Singular Health Limited (ASX: SHG), a medical technology company focused on creating a seamless healthcare ecosystem by unlocking the value of medical imaging records, has announced that its 3DICOM MD® Cloud has received FDA 510(k) clearance. This cloud-based software is an evolution of their previously FDA-cleared 3DICOM MD® software. The clearance allows for the marketing and clinical use of the platform in the United States as a Class II Software as a Medical Device (SaMD).
The FDA review process was completed in 40 days, significantly faster than the typical 90-day timeframe, reflecting the quality of the submission. The cloud-based deployment of 3DICOM MD® Cloud removes the need for complex hardware and IT installations, reducing adoption barriers for healthcare organisations. Furthermore, the platform now supports X-ray and ultrasound, in addition to CT, MRI, and PET scans, expanding its clinical applicability.
According to Singular Health, the clearance represents a major milestone in their U.S. strategy. The company estimates a significant market opportunity to address unnecessary duplicate imaging, estimating a total addressable market (TAM) of US$16.5 billion in the U.S. Singular Health Managing Director & CEO, Denning Chong, stated that the clearance positions the company to scale faster and drive greater impact in reducing duplicate imaging.
The 510(k) submission built upon the company’s prior FDA clearance for the desktop version of 3DICOM MD®, granted in October 2022. The company believes that 3DICOM MD® Cloud is designed to reduce adoption barriers, improve usability, and facilitate timely access to 3D medical imaging.
