado  was assessed under the P-III (AURORA) study in comparison with both invasive coronary angiography as a standard and SPECT MPI to identify CAD    In addition, GE HealthCare secured…

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United Imaging Healthcare Receives CE Mark for Dual Wide-Coverage CT Systems

Shots: United Imaging Healthcare has received CE Mark certification for uCT SiriuX and uCT SiriuX Ultrix, described as the world’s first dual wide-coverage CT family, enabling commercial availability across the EU Built on a Twin-Ring Gantry architecture, the systems combine dual-wide 16cm Ultrix detectors with 2 liquid-metal-bearing X-ray tubes to support synchronized whole-organ dynamic imaging,…

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Gona Aziz at HLTH Europe 2026 on the Convergence of AI & 5T MRI: United Imaging’s Strategy for Advancing Precision Healthcare 

Shots  United Imaging is advancing the future of radiology through the convergence of ultra-high-field imaging and AI, with the uMR Jupiter 5T enabling unprecedented anatomical and functional visualization while next-generation AI transforms imaging data into actionable clinical insights that support earlier diagnosis, precision medicine, and personalized patient care.  At HLTH Europe 2026, the company highlighted how 5T whole-body MRI expands clinical…

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ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients

Shots: The P-III (LATITUDE) trial assessed Cabenuva (cabotegravir + rilpivirine) in 453 adults facing adherence challenges, where 306 virally suppressed pts were randomized to Cabenuva (Q4W; n=152) or ART (QD, PO; n=154), with results published in The NEJM At 48wks., Cabenuva reduced the cumulative risk of regimen failure (1EP) to 22.8% vs 41.2%, with fewer virologic failures…

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Get Tailored Highlights from the 44th Annual J.P. Morgan Healthcare Conference

Shots: The 44th Annual J.P. Morgan Healthcare Conference, taking place January 12–15, 2026 in San Francisco, California, stands as the most influential healthcare investment event on the global calendar. Widely recognized as the industry’s premier forum, the conference brings together global biopharma leaders, high-growth innovators, cutting-edge technology companies, and the investment community shaping the future…

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