Singular Health Group (ASX:SHG) received US Food and Drug Administration (FDA) 510(k) clearance for 3DICOM MD Cloud, the cloud-based platform of its FDA-cleared 3DICOM MD software, according to a Tuesday filing with the Australian bourse.
The platform has been cleared as a Class II Software as a Medical Device, allowing for marketing and clinical use of the platform in the US, the filing said.
Shares rose 6% in midday trade on Tuesday.
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