Australia (Commonwealth)_
Singular Health Group, an ASX-listed medtech company, has successfully retained its global regulatory certification, allowing the continued development and manufacturing of its innovative 3Dicom diagnostic medical software in Perth. The company recently disclosed that it has maintained the international standard of certification, known as ISO13485, a pivotal prerequisite for ongoing regulatory approval in the majority of global markets. This certification attests to Singular Health’s commitment to adhering to best-in-class global standards for quality assurance and medical device development.
ISO13485 serves as the primary standard for medical device development and manufacture and is widely adopted by leading medical device regulatory bodies worldwide, serving as a prerequisite for the registration of Class II and higher medical devices. Singular Health’s retention of this certification underscores its dedication to meeting the regulatory and quality requirements of prominent health authorities, including Health Canada, the Therapeutic Goods Administration in Australia, and the United States Food and Drug Agency (FDA) through the Medical Device Single Audit Program.
Singular Health’s flagship product, the 3Dicom medical device, introduces a groundbreaking approach to medical imaging. Designed for use by various medical practitioners such as dentists, surgeons, and radiologists, the software allows the conversion of conventional 2D MRI, CT, and PET scans into immersive 3D images. This transformative capability provides a clearer insight into patients’ medical conditions, facilitating enhanced surgical planning and treatment strategies.
The 3Dicom product line consists of three distinct categories, catering to different needs within the medical field. The 3Dicom MD is utilized by medical practitioners for diagnosis and treatment purposes, while the 3Dicom Patient enables patients to store and manage their medical records, working in conjunction with the 3Dicom MD software. Additionally, the 3Dicom R&D serves as a valuable learning and teaching aid in educational institutions, including universities, globally.
In addition to securing regulatory clearance certification, Singular Health recently relocated its software development activities from its Subiaco-based office to the consolidated Bibra Lake premises. This relocation necessitated notifications to regulatory bodies such as the FDA, British Standards Institute (BSI), and additional quality and regulatory updates, given its status as a Medical Device Establishment (MDE). The company successfully underwent an onsite site verification audit at Bibra Lake, combined with the mandatory annual surveillance audit, submitted for panel review with BSI.
In a notable development, Singular Health announced the receipt of a binding purchase order for its patented 3Dicom technology from Roseman University in Nevada. Roseman University, based in Las Vegas, is the first U.S. college to adopt the 3Dicom R&D software as a medical education tool. This move aligns with projections indicating the U.S. medical education software market to be valued at approximately US$17.6 billion (AU$26.8 billion) by 2027.
Earlier this year, Singular Health secured its first enterprise order for 3Dicom in the U.S., with Techworks 4 Good purchasing 5000 licenses on behalf of American veterans. This initiative aims to empower veterans to upload and share their medical records seamlessly through online, desktop, and mobile applications, enhancing accessibility, portability, and continuity of care.
Late last year, Singular Health’s 3Dicom R&D software was chosen as the medical education program of choice by Majmaah University in Saudi Arabia, with an initial order of 20 annual licenses. This global recognition further solidifies Singular Health’s position as a leading provider of cutting-edge medical imaging solutions, with a commitment to advancing healthcare education and improving patient outcomes.
