Singular Health has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its 3Dicom MDTM Software-as-a-Medical-Device (SaMD). 

3Dicom MDTM is designed for use by medical practitioners of all specialities, including radiologists and dentists, for the diagnostic viewing of Digital Imaging and Communication in Medicine (DICOM) scans.

Plus, it was developed for a post-COVID clinical environment, and features telehealth functionality with in-built remote control, VoIP calling, and text chat for remote collaboration for CT, MRI, and PET scans.

The FDA510(k) review process involves an initial 90-day review period, which can be extended should the FDA have additional questions or discussions arising from the dossier.

US$885.3m medical imaging software market

A successful result means Singular Health (ASX:SHG) will have to appoint a US-based agent prior to marketing and selling its diagnostic 3Dicom MDTM software within the United States.

“A successful review by the FDA will see Singular Health gain access to the vast US Medical Imaging Software market, valued at US$885.3 million in 2020, with the ability to market the MD tier of the 3Dicom software for diagnostic usage,” chairman Howard Digby said.

“Development on Singular Health’s 3Dicom Surgical software for segmentation, medical 3D printing, and implant planning has been occurring concurrent with the 3Dicom MDTM software development and is well progressed for its own anticipated 510(k) submission.”




This article was developed in collaboration with Singular Health Group, 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.