Singular Health Group – USD $1.3m U.S. Commercial Contract with PNS Signals First National-Scale Rollout – Healthcare Image Interoperability and Scalable SaaS Revenue
- Noel Ong
- 4 minutes ago
- 7 min read
Announcement
FDA 510(k) Clearance for 3DICOM MD Cloud – 13 January 2026 (view the announcement)
Samso has had a long association with Singular Health, and it has been a long time since we covered the ins and outs of the Singular Health business. Our interest in the Singular Health business is now based on what appears to be a transition from proof-of-concept into contracted commercial deployment within the U.S. healthcare system.
Previous content on Singular Health:
15th January 2021
The Company is addressing a clearly defined inefficiency—medical imaging interoperability—through a regulatory-cleared, enterprise-ready platform with early validation from a large MSO partner. I have not looked into the business much, and I think it may be different from that discussed in 2021.
Singular Health Group Ltd (ASX: SHG) is advancing its U.S. healthcare strategy through the commercialisation of its FDA-cleared 3DICOM™ medical imaging interoperability platform. The company’s near-term focus is on the United States, with initial deployments planned across Puerto Rico, Florida, and Texas through a strategic partnership with Provider Network Solutions (PNS).
The January 2026 update builds on prior disclosures by highlighting a signed USD $1.3 million commercial contract and the operational readiness of the 3DICOM™ platform for scaled rollout across large managed service organisation (MSO) networks.
The Business of the Singular Health Limited: Healthcare Imaging Interoperability
Singular Health is a healthcare technology company focused on unlocking the full value of medical imaging through secure, interoperable data sharing.
Its core product, 3DICOM™, enables encrypted, PACS-agnostic transfer and aggregation of medical imaging records across healthcare networks (Figure 1).
Figure 1: With 3DICOM Solution (source: SHG)
The Company’s strategy targets U.S. MSOs, healthcare organisations, and health plans seeking to reduce redundant imaging, costs, and delays in diagnosis.
Commercialisation is progressing via enterprise licensing, recurring SaaS revenue, and AI-enabled workflow solutions.
Highlights – FDA Clearance Driving U.S. Commercial Readiness
FDA 510(k) clearance granted for 3DICOM MD® Cloud, expanding Singular Health’s regulated product portfolio in the United States and building on prior FDA clearance for the desktop 3DICOM MD® software achieved in October 2022.
Accelerated FDA review completed in 40 days, materially ahead of the typical ~90-day review timeframe, demonstrating the robustness of the regulatory submission and validation process.
Cloud-based, browser-enabled architecture eliminates the need for dedicated hardware or complex desktop installations, lowering adoption barriers for healthcare organisations and enabling faster deployment across distributed clinical networks.
Imaging modality coverage expanded to include X-ray and ultrasound, in addition to CT, MRI, and PET, materially broadening clinical pathways and use cases addressable by the platform.
Significant U.S. market opportunity identified, with an estimated US$16.5 billion total addressable market (TAM) linked to reducing unnecessary duplicate imaging across major imaging modalities.
Leadership Commentary
Singular Health Managing Director & CEO, Denning Chong, commented:
“This clearance, achieved well ahead of time, represents a major milestone for Singular Health and our U.S. strategy 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.”
About the Project
Singular Health’s 3DICOM™ platform addresses a systemic lack of interoperability in medical imaging workflows. Traditional healthcare systems often require repeated scans due to inaccessible prior imaging, resulting in higher costs, patient discomfort, and delayed treatment.
The 3DICOM™ solution enables secure aggregation and sharing of imaging records across hospitals, imaging centres, primary care physicians, and specialists (Figure 2). The platform is HIPAA compliant and aligned with SOC2 Type 2 and ISO 27001 standards, supporting enterprise-grade adoption.
Figure 2: 3DICOM-enabled workflow and benefits diagram (source: SHG)
Near-term Milestones to Watch
Commercial deployment of 3DICOM MD® Cloud in the United States, following FDA 510(k) clearance, enabling marketing and clinical use of the cloud-based platform.
Adoption of the browser-enabled, cloud architecture by healthcare organisations, removing the need for hardware or complex desktop installations and lowering barriers to enterprise-scale implementation.
Expansion of clinical use cases leveraging broader imaging modality support, with X-ray and ultrasound now included alongside CT, MRI, and PET, materially widening addressable workflows.
Progression of U.S. commercial strategy aligned to reducing duplicate imaging, targeting a US$16.5B estimated total addressable market supported by improved interoperability and access to imaging records.
Samso Concluding Comments
From a Samso perspective, this update marks an important stage for Singular Health. The Company is no longer pitching only the size of the problem—it is demonstrating that large healthcare operators are willing to pay for the solution.
The U.S. healthcare market is complex and slow-moving, which makes early enterprise validation particularly significant. A successful pilot within PNS could materially de-risk future MSO and health-plan negotiations.
The emphasis on interoperability, rather than replacing existing systems, aligns well with how healthcare networks actually adopt technology. This positioning may support faster integration and lower switching resistance.
Ultimately, Singular Health is still in an early commercial phase. However, the combination of regulatory-cleared technology, a funded balance sheet, and a signed U.S. contract places the Company firmly on Samso’s watchlist for healthcare-focused growth stories.
It will be a good way to get an update on what is now the business and how they are travelling since we last made touch in 2022.
Market Implications
Singular Health, at the time of writing, has a market capitalisation of AUD $78.49M, which, for me, with a non-mineral resource stock, is not bad. At this junction of the business, I think the upside is still to come. Like all of the "start-up" companies, time and investment are required, and often, the fruits are far from the pains of maintaining the course of the business. The share price chart (Figure 3) is looking like it is establishing a new low or a new high since its bottom in 2024.
Figure 3: Singular Health Group share price chart as of 23rd January 2026. (source: CommSec)
As I mentioned earlier in the blog, Singular Health was being covered by Samso as far back as 2021, and to see that it is still trying its business is a good reason to look deeper. I have reached out to the management for a Coffee with Samso, and let's see if that eventuates sometime after March 2026. For me, this may be a good one to have on the watch screen and do some DYOR.
If they are starting to get the positive responses, sometimes, businesses like these can just go for a run. Canva was founded in 2013, and by 2018, it had a valuation of USD 1B, and in 2021 had achieved a valuation of USD $40B. The ability to interpret imaging information can be a game-changer if the product can get market acceptance, and most importantly, it actually works. Hence, it may be a good idea to keep an eye on Singular Health, or NOT.
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