The US Food and Drug Administration (FDA) has granted 510(k) clearance to GE HealthCare’s Aurora nuclear medicine system and Clarify DL.
The company’s dual-head single photon emission computed tomography (SPECT)/computed tomography (CT) technology aims to improve diagnostic offerings and streamline clinical workflows.
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According to the company, the clinicians need sophisticated SPECT/CT solutions that offer diagnostic efficiency and accuracy.
Monitoring and tailoring treatment to each patient rely on high-quality imaging techniques capable of identifying subtle disease markers.
To meet the emerging needs, the company is aiming to integrate its Aurora and Clarify DL seamlessly in several clinical settings to make sure the imaging centres and hospitals adopt the technologies without disturbing their current workflows.
GE HealthCare’s Aurora system is claimed to offer precision imaging, efficient workflows, and an enhanced patient experience.
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By GlobalDataThe system’s 40mm detector provides double the coverage of other hybrid systems’ CT detectors, and its 128-slice plus intelligent imaging offerings support various clinical applications, ranging from cardiology to oncology and neurology, stated the company.
Aurora’s 5/8in crystal NaI detectors are suitable for a diverse array of clinical radiopharmaceuticals, particularly in the fast-growing field of theranostics.
Tailored to build on Aurora’s performance, Clarify DL leverages deep learning technology to improve bone SPECT image quality without increasing the injected dose or scan period.
University Hospitals in Ohio, US, is the inaugural healthcare system in the country to install the company’s technology.
GE HealthCare molecular imaging and computed tomography CEO and president Jean-Luc Procaccini said: “Aurora and Clarify DL are powerful reflections of GE HealthCare’s ongoing investment in next-generation imaging solutions that empower clinicians to practice precision medicine and make more informed decisions.
“By providing diagnostic precision while enabling improved workflow, these nuclear medicine technologies allow clinicians to deliver effective, patient-centred care—ultimately helping drive better outcomes.”
According to the company, in a clinical evaluation, Clarify DL’s image resolution was rated as superior in 98% of the exams, highlighting its potential in the field of nuclear medicine bone SPECT imaging diagnostics.
This development comes after the company announced its financial results for the first quarter of 2025.
