GE HealthCare Gains FDA Clearance for Aurora & Clarify DL

By

Disclaimer: Images on MEDWIRE.AI are AI-generated for illustrative purposes and are not affiliated with, endorsed by, or representative of any specific company, product, or technology.

GE HealthCare has received FDA 510(k) clearance for its Aurora nuclear medicine system and Clarify DL, a deep learning-based image enhancement tool.

Key Highlights:

  • Aurora is a dual-head SPECT/CT system designed to improve diagnostic accuracy and workflow efficiency.
  • The system offers 40 mm detector coverage—twice that of traditional hybrid systems—supporting use across cardiology, oncology, and neurology.
  • Clarify DL uses deep learning AI to enhance bone SPECT image quality, rated “better” in 98% of clinical evaluations.
  • Both tools aim to support precision medicine and seamless integration into existing clinical workflows.

GE HealthCare says the technologies reflect its ongoing investment in advanced imaging solutions that elevate patient care through smarter diagnostics.

Follow MEDWIRE.AI for imaging breakthroughs in nuclear medicine.