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GE HealthCare receives FDA 510(k) for deep learning software

GE HealthCare announced it received FDA 510(k) clearance for its Precision DL deep learning image processing software. 

Precision DL utilizes deep learning, a subset of AI and machine learning, to improve image quality on the company’s PET/CT, Omni Legend, and allows for faster scanning time and improved small lesion detection. The software is the company’s latest addition to its Effortless Recon DL portfolio.

“One of the main advantages of moving fully into the future of AI and deep learning is making state-of-the-art imaging accessible to more practices, across more care areas than ever before,” Jan Makela, president and CEO of imaging at GE HealthCare, said in a statement. 


In January, GE completed the spinoff of its healthcare unit, GE HealthCare, which began trading on the Nasdaq as an independent company under the GEHC ticker. GE first announced the spinoff in 2021 as part of a larger effort to separate GE into three companies–GE HealthCare, GE Aerospace and GE Vernova, which focuses on its energy businesses. 

That same month, GE HealthCare announced it hired Dr. Taha Kass-Hout, formerly of Amazon Web Services, as its first chief technology officer. It also acquired French company IMACTIS, which develops computed tomography (CT) interventional guidance technology. 

In February, the company announced it signed an agreement to acquire Caption Health, maker of AI-enabled ultrasound guidance software.

Last month, the health tech giant released its first full quarter earnings as an independent company, reporting $372 million in net income in the first quarter compared with $389 million in the prior-year period and revenue of $4.7 billion, an 8% increase from last year. 

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