Claritas HealthTech Receives Clearance from Indian Regulator CDSCO for Claritas iPET™ Software in India for Improving Quality and Efficiency of PET-CT & PET-MRI Scans
/EIN News/ -- BENGALURU, India and LONDON, July 15, 2024 (GLOBE NEWSWIRE) -- Claritas HealthTech Ltd (“Claritas”), a healthcare technology company specializing in advanced medical image enhancement, reconstruction, and AI solutions for the medical industry, is pleased to announce today, that it has received clearance from the Central Drugs Standard Control Organisation (CDSCO), the Indian regulatory authority for medical devices, to import and market Claritas iPET™ in India.
Claritas iPET™, an FDA 501(k) cleared medical device for accelerated and reduced isotope scans, is an image processing software that implements a powerful algorithm-based solution to enhance the quality of PET and SPECT scans by denoising, sharpening organ boundaries and achieving super-resolution. PET and SPECT scans can be further improved to provide additional details by using an overlay of an MRI or CT image of the same region. The Claritas iPET™ enhancement capability is significant as it can be used for reducing scan times and reducing isotope dosage required while yielding diagnostic quality images.
Demand for nuclear medicine in India is growing at an exponential rate. The number PET-CT scanners has doubled in last five years and expected demand is another 1000 scanners over the next decade (Indian Journal of Nuclear Medicine38(3):201-207, Jul-Sep 2023). Prevalence and tracking of increasing types of cancers in India have led to the increase in need in PET imaging and isotopes. India has been ramping up its workforce and infrastructure to meet the rapidly increasing demands for nuclear medicine imaging, where despite its growth, demand outstrips supply. PET imaging has helped not only in improving patients’ outcomes both in terms of overall survival and progression-free survival but also in improving the quality of life, social economic health as well as an early cancer detection in India.
Claritas iPET™ 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 and profitability, while providing a much-improved patient experience.
Nischay Saraf, MD of Claritas HealthTech India Pvt Ltd commented, “We have been working with clinicians anticipating the clearance and approvals of Claritas iPET™ for the Indian market, and will be deploying the platform nationwide, both in the private and public healthcare sectors. With over 500,000 PET scans a year in India, our aim is to assist the clinicians with diagnostic accuracy and workflow improvement”
Claritas iPET™ is agnostic to manufacturer type/equipment brand and can be deployed and integrated onsite or easily accessed via the cloud.
Chetan Baxi, MD of Claritas HealthTech Ltd UK added, “Being able to bring Claritas iPET™ to market in India marks a significant milestone for us. Along with China and Brazil where we are awaiting our regulatory clearances, India has been a top priority for us. We have seen a very strong demand for our solutions in India, as such, we will continue to add several product and service offerings by Q4 2024.”
About Claritas HealthTech
Claritas 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. All Claritas products are compliant with HIPPA, DPDPA and GDPR requirements.
Claritas HealthTech India Pvt Limited, a subsidiary of Claritas HealthTech Ltd, is based in Bengaluru, India and is the authorised importer and distributor of Claritas iPET™ in India.
For more information, please visit www.claritashealthtech.com
For Enquiries, please contact:
Devika Dutt
Claritas HealthTech Ltd
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