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GE HealthCare Says StarGuide GX 4D CZT SPECT/CT System Is 510(k) Pending With FDA Following CE Mark

Sep 8, 2026 · 08:08 AM ET· updated 1h ago

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Why It Matters

GE HealthCare made a new medical imaging machine and got approval to sell it in Europe; now they're waiting for the U.S. FDA to approve it too. When companies get these approvals, it shows they're making progress on new products that doctors can use.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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