Singular Health Group Ltd (ASX:SHG)

ALERT: Price-sensitive ASX Announcement for SHG

Current share price for SHG : $0.210 -0.05 (-19.23%)⁺

Announcement

FDA 510(k) Clearance for 3DICOM MD Cloud

Release

13 Jan 2026 9:45AM

Price at Release

$0.260

Full Release

Summary

Singular Health Group Ltd has announced that their 3DICOM MD® Cloud software has achieved FDA 510(k) clearance as a Class II Software as a Medical Device (SaMD), marking a significant milestone in enhancing the company's U.S. commercial strategy. The clearance process, completed in a swift 40 days, highlights the robustness of the regulatory submission. This cloud-based deployment eliminates hardware requirements, improving accessibility for healthcare organizations while expanding imaging support to include X-ray and ultrasound. The 3DICOM MD® Cloud aims to address the estimated US$16.5 billion U.S. market opportunity for reducing duplicate imaging.

Key Points

FDA 510(k) clearance for 3DICOM MD® Cloud as a Class II Software as a Medical Device (SaMD).
Accelerated FDA review conducted in 40 days.
Cloud-based deployment enhances accessibility and usability.
Expanded imaging modality support, including X-ray and ultrasound.
Significant U.S. market opportunity estimated at US$16.5B.
Strengthening of Singular Health’s U.S. market strategy.

IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.