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MedTech

Claritas NucMed iPET Software Cleared by ANVISA in Brazil

  • cGxPwire Editor's avatar By cGxPwire Editor
  • March 9, 2026

March 09, 2026 — New York, London, and São Paulo

A major advancement in nuclear medicine imaging technology has been announced as Claritas NucMed Technologies Ltd confirmed that its Brazilian subsidiary has secured regulatory clearance from ANVISA to market the Claritas iPET™ medical imaging software in Brazil. The approval enables hospitals and diagnostic imaging centers across the country to deploy a software-based solution designed to significantly reduce PET scan time and lower isotope radiation exposure while maintaining high-quality diagnostic imaging results. The clearance marks an important step in expanding advanced medical imaging technologies within Brazil’s growing nuclear medicine sector, where demand for cancer diagnostics and precision imaging continues to rise.

Regulatory Clearance Enables Advanced PET Imaging Technology

The authorization from ANVISA, Brazil’s national health regulatory authority, allows Claritas NucMed Tech Brazil S.A. to distribute and commercialize Claritas iPET™ software nationwide. The solution will be distributed locally through New Vida Medicamentos e Productos Ltda., an authorized distributor of medical devices and a wholly owned subsidiary of Claritas NucMed Brazil. The software has already received regulatory clearance in multiple international jurisdictions, including the United States through approval by the U.S. Food and Drug Administration, demonstrating the growing global adoption of the platform.

Claritas iPET™ is a software medical device designed to enhance PET imaging efficiency by enabling accelerated scans while using significantly reduced radiopharmaceutical isotope doses without compromising diagnostic accuracy. Using advanced image processing and quantification algorithms, the software enhances images obtained during shortened scans, allowing clinicians to maintain high diagnostic confidence even when imaging time is reduced. For patients undergoing PET-CT or PET-MRI imaging procedures, this technology can deliver shorter scan durations, lower radiation exposure, and improved overall patient comfort.

According to company leadership, the clearance represents a key milestone in the company’s strategy to expand its presence in Latin America’s rapidly growing healthcare technology market. Dr. Fernando Salis, CEO of Claritas NucMed Tech Brazil and a practicing nuclear medicine physician, noted that the platform’s deployment will allow healthcare providers to improve diagnostic accuracy while simultaneously enhancing workflow efficiency and reducing radiation exposure for patients undergoing nuclear imaging procedures.

Growing Demand for Nuclear Medicine Imaging in Brazil

The approval of Claritas iPET™ comes at a time when Brazil’s healthcare sector is experiencing increasing demand for nuclear medicine imaging services, particularly for the diagnosis and monitoring of oncological, cardiovascular, and neurological diseases. Rising life expectancy, improved disease screening programs, and expanded insurance coverage for advanced diagnostic imaging have contributed to a significant increase in PET-CT scanning volumes nationwide.

Despite growth in imaging infrastructure over the past two decades, the Brazilian healthcare system still faces capacity limitations in nuclear medicine diagnostics, partly due to long scanning durations, high costs of radiopharmaceutical isotopes, and logistical challenges associated with isotope transport and storage. Radiopharmaceutical isotopes used in PET imaging often have short half-lives and strict handling requirements, which can create bottlenecks in clinical workflows and limit the number of patients that can be scanned each day.

Claritas iPET™ addresses these operational challenges by allowing hospitals and imaging centers to process faster scans while maintaining diagnostic image quality, effectively increasing the number of patients that can be examined within the same time frame. By reducing isotope dosage requirements, the technology may also help healthcare providers optimize the use of costly radiopharmaceutical materials while maintaining safety standards.

Improving Diagnostic Accuracy and Clinical Workflow Efficiency

One of the key advantages of Claritas iPET™ is its compatibility with multiple PET imaging systems and radionuclide types, making the software adaptable to a wide range of existing hospital imaging infrastructure. The system is designed to operate independently of specific scanner manufacturers, allowing seamless integration into PET-CT and PET-MRI imaging environments already installed in hospitals and diagnostic centers.

Through advanced image enhancement algorithms and AI-assisted image processing, the platform improves the clarity of diagnostic images generated from accelerated scans. This capability allows physicians to maintain accurate disease detection and clinical decision-making even when imaging acquisition time is significantly reduced. The technology also supports improved clinical workflow efficiency by enabling higher patient throughput while maintaining consistent diagnostic quality.

Brazil currently performs more than 250,000 PET scans annually, and the implementation of Claritas iPET™ could significantly enhance the efficiency of these diagnostic procedures. By enabling faster scanning with lower radiation exposure, the technology may contribute to better patient experiences, improved healthcare accessibility, and more efficient diagnostic imaging services across both public and private healthcare systems.

As global healthcare systems increasingly adopt AI-powered medical imaging technologies, solutions like Claritas iPET™ highlight the growing role of software innovation in transforming diagnostic imaging workflows, helping clinicians deliver more accurate diagnoses, improved patient outcomes, and more efficient healthcare services.

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Source: Claritas press release

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ANVISA approvalClaritas NucMeddiagnostic imaging innovationhealthcare technologymedical imaging softwarenuclear medicine imagingPET CT imagingPET scan technologyradiology software
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