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MRI Food and Drug Administration (FDA)

Knobbe Martens

FDA Clears Sonic DL™ for Cardiac MRI Scans

Knobbe Martens on

On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™.  GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI images within a single heartbeat....more

Rivkin Radler LLP

FDA Issues Medical Device Safety Guidance For MRI Facilities

Rivkin Radler LLP on

On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted...more

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