TGA

organization

Last mentioned: Feb 27, 2026

Timeline

  1. TGA Approval

    Australian regulatory body approves the platform for clinical use in Australia.

  2. TGA Approval

    Australian regulatory body approves the Virtual Nodule Clinic for clinical use.

  3. CE Mark

    Virtual Nodule Clinic receives CE marking for expansion into European markets.

  4. Series A Funding

    Company raises $14M to scale its AI clinical platform globally.

  5. Series A Funding

    Company raises $14M to scale its AI platform globally.

  6. FDA Clearance

    Optellum receives first-of-its-kind FDA clearance for AI lung cancer decision support.

  7. FDA Clearance

    Optellum receives first-of-its-kind FDA clearance for AI lung cancer decision support.

Stories mentioning TGA 2

product-launch Bullish

Optellum Secures TGA Approval for AI Lung Cancer Diagnostic in Australia

Optellum has received regulatory clearance from Australia’s Therapeutic Goods Administration (TGA) for its AI-powered Virtual Nodule Clinic. This milestone allows the company to deploy its lung cancer early-detection technology across the Australian healthcare system, marking a major expansion into the Asia-Pacific market.

3 sources
fda-approval Bullish

Optellum Secures TGA Approval for AI Lung Cancer Solution in Australia

Optellum has received regulatory clearance from Australia’s Therapeutic Goods Administration (TGA) for its AI-driven lung nodule management platform. The approval enables the deployment of the Virtual Nodule Clinic to help Australian clinicians identify and treat early-stage lung cancer more effectively.

3 sources