FDA guidance spurs adoption of change control plans for radiology AI devices
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By
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Kathryn Wighton
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September 16, 2026
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3 min
By
Kathryn Wighton
September 16, 2026
by Kathryn Wighton
September 16, 2026
The radioactive diagnostic drug is indicated in patients aged 1 month or older and is used in conjunction with other diagnostic evaluations.
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Rare MAC organisms on lung biopsy and an overlooked exposure history shifted the diagnosis after prolonged immunosuppression.
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