GE HealthCare Receives FDA Clearance for Aurora, Clarify DL

GE HealthCare has received FDA 510(k) clearance for its Aurora nuclear medicine system and Clarify DL, an advanced dual-head SPECT/CT designed to enhance diagnostic capabilities and streamline clinical workflows. The Aurora system offers double the detector coverage of other hybrid systems and supports a wide range of clinical applications, including cardiology, oncology, and neurology. Clarify DL utilizes deep learning technology to improve bone SPECT image quality without increasing scan time or injected dose, with clinical evaluations rating its image resolution as better in 98% of exams. University Hospitals in Ohio became the first U.S. healthcare system to install this technology, which is intended to facilitate precision medicine and personalized care through high-quality imaging and efficient integration into existing clinical environments. These innovations aim to empower clinicians to make more informed decisions and deliver patient-centered care. GE HealthCare positions Aurora and Clarify DL as significant advancements in nuclear medicine and AI-driven imaging.