Photo courtesy of Artrya
Artrya obtains 510(k) for coronary plaque module AI
ASX-listed Artrya has secured regulatory approval in the United States for its AI-powered module for assessing coronary plaque.
It received the United States Food and Drug Administration's (FDA) 510(k) clearance for the AI module, which provides near real-time assessment of high-risk plaque from coronary CT angiograms.
The approval followed its recent launch in the US in July. Artrya reportedly targets mid-sized hospital systems; it has recently signed a clinical use deal with Tanner Health and has ongoing integrations in Northeast Georgia Health and Cone Health.
Artrya will also validate its newly approved AI module in an upcoming study with partner hospitals.
4DMedical wins 510(k) for CT-based VQ
Fellow ASX-listed company, 4DMedical, has also recently received the US FDA's approval for its non-contrast ventilation-perfusion (VQ) imaging software.
It obtained the 510(k) clearance for CT:VQ, which converts standard chest CT scans into quantitative maps of lung ventilation and perfusion without requiring contrast agents or new equipment. The software-as-a-service integrates with hospital radiology systems and is compatible with over 14,000 CT scanners currently used in the US.
According to 4DMedical, the product is designed to expand access to functional lung imaging, particularly in hospitals without nuclear medicine departments. It has been validated through studies against SPECT scans and early deployments at Stanford University and Brooke Army Medical Center.
$1M federal grant for dental AI project
The Australian government, via the Cooperative Research Centres Projects programme, has provided A$2.2 million ($1.4 million) in grant funding for a project developing what could be the world's first AI-powered tool for the early detection of periodontal disease.
The project, Perio-Detect, aims to advance the detection of periodontal disease from manual probing to a contactless, AI-powered screening process that integrates patient data, cone beam CT scans, and intraoral 3D scans.
Over the next three years, local startup Eyes of AI, digital dental solutions maker 3Shape Australia, CSIRO, and the University of Sydney will work together to develop the tool, which they also plan to validate and pilot in clinical practice. They will also prepare to secure regulatory clearance.
