Browsing Tag
Australian Register of Therapeutic Goods
4 posts
4DMedical wins Australian CT:VQ approval as ASX:4DX faces Medicare reimbursement test
4DMedical has gained regulatory access to its home market for CT:VQ, but the commercial value of Australia’s large CT scanner network will depend on hospital implementation, clinical confidence and Medicare reimbursement.
Avecho Biotechnology clears Phase III insomnia interim review as ASX:AVE surges 40%
Avecho Biotechnology’s CBD insomnia trial will continue with its original 519-patient design after an independent monitoring board found that predefined efficacy and safety requirements had been satisfied.
OncoSil Medical (OSL:ASX) has pancreatic cancer data momentum, but investors now need adoption proof
OSL has TRIPP-FFX data, TGA approval and FDA pathway momentum. The bigger test is whether OncoSil can turn evidence into adoption.
Cardiex (ASX: CDX) gets TGA nod for CONNEQT Pulse: Can it reignite investor confidence?
Cardiex (ASX: CDX) secures TGA approval for CONNEQT Pulse device. Explore how this milestone could reshape its commercial and investor outlook in 2025.