Singular Health Group has advanced its U.S. commercial footprint with the deployment of 500 new licences under its PNS contract and secured FDA clearance for its cloud-based 3DICOM MD® platform, positioning the company for significant growth.
- Deployment of 500 additional licences under PNS contract underway
- USD 500,000 payment triggered by Stage 2 rollout progress
- Life Radiology pilot moves to full patient deployment in Miami
- FDA 510(k) clearance received for 3DICOM MD® Cloud platform
- Multi-million-dollar project request submitted to U.S. House of Representatives
Sustained Commercial Momentum in the U.S.
Singular Health Group Limited (ASX, SHG) has reported a quarter marked by steady execution and strategic advances in its U.S. expansion. The company’s ongoing contract with Provider Network Solution (PNS) saw the commencement of deploying an additional 500 licences of its 3DICOM MD® software, following the successful rollout of 250 licences earlier. This progress has triggered a further USD 500,000 payment, underscoring the tangible commercial traction Singular Health is achieving.
Early feedback from PNS indicates the technology is exceeding expectations in reducing duplicate medical imaging, a costly issue estimated to affect nearly 7.7% of imaging procedures in the U.S. healthcare system. Singular Health estimates this represents a potential addressable market of approximately US$16.5 billion, highlighting the scale of opportunity ahead.
Advancing Clinical Validation and Patient Experience
The Life Radiology pilot in Miami has progressed beyond technical validation into full patient deployment, integrating Singular Health’s 3DICOM™ Gateway with existing imaging systems. This transition replaces outdated CD-ROM distribution of medical images with secure, cloud-based access, enhancing patient convenience and operational efficiency. The move is expected to pave the way for broader adoption of the platform nationwide, further embedding Singular Health’s solutions within the U.S. medical imaging ecosystem.
Regulatory Milestones and Intellectual Property Strength
Post-quarter, Singular Health secured FDA 510(k) clearance for its 3DICOM MD® Cloud platform, a significant regulatory achievement that expands the platform’s clinical applicability to include X-ray and ultrasound alongside CT, MRI, and PET imaging. This cloud-based, browser-accessible solution removes barriers to adoption by eliminating the need for specialised hardware or complex installations, facilitating faster and broader deployment across healthcare providers.
Additionally, the company renewed its ISO 13485 certification and received a positive patentability assessment from the World Intellectual Property Organisation for its proprietary Medical File Transfer Protocol (MFTP) technology. This validation of core intellectual property strengthens Singular Health’s competitive position and supports its mission to deliver secure, interoperable imaging solutions.
Strategic Partnerships and Growth Pipeline
Singular Health has submitted a confidential, multi-million-dollar project proposal to the U.S. House of Representatives in collaboration with Florida International University (FIU), aiming to establish a statewide medical imaging repository for Florida’s Medicaid program. The company is also nearing finalisation of a memorandum of understanding with FIU and advancing discussions with Texas-based Verda Healthcare and Athena Health, a major electronic health record provider. These partnerships could significantly extend the reach of Singular Health’s platform across multiple healthcare networks.
With a strong balance sheet providing approximately eight quarters of cash runway, the company is well-positioned to capitalise on these opportunities. Operating expenses rose modestly due to increased research and development and the expansion of U.S. commercial operations, including the onboarding of a new Chief Commercial Officer.
Looking Ahead
As Singular Health moves into 2026, the company’s focus remains on scaling its 3DICOM™ platform across the U.S. and international markets. The combination of regulatory approvals, expanding commercial deployments, and strategic partnerships sets a promising stage for material revenue growth. Investors will be watching closely for updates on licence deployments, contract awards, and further integration with healthcare IT systems.
Bottom Line?
Singular Health’s regulatory wins and expanding U.S. partnerships signal a pivotal phase in its growth trajectory, with the next quarters critical for converting opportunity into revenue.
Questions in the middle?
- How will the confidential multi-million-dollar project with the U.S. House of Representatives impact revenue timing?
- What are the prospects and timelines for broader adoption of the 3DICOM platform across other U.S. healthcare networks?
- How will integration with Athena Health and other clinical platforms influence market penetration and competitive positioning?