Hermes Medical Solutions receives 510(k) FDA clearance for Voxel Dosimetry
Stockholm – October 18, 2019
Hermes Medical Solutions has received 510(k) FDA clearance for its Voxel Dosimetry TM product. The product has previously been CE-marked.
Voxel Dosimetry TM provides estimates (deterministic) of absorbed radiation dose at voxel level as a result of administrating one of the supported radionuclides and providing a 3-dimensional dose map.
Hermes Medical Solutions´ Voxel Dosimetry TM supports the 7 most common isotopes; Ga68, I123, I131, In111, Lu177, Tc99m and Y90.
The Voxel Dosimetry TM workflow consists of the following steps:
- SPECT/CT or PET/CT DICOM data loading from the data manager (e.g. PACS)
- Registration of different time-points to a common reference study
- Generation and integration of voxel-level time-activity curves
- Voxel-level absorbed dose calculation using a Monte Carlo method
- Saving of the absorbed dose map back to the data manager (e.g. PACS) in DICOM format
“This is an important step towards the holy grail in medical imaging, Theranostics”, says Hermes Medical Solutions´ CEO Tom Francke. “Voxel Dosimetry TM is the most advanced dosimetry product on the market,
which was also recognized by the FDA. It supports all the most commonly used isotopes. It is now both CE-marked and FDA-approved”.
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from quantitative image reconstruction to voxel-level absorbed dose distribution. Nuclear Medicine Communications 2017;
Gustafsson J, Brolin G, Cox M, Ljungberg M, Johansson L, Gleisner KS. Uncertainty propagation for SPECT/CT-based renal dosimetry
in Lu-177 peptide receptor radionuclide therapy. Phys Med Biol. 2015;60(21):8329–8346
Contact: Tom Francke, firstname.lastname@example.org