GE HealthCare Secures CE Mark for MINItrace Magni Cyclotron and Expands Solid Target Platform

GE HealthCare has announced that its MINItrace Magni cyclotron has secured CE Mark certification. The regulatory milestone coincides with the company broadening its PETtrace Solid Target Platform to support Copper-64 production, expanding the manufacturing infrastructure available to healthcare institutions operating positron emission tomography programmes.

Automated Radioisotope Production

The MINItrace Magni is an automated, self-shielded cyclotron engineered for in-house radioisotope manufacturing. Designed to produce Carbon-11, Fluorine-18, Nitrogen-13, and Oxygen-15, the compact hardware streamlines departmental workflows by automating beam tuning, target irradiation, and target preparation through a three-click operational interface. When integrated with the company’s TRACERcenter Solutions, the system fits into established radiopharmacy setups to accommodate specific tracer manufacturing demands.

Expanding Solid Target Capabilities

Alongside the cyclotron certification, GE HealthCare has added Copper-64 capabilities to its PETtrace Solid Target Platform. This solid-target hardware was initially introduced for Gallium-68 in 2022 and subsequently adapted for Zirconium-89. The latest update increases the range of isotopes that facilities can process using PETtrace equipment.

Copper-64 is utilized in diagnostic imaging and is currently being investigated alongside Copper-67 agents as a potential diagnostic and therapeutic theranostic pairing. Clinical researchers are studying compounds labelled with Copper-64 in prostate cancer as well as human epidermal growth factor receptor 2-positive breast cancer.

Industry Context and Outlook

GE HealthCare molecular imaging vice-president Erez Levy noted that the molecular imaging landscape is evolving due to the expansion of theranostics, the introduction of new PET tracers, and growing clinical demand across oncology, neurology, and cardiology. Levy stated that as tracer portfolios broaden, healthcare providers require reliable access to radioisotopes and operational flexibility to respond to changing clinical needs.

• MINItrace Magni offers automated beam tuning and target preparation via a three-click interface.
• PETtrace Solid Target Platform expansion adds Copper-64 processing capabilities.
• Compounds labelled with Copper-64 are currently under clinical investigation for prostate and breast cancers.

The company couples its cyclotrons and targetry systems with synthesis chemistry and imaging tools to support ongoing research and clinical applications. Additionally, GE HealthCare recently entered an agreement to acquire SOFIE Biosciences, a contract manufacturing organization specializing in PET radiopharmaceuticals, for $945m.