GE HealthCare Technologies announced that the U.S. Food and Drug Administration has granted pre‑market authorization for its Pristina Recon DL platform, a deep‑learning 3‑D reconstruction engine that improves breast‑cancer detection by delivering higher‑resolution images while keeping radiation doses unchanged or lower.
Pristina Recon DL uses a neural‑network model trained on thousands of mammograms to reduce image artifacts, sharpen micro‑calcification clusters, and enhance mass visibility. In a recent study, radiologists preferred images produced by the platform in 99.1% of reviews, and the system demonstrated superior detection of clinically relevant lesions compared with conventional reconstruction methods.
The authorization expands GE HealthCare’s Pristina Via™ line, allowing existing users to upgrade without replacing hardware. The company estimates that the new capability will strengthen its 20% installed‑base share in the U.S. mammography market, a position it has held since 2022, and could drive incremental revenue as more facilities adopt AI‑enhanced workflows.
GE HealthCare’s Q3 2025 earnings showed revenue of $5.1 billion, up 6% year‑over‑year, and an adjusted EPS of $1.07, beating consensus by $0.02. Management attributed the beat to disciplined cost management and a favorable mix of high‑margin AI and imaging services, while noting that tariff impacts weighed on net income. The company raised its full‑year 2025 adjusted EPS guidance to $4.51–$4.63, reflecting confidence in continued demand for its digital‑health solutions.
CEO Peter Arduini highlighted the Pristina Recon DL approval as a “strategic milestone” that underscores GE HealthCare’s commitment to AI‑driven diagnostics. He noted that the platform aligns with the company’s precision‑care strategy, which integrates smart devices, cloud analytics, and AI to improve patient outcomes and operational efficiency.
Market reaction to the announcement was positive, with GE HealthCare shares rising nearly 2.2% on the day of the news. Analysts cited the FDA clearance as a key driver, emphasizing the potential for the platform to capture market share from competitors such as Hologic and Siemens Healthineers and to support the company’s broader digital‑health growth trajectory.
The Pristina Recon DL launch positions GE HealthCare to capitalize on the projected expansion of the digital‑health imaging market, which is expected to grow as screening programs adopt AI tools to improve accuracy and reduce false positives. The company’s recent acquisition of Intelerad for $2.3 billion further strengthens its cloud‑first imaging ecosystem, creating a compelling value proposition for radiology practices seeking integrated AI solutions.
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