Singular Health Group Limited (ASX:SHG) is an Australian medtech company focused on improving medical data interoperability. Its flagship software, 3DICOMTM, enables the seamless sharing of medical images across incompatible systems – reducing inefficiencies and unnecessary costs. In 2025, SHG secured its first major US commercial deal with Provider Network Solutions (PNS), a Managed Service Organisation (MSO) that works with health plans (health insurers), primary care providers and specialists. On 13 January 2026, SHG announced FDA 510(k) clearance for the cloud version of its flagship product, 3DICOM MD® Cloud, improving the prospects for the company to further commercialise its product suite. This is a key development as detailed in this report and we expect several catalysts in 2026 for the company that may drive the share price higher.
20 Jan 2026
FDA clearance for key cloud product
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FDA clearance for key cloud product
Singular Health Group Ltd (SHG:ASX) | 0 0 0.0%
- Published:
20 Jan 2026 -
Author:
Naheed Rahman -
Pages:
4 -
Singular Health Group Limited (ASX:SHG) is an Australian medtech company focused on improving medical data interoperability. Its flagship software, 3DICOMTM, enables the seamless sharing of medical images across incompatible systems – reducing inefficiencies and unnecessary costs. In 2025, SHG secured its first major US commercial deal with Provider Network Solutions (PNS), a Managed Service Organisation (MSO) that works with health plans (health insurers), primary care providers and specialists. On 13 January 2026, SHG announced FDA 510(k) clearance for the cloud version of its flagship product, 3DICOM MD® Cloud, improving the prospects for the company to further commercialise its product suite. This is a key development as detailed in this report and we expect several catalysts in 2026 for the company that may drive the share price higher.