SHG.ASX: FDA 510(k) Clearance for 3DICOM MD Cloud

FDA 510(k) Clearance for 3DICOM MD Cloud

Stock	Singular Health Group Ltd (SHG.ASX)
Release Time	13 Jan 2026, 9:45 a.m.
Price Sensitive	Yes

This feature provides summaries of price-sensitive announcements for companies followed by users on InvestorPA. The summaries are generated by large language models so please interpret with care.

Singular Health Secures FDA Clearance for 3DICOM MD Cloud

Key Points

Expansion of Singular Health's regulated product portfolio with FDA 510(k) clearance for 3DICOM MD® Cloud
Accelerated FDA review completed in 40 days, well ahead of typical ~90 calendar day timeframe
Cloud-based, browser-enabled deployment removes the need for hardware and complex desktop or IT installations

Full Summary

Singular Health Group Ltd (ASX: SHG) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for 3DICOM MD® Cloud, the company's cloud-based evolution of its previously FDA-cleared 3DICOM MD® software. 3DICOM MD® Cloud has been cleared as a Class II Software as a Medical Device (SaMD), enabling marketing and clinical use of the platform in the United States. The clearance represents a significant regulatory milestone and further strengthens Singular Health's U.S. market strategy by expanding its regulated product portfolio. The 510(k) submission leveraged the company's prior FDA clearance for the desktop version of 3DICOM MD®, which was granted in October 2022. The review process was concluded in just 40 days, well ahead of the typical ~90 calendar day timeframe, demonstrating the quality and robustness of the submission. The cloud-based, browser-enabled deployment of 3DICOM MD® Cloud removes the need for hardware and complex desktop or IT installations, lowering adoption barriers and improving usability for healthcare organizations. 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. Singular Health estimates a significant U.S. opportunity to address unnecessary duplicate imaging, with a total addressable market (TAM) of approximately US$16.5B.

Outlook

The FDA clearance represents a significant step forward for Singular Health as it expands the company's portfolio of regulated products and strengthens its U.S. commercial strategy. The cloud-based, browser-enabled deployment of 3DICOM MD® Cloud is designed to reduce adoption barriers, improve usability, and facilitate timely access to 3D medical imaging across sites and multidisciplinary teams.