Singular Health (ASX:SHG) has announced that the US Food and Drug Administration has granted 510(k) clearance for 3DICOM MD Cloud, the company's cloud-based evolution of its FDA-cleared 3DICOM MD software.
Cleared as a Class II Software as a Medical Device, the platform can now be marketed and used clinically across the United States, marking a major regulatory milestone that strengthens Singular Health’s US commercial strategy.
The cloud-based platform removes traditional adoption barriers by eliminating the need for hardware and complex desktop installations while expanding modality coverage to include X-ray and ultrasound, in addition to CT, MRI, and PET.
The clearance builds on the company's prior FDA approval for the desktop version, submitted in October 2022, and was achieved in just 40 days—well ahead of the typical 90-day review period—reflecting the robustness of testing and validation conducted.
According to Singular Health Managing Director & CEO Denning Chong, the milestone positions the company to scale faster and reduce unnecessary duplicate imaging across healthcare systems.
The expanded capabilities also significantly increase the company's total addressable US market, estimated at approximately US$16.5 billion, by supporting additional clinical pathways and enabling timely access to 3D medical imaging across sites and multidisciplinary teams.
At the time of reporting, Singular Health's share price was $0.26.