Claritas NucMed Receives Clearance from Brazilian Regulator ANVISA to Market Claritas iPET™ Software Enabling Reduced Scan Time and Reduced Isotope Dosage in PET-CT/MRI Scans
NEW YORK and LONDON and SAO PAOLO, Oct. 29, 2024 (GLOBE NEWSWIRE) — Claritas NucMed Tech Brazil S.A. (“Claritas NucMed Brazil”), a subsidiary of UK-based Claritas NucMed Technologies Ltd (“Claritas NucMed”), a company specializing in image processing and quantification for the nuclear medicine imaging industry, is pleased to announce that it has secured regulatory clearance from the Brazilian National Health Surveillance Agency, ANVISA (Agência Nacional de Vigilância Sanitária) to market Claritas iPET™ in Brazil.
Claritas iPET™ will be distributed by New Vida Medicamentos e Productos Ltda., a wholly owned subsidiary of Claritas NucMed Brazil, and an approved distributor of medical devices in Brazil.
Claritas iPET™, cleared in several jurisdictions, including by the US FDA, is a software medical device that enables accelerated and significantly reduced isotope PET scans while yielding diagnostic quality images.
Dr Fernando Salis, a practicing nuclear medicine physician and CEO of, Claritas NucMed Tech Brazil, commented, “This marks a significant milestone for Claritas NucMed. The deployment of Claritas iPET™ can immediately provide tangible benefits to patients offering shorter acquisition time and less radiation exposure per procedure. For physicians, better image quality can help them provide more accurate diagnosis and for payors and sponsors who pay for such expensive procedures, this solution provides an opportunity for significant cost reduction.”
Increasing life expectancy coupled with rising incidence and tracking of different types of cancers in Brazil, and the recently decreed policy for coverage of such diagnostic scans by both government and private insurance sectors, have contributed to the huge growth in demand for nuclear medicine imaging in Brazil. Despite the substantial growth over the last two decades in terms of both number of equipment and number of PET-CT scans in the country, there are substantial shortages with demand outstripping supply due to the long scanning time and the challenges associated with isotopes such as high cost, short life and transportation issues.
Dr Fernando Salis added, “We have been working with clinicians in Brazil anticipating the clearance and approvals of Claritas iPET™ for the Brazil market, and will be deploying the platform nationwide, both in the private and public healthcare sectors. With over 250,000 PET scans a year in Brazil, our aim is to assist the clinicians with diagnostic accuracy and workflow improvement and to help improve patient care and experience.”
Claritas iPET™ is agnostic to equipment brand/manufacturer and works with all types of radionuclides and can be easily integrated into existing systems. Hospitals and imaging centres can enhance images from accelerated scans increasing scan throughput, with reduced isotope dosage, while providing a much-improved patient experience, by reducing radiation exposure and scan time.
About
Claritas NucMed Technologies Ltd, a subsidiary of Claritas HealthTech Ltd, is based in London, United Kingdom, and is the authorised distributor of Claritas iPET™, iPETcertum™, iSPECTcardiac™, and other nuclear medicine devices globally.
Claritas HealthTech Ltd conducts research and development in the fields of image enhancement, machine vision and artificial intelligence (“AI”) with a focus on medical image processing and AI assisted interpretation and diagnostics. Claritas aims to transform the diagnostics industry with powerful and effective software products created using image enhancement and AI technology enabling and assisting doctors and physicians to make accurate diagnosis and improve patient lives.
Claritas NucMed Tech Brazil S/A a subsidiary of Claritas NucMed Technologies Ltd, is based in Sao Paolo, Brazil.
For more information, please visit www.claritashealthtech.com
For Enquiries, please contact:
Devika Dutt, COO
Claritas HealthTech Ltd