Apple’s Studio Display XDR gets medical imaging clearance from the FDA

Apple has shared news that the Studio Display XDR‘s medical imaging calibrator has received clearance from the FDA. The company’s 501(k) application has been approved; a 501(k) is an application to show that a device seeking FDA approval is substantially equivalent to one that already has been approved (for those functions that the FDA regulates).

Beginning this week, the Medical Imaging Calibrator for macOS will be available for Studio Display XDR customers. It is not clear if it will require a macOS update or a Studio Display software update, or if it is in the currently-released software in a disabled state and can be enabled with a server-side switch.

The feature will only be available in the United States as it has not secured regulatory approval in other regions yet.

Last week, Apple cut the entry-level Studio Display XDR price from $3,299 to $2,899 and offered refunds to anyone who had purchased one with a VES mount instead of a stand. The option with a tilt-and-height adjustable stand still starts at $3,299.