Diagnostic Use: Which Product(s) and Where?

Singular Health Group, the company behind the 3DICOM Viewer, is a medical technology innovator with a clear mission to improve health literacy and enhance patient outcomes through advanced medical imaging solutions. Headquartered in Bibra Lake, Western Australia, Singular Health has made significant strides in healthcare technology by developing intuitive software that converts 2D medical imaging data (like CT, MRI, and PET scans) into fully interactive 3D models. Their flagship product, 3DICOM, empowers both medical professionals and patients by providing deeper insights into complex medical images.

Diagnostic Status of 3DICOM Products

3DICOM offers three distinct tiers of its software to meet the needs of different user groups: 3DICOM Patient, 3DICOM MD, and 3DICOM R&D.
Each version is tailored to specific applications within the medical field, from patient education to advanced diagnostic and research use.

• 3DICOM Patient is designed primarily for non-professional users, including patients themselves, who wish to better understand their medical conditions through immersive 3D visualization. This version provides users with access to their medical scans (CT, MRI, PET) and allows them to explore their images in an intuitive, user-friendly 3D format. It enhances patient engagement by giving them a clear view of their medical data, but it is not approved for diagnostic use.
• 3DICOM MD is specifically built for medical professionals, including doctors and surgeons, and is designed for more advanced medical imaging needs. This version is equipped with tools for diagnostic analysis and collaboration between healthcare providers. Importantly, 3DICOM MD is the only tier that is cleared for diagnostic use, and it has achieved FDA 510(k) clearance in the United States. This clearance allows the software to be used for diagnostic purposes in clinical settings, making it a powerful tool for healthcare professionals to visualize and analyze complex medical data in 3D. However, it is currently only cleared in the U.S. through this regulatory process.
• 3DICOM R&D is aimed at researchers and developers working in medical fields that require advanced imaging tools and segmentation capabilities. This version supports more sophisticated features, such as AI-based segmentation and medical image manipulation, making it ideal for clinical research and medical device development. It is not designed for diagnostic use but rather for development and experimentation.

In summary, while 3DICOM MD is cleared for diagnostic use in the U.S., both 3DICOM Patient and 3DICOM R&D focus on patient education and research, respectively, without diagnostic clearance. These tiers enable a wide range of users—from patients to researchers and clinicians—to leverage the power of 3D medical imaging at various levels of depth and complexity.

Company Certifications (ISO13485 & MDSAP)

In addition to the FDA clearance, Singular Health is committed to maintaining high standards in quality management. The company has earned ISO 13485 certification, an internationally recognized standard that specifies requirements for a quality management system specific to medical devices. This certification ensures that the design, development, and production of 3DICOM meet strict regulatory requirements and provide consistent quality, safety, and performance.

Further bolstering its global reputation, Singular Health has achieved MDSAP certification (Medical Device Single Audit Program), which harmonizes regulatory requirements across multiple countries, including the U.S., Canada, Japan, Australia, and Brazil.
MDSAP certification demonstrates the company’s ability to meet the diverse and stringent regulatory requirements of these countries, allowing it to expand its market reach and ensure compliance with international medical device standards.

Through these certifications, Singular Health not only guarantees the quality and safety of its products but also positions itself as a trusted leader in the medical imaging technology space. By continuously improving its processes and adhering to the highest regulatory standards, Singular Health is well-equipped to serve a global market, including a growing presence in the United States and beyond.

These achievements highlight Singular Health’s dedication to advancing healthcare technology while maintaining the highest standards in patient safety and regulatory compliance.