Singular Health Wins Rapid FDA Clearance for Cloud-Based 3D Imaging Platform

Singular Health Group Ltd ( (AU:SHG) ) has provided an update.

Singular Health Group has secured U.S. FDA 510(k) clearance for 3DICOM MD Cloud, a Class II Software as a Medical Device and cloud-based evolution of its previously cleared 3DICOM MD desktop software, allowing the company to market and deploy the platform clinically across the United States. The accelerated 40-day review, well ahead of the typical timeline, underscores the robustness of the submission and enables the company to advance its U.S. commercial strategy with a browser-based solution that removes hardware and complex IT installation requirements. By adding support for X-ray and ultrasound alongside CT, MRI and PET, the cloud platform significantly broadens the range of clinical pathways it can serve and positions Singular Health to address an estimated US$16.5 billion U.S. market opportunity in reducing duplicate imaging, potentially enhancing adoption among large healthcare organisations and strengthening its competitive position in medical imaging software.

The most recent analyst rating on (AU:SHG) stock is a Hold with a A$0.24 price target. To see the full list of analyst forecasts on Singular Health Group Ltd stock, see the AU:SHG Stock Forecast page.

More about Singular Health Group Ltd

Singular Health Group Ltd (ASX: SHG) develops medical imaging software, with a focus on 3D visualisation tools used by healthcare organisations to view and share diagnostic images. Its flagship 3DICOM MD platform, now available in both desktop and cloud-based forms, targets clinical workflows across multiple imaging modalities and is aimed at reducing unnecessary repeat scans and improving access to imaging data in the U.S. healthcare market.

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Technical Sentiment Signal: Buy

Current Market Cap: A$78.49M

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