Heidelberg receives FDA clearance of imaging platform module
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Heidelberg Engineering obtained FDA clearance of its Spectralis Flex Module imaging platform, according to a press release.
The Flex Module mounts the company’s Spectralis device on a moveable stand, and an adjustable arm allows it to be used on patients in different positions, helping those who cannot be imaged with a traditional tabletop device, according to the release.
The module includes high-resolution OCT, OCT angiography, fluorescein angiography, indocyanine green angiography, blue laser autofluorescence, multicolor, and widefield and ultra-widefield imaging.
“Receiving FDA clearance for the Spectralis Flex Module fulfills our vision of bringing Heidelberg image quality to all patients, regardless of their age or physical abilities,” Ram Liebenthal, Heidelberg U.S. general manager, said in the release. “We recognized that many patients cannot use a static, table-mounted headrest. By reimagining Spectralis in a more flexible configuration, we can ensure that these patients have access to best-in-class imaging, offering peace of mind to parents, guardians and caretakers.”
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