Claritas NucMed Technologies has cleared regulatory requirements for establishing its subsidiary, Claritas NucMed Tech Brazil, to advance the commercialisation of its nuclear medicine software solutions.
Claritas’ software device is designed to meet the challenges of the nuclear medicine sector in Brazil, including environmental impact, high costs, and access issues.
Through its approved distributor New Vida Medicamentos e Productos, the subsidiary is set to deploy and collaborate on positron emission tomography (PET) and single photon emission computed tomography (SPECT) software suites with medical institutions in the country.
The registration process for Claritas NucMed’s software products is underway with ANVISA, Brazil’s medical device regulator.
These products are designed for accelerated and reduced isotope scans and automated lesion detection.
Claritas NucMed Tech Brazil managing director Dr Fernando Salis said: “In terms of the number of PET-CT scans alone, the current estimated number stands at about 20,000 per month, up from only 1,800 per month ten years ago.
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By GlobalData“Despite growth rates that are estimated at 7% per year, there are shortages with demand outstripping supply due to the long scanning time and the challenges of high cost, short life and transportation issues of the isotopes.
“This is the perfect time for the introduction of solutions from Claritas NucMed, which could help to improve efficiencies, reduce costs and provide patient benefits.”
In May 2024, Claritas HealthTech announced the completion of iPETcertum, a new software device designed to automate the detection, delineation, and quantification of isotope uptake in PET scans.
This device already obtained US Food and Drug Administration (FDA) 510k clearance and is commercially available.