GE Healthcare Technologies (GEHC) said Tuesday its StarGuide GX molecular imaging system is pending 510(k) clearance from the US Food and Drug Administration following a recent European regulatory certification.
The diagnostic platform detects a wide spectrum of energy frequencies to evaluate investigational alpha-emitting isotopes deployed in targeted radiotherapy procedures, the company said.
The device integrates dual-sided cadmium zinc telluride sensors to support volume sensitivity alongside Nvidia (NVDA) processing units to accelerate clinical data reconstruction, GE HealthCare said.
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