Singular Health (ASX: SHG) Submits FDA 510(k) Application for 3DICOM MD™ Cloud Platform

Singular Health Group Limited (ASX: SHG) has advanced its regulatory pathway by submitting a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its 3DICOM MD™ Cloud platform. The Singular Health FDA 510(k) submission signals the evolution of the company’s previously cleared 3DICOM MD™ Viewer, moving from a desktop application to a cloud-native, browser-based solution with expanded clinical functions and collaboration tools.

This submission is designed to enable Singular Health to scale its recurring revenue model through a software-as-a-medical-device deployment across U.S. healthcare organisations. It follows a rigorous quality and risk-management process to meet U.S. regulatory expectations for advanced medical imaging platforms.

Company Financials

ASX Ticker: SHG
Market Capitalisation: [Data not provided]
Shares on Issue: [Data not provided]
Cash Position (as at 22 Oct 2024): $13.7 million

What makes the Singular Health FDA 510(k) submission important?

The Singular Health FDA 510(k) submission addresses critical barriers that healthcare organisations face when implementing traditional imaging software. Complex IT infrastructure requirements, hardware purchases, training complexity, and lengthy procurement cycles often delay or prevent the adoption of advanced imaging solutions.

By transitioning to a cloud-native architecture, 3DICOM MD™ Cloud removes these implementation hurdles and creates several commercial advantages. Healthcare organisations can onboard the platform without specialised workstation needs or IT infrastructure investments, accelerating deployment timelines.

Furthermore, the cloud-based software-as-a-service model generates predictable recurring revenue streams versus one-time software licence sales. This transition aligns with healthcare’s accelerating cloud adoption following the COVID-19 pandemic, driven by telehealth expansion and remote collaboration requirements across care teams.

How does 3DICOM MD™ Cloud differ from the original viewer?

The evolution from the desktop 3DICOM MD™ Viewer to the cloud-based 3DICOM MD™ Cloud introduces substantial advancements. The original viewer, cleared by the FDA in 2022, operated as a desktop application supporting CT, MRI, and PET scans.

In contrast, 3DICOM MD™ Cloud delivers a browser-based solution supporting CT, MRI, PET, X-ray, and ultrasound imaging modalities. The platform incorporates clinician-optimised workflow enhancements developed in collaboration with Dr Ronny Low, designed to reflect day-to-day use in multidisciplinary care settings.

Critically, the platform was engineered as a scalable foundation for AI marketplace expansion. This positions Singular Health to integrate AI-enabled modules for advanced imaging analytics, differentiating the platform from traditional viewing software.

Why does expanded modality support matter for clinical adoption?

The Singular Health FDA 510(k) submission’s inclusion of X-ray and ultrasound imaging carries significant market implications. X-rays represent the most common medical imaging modality, accounting for approximately 50% of all medical imaging procedures globally.

This expansion enables Singular Health to serve general radiology departments and primary care settings, rather than limiting applications to specialised imaging departments. Most 3D visualisation tools focus exclusively on CT and MRI imaging, making X-ray and ultrasound capability a source of competitive differentiation.

Broader clinical applicability increases the potential number of users per healthcare organisation, expanding revenue potential per customer site. Additionally, broad modality support addresses healthcare’s focus on care coordination and reducing duplicative procedures.

What timeline should investors expect for the FDA review?

Following acceptance of the Singular Health FDA 510(k) submission, the FDA will move to a substantive review. The target decision timeframe is approximately 90 FDA days for a traditional 510(k) pathway, although this period can pause if the FDA requests additional information.

A successful outcome would result in FDA clearance, enabling the marketing and clinical use of 3DICOM MD™ Cloud throughout the United States. This clearance would extend Singular Health’s U.S. regulatory footprint beyond its existing desktop viewer.

Chief Quality Officer Andre Rocha commented on the ASX announcement, stating, “Submitting our 510(k) for 3DICOM MD™ Cloud is a major step in advancing Singular Health’s regulatory pathway… This submission reflects a rigorous quality and risk-management process, and positions the Company to deliver a clinically enhanced, cloud-based platform aligned with U.S. regulatory expectations.”

How does the cloud architecture enable the AI marketplace?

The cloud-native technical foundation is a central component of Singular Health’s commercialisation roadmap. 3DICOM MD™ Cloud is positioned as an extensible marketplace where AI-enabled modules can be integrated for advanced imaging analytics.

Software as a Medical Device (SaMD) refers to software intended for medical purposes without being part of a hardware device. The cloud-based SaMD architecture enables Singular Health to continuously enhance platform capabilities through software updates rather than requiring hardware upgrades.

This marketplace approach creates multiple revenue streams beyond base platform subscriptions. As AI algorithms receive regulatory clearances, Singular Health can offer these as add-on modules, generating additional recurring revenue. By consolidating sharing, viewing, storing, and AI-enabled analysis within a unified platform, Singular Health aims to simplify clinical workflows.

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