Shares in Singular Health Group Ltd (ASX: SHG) were up more than 15% in early trade after the company said it had secured a key approval in the US.
The company said in a statement to the ASX that it had received 510(k) clearance from the US Food and Drug Administration for its product 3DICOM MD Cloud, as a Class II Software as a medical device.
This built on an earlier FDA clearance for the desktop 3DICOM MD software granted in October.
New technology more adaptable
The company said the cloud-based, browser-enabled version of the software removes the need for hardware and complex desktop installations, "lowering adoption barriers and improving usability for healthcare organisations''.
The 510(k) clearance allows the new version of the software to be marketed for use in the US.
The company went on to say:
The clearance represents a significant regulatory milestone and further strengthens Singular Health's U.S. market strategy by expanding its regulated product portfolio. This clearance represents a significant step forward for Singular Health as it expands the company's portfolio of regulated products and strengthens its U.S. commercial strategy.
Singular Health Managing Director Denning Chong said the FDA clearance was achieved well ahead of schedule.
He went on to say:
This clearance, achieved well ahead of time, represents a major milestone for Singular Health and our U.S. strategy. 3DICOM MD® Cloud removes many of the traditional barriers to adoption by eliminating the need for hardware and complex desktop installations, while expanding modality coverage to include X-ray and ultrasound. This positions the Company to scale faster and drive greater impact in reducing duplicate imaging.
Singular Health's 3DICOM technology transforms medical scans into interactive 3D models.
The company said on Tuesday that the potential market for the technology was very large:
The company estimates a significant U.S. opportunity to address unnecessary duplicate imaging, with a total addressable market (TAM) of approximately US$16.5B. This estimate is based on direct imaging costs of US$236.5B and an estimated 7.7% duplicate occurrence across PET, CT, MRI, X-ray and ultrasound1. Importantly, X-ray and ultrasound were not supported in the previously cleared desktop version but are included in 3DICOM MD Cloud, materially expanding the range of clinical pathways and use cases the platform can support and broadening the Company's addressable market.
The company's shares traded as high as 30 cents in early trade, up 15.4%, before settling back to be 9.6% higher at 28.5 cents.
The company was valued at $81.6 million at the close of trading on Monday.
