Singular Health seeks FDA 510(k) clearance for next-generation 3D medical-imaging and sharing platform
Singular Health Group submits a 510(k) premarket notification to the FDA for its next-generation proprietary imaging platform.
Singular Health submits 510(k) premarket notification to US FDA for 3DICOM MD™ Cloud
The platform is its next-generation version of the FDA-cleared 3DICOM MD™ Viewer
3DICOM MD™ Cloud expands imaging capability to include X-ray and ultrasound, alongside existing CT, MRI and PET; presented in a clinically friendly interface
Special Report: Singular Health has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its next-generation proprietary imaging platform 3DICOM MD™ Cloud.
The move positions Singular Health (ASX: SHG) to expand its US footprint and accelerate adoption of its cloud-based medical-imaging solutions.
3DICOM MD™ Cloud is an advanced version of its previously FDA-cleared software-as-a-medical-device (SaMD) 3DICOM MD™ Viewer and is set to build on success of the previous generation product.
The original 3DICOM MD™ was FDA-cleared in 2022 and designed for standard 2D medical images in DICOM format – primarily CT, MRI, and PET – to be viewed in fully interactive 3D models for clinical review and collaboration.
DICOM stands for ‘digital imaging and communications in medicine’ and is a worldwide standard for medical images.
Broadening use and supporting AI roadmap
Singular Health’s advanced 3DICOM MD™ Cloud platform now supports additional imaging modalities, including X-ray and ultrasound, alongside existing CT, MRI, and PET visualisation, broadening its applicability across clinical settings.
With a solid, cloud-native architecture, 3DICOM MD™ Cloud is designed to scale alongside Singular Health’s future AI roadmap, creating a comprehensive marketplace for sharing, viewing, storing, and AI-enabled analysis of medical images.
Singular Health has also integrated direct clinical input into the development process, collaborating closely with its technical advisor Dr Ronny Low, who has more than 20 years’ experience as a clinical radiologist.
The company says the development process has resulted in a more clinician-friendly interface and workflow designed to better reflect day-to-day use in multidisciplinary care.
The move to secure browser-based access makes it easier for clinicians to retrieve, manage, and view images from any location, without needing complicated desktop software and lengthy IT integrations.
Next steps in the process
After acceptance of Singular Health’s submission, the FDA will move to substantive review, with a target decision timeframe of ~90 days for a traditional 510(k).
This 90-day clock may pause if the FDA requests additional information and will resume once the company addresses such requests.
A successful outcome would result in FDA clearance, confirming substantial equivalence to the appropriate predicate device and enabling marketing and clinical use of 3DICOM MD™ Cloud in the US.
It will extend Singular Health’s US regulatory footprint beyond the existing 3DICOM MD™ Viewer.
Approval would support the company’s strategy to scale recurring revenue through adoption by healthcare organisations and providers, while validating the platform’s cloud-native foundation for AI-enabled modules and marketplace expansion.
Additionally, obtaining clearance would bolster Singular Health’s business case for reducing unnecessary duplicate imaging by enabling a hardware-free, browser-based cloud platform.
The company said this approach eliminated complex desktop and IT installations, minimised implementation friction, and enhanced both usability and timely access to 3D medical imaging for healthcare providers.
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‘Major step’ for Singular Health
Singular Health’s chief quality officer Andre Rocha said it was a proud moment for the team in reaching the important milestone.
“Submitting our 510(k) for 3DICOM MD™ Cloud is a major step in advancing Singular Health’s regulatory pathway for next-generation image visualisation and collaboration applications,” Rocha said.
“This submission reflects a rigorous quality and risk-management process, and positions the Company to deliver a clinically enhanced, cloud-based platform aligned with US regulatory expectations.”
This article was developed in collaboration with Singular Health, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
