Australia's Singular Health hits two-month high on FDA clearance for medical imaging tech

Singular Health

13/01/2026 01:07

** Shares of Australia's Singular Health Group SHG.AX rise as much as 15.4% to A$0.30, their highest level November 13

** The biotech co says the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for 3DICOM MD® Cloud, which is a cloud evolution of co's FDA approved medical imaging device

** 3DICOM MD® Cloud has been cleared as a Class II Software as a Medical Device, enabling marketing and clinical use of the platform in the United States, co says

** Stock gained 13.3% in 2025, and is up 7.8% YTD

 (Reporting by Shruti Agarwal in Bengaluru)

 ((Shruti.Agarwal@thomsonreuters.com))