Singular Health Group Ltd (ASX:SHG) has received US Food and Drug Administration (FDA) 510(k) clearance for 3DICOM MD® Cloud, marking a key regulatory milestone and strengthening the company’s US commercial strategy.
The clearance covers 3DICOM MD® Cloud as a Class II Software as a Medical Device (SaMD), allowing the cloud-based platform to be marketed and used clinically across the United States. It builds on the company’s prior FDA clearance for the desktop version of 3DICOM MD®, granted in October 2022, and expands Singular Health’s regulated product portfolio.
The FDA clearance strengthens the company's commercial proposition for large healthcare organisations by enabling secure, scalable access to 3D medical imaging across sites and multidisciplinary teams.
The company said it will continue to update the market on material developments as it advances commercialisation of 3DICOM MD® Cloud in the United States.
Product upgrade removes deployment barriers
3DICOM MD® Cloud is a browser-enabled, cloud-based evolution of the company’s medical imaging software, removing the need for specialised hardware or complex desktop and IT installations. Singular Health said this lowers adoption barriers for healthcare organisations and improves usability across distributed clinical teams.
The platform also expands imaging modality support to include X-ray and ultrasound, in addition to CT, MRI and PET, materially widening its clinical applicability and potential use cases.
Managing director and CEO Denning Chong said the clearance was a pivotal step for the company’s US growth plans.
“This clearance, achieved well ahead of time, represents a major milestone for Singular Health and our U.S. strategy. 3DICOM MD® Cloud removes many of the traditional barriers to adoption by eliminating the need for hardware and complex desktop installations, while expanding modality coverage to include X-ray and ultrasound. This positions the Company to scale faster and drive greater impact in reducing duplicate imaging.”
Addressable market expands with broader modality coverage
Singular Health is targeting a significant US market opportunity focused on reducing unnecessary duplicate medical imaging. The company estimates a total addressable market of approximately US$16.5 billion across PET, CT, MRI, X-ray and ultrasound imaging.
The inclusion of X-ray and ultrasound — not supported in the previously cleared desktop version — is expected to materially broaden the range of clinical pathways the platform can support and expand the company’s addressable market.
Accelerated review highlights regulatory readiness
The FDA review was completed in 40 days, significantly faster than the typical 90-day timeframe, reflecting the strength of its regulatory submission and the testing and validation undertaken for the cloud platform.
The 510(k) submission leveraged the existing regulatory foundation of the FDA-cleared desktop software, enabling the company to progress through the pathway efficiently.