Aesculap, Inc. Receives 510(k) Clearance for Aesculap Aeos® Robotic Digital Microscope DIR800 Capability

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Aesculap, Inc. announced today its receipt of FDA 510(k) clearance for DIR800 3D digital infrared fluorescence for use with its Aesculap Aeos Robotic Digital Microscope. This clearance further enhances the fluorescence capabilities of the microscope which already includes DUV400 3D digital ultraviolet mode.

The company notes the DIR800 is an accessory for the Aesculap Aeos Robotic Digital Microscope, powered by True Digital Surgery, and is used in viewing intraoperative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency in neurosurgery. It also aids in the visual assessment of intraoperative blood flow and vessel patency in bypass neurosurgical procedures.

With DIR800, the Aesculap Aeos Robotic Digital Microscope produces excitation light to illuminate the fluorescence properties of Indocyanine Green (ICG). The generated fluorescence signal depicts the distribution of the infrared dye in the patient’s blood vessels during surgery.

DIR800 combines infrared fluorescence technology with 3D digital visualization while also allowing the surgeon and OR team to share the same high-quality live view and slow motion playback on multiple 3D 4K monitors. Backlight illumination aids visualization of nearby non-fluorescing structures without the need to switch back to white light.

Another key benefit is heads-up positioning to free the surgeon from the microscope ocular tether, allowing the surgeon, not the microscope, to dictate ergonomics.