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
15 Julio 2024 - 12:31PM
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
d.d@claritasco.com