AI Imaging Software Gets Green Light for Safer, Faster PET Scans in Australia

SYDNEY, Australia – March 06, 2026 – Australian patients and hospitals are set to benefit from a significant advancement in medical imaging technology, as London-based Claritas HealthTech announced it has received approval from Australia's Therapeutic Goods Administration (TGA) to supply its Claritas iPET™ software. This state-of-the-art artificial intelligence tool is designed to dramatically improve the quality of Positron Emission Tomography (PET) scans, enabling diagnostic-level images from scans performed in less time and with lower doses of radiation.

The approval marks a pivotal moment for nuclear medicine in Australia, promising to enhance both patient safety and hospital efficiency. By clearing this software for use, the TGA has opened the door for a technology that addresses some of the most persistent challenges in diagnostic imaging: patient comfort, radiation exposure, and clinical throughput.

A Leap Forward in Diagnostic Clarity

At its core, Claritas iPET™ is an advanced image processing tool that uses sophisticated AI algorithms to refine PET scan data. PET scans are a cornerstone of modern diagnostics, particularly in oncology, neurology, and cardiology, but they can be susceptible to image 'noise'—a form of visual distortion that can obscure fine details. This is especially true when scan times or radioactive tracer doses are reduced.

Claritas iPET™ tackles this problem head-on. The software processes raw scan data to reduce noise and enhance image sharpness, effectively creating a high-quality, diagnostically reliable image from what might otherwise be an unclear scan. According to Claritas, its proprietary methods ensure that crucial diagnostic information, such as the Standardized Uptake Value (SUV) which measures metabolic activity in tumors, is maintained. Critically, the company asserts that the enhancement process does not introduce new artifacts or lose the visibility of fine lesions, which is a primary concern for clinicians.

One of the software's most compelling features is that it is 'equipment agnostic.' This means it can be integrated into a hospital's existing IT infrastructure and used with PET, PET-CT, or PET-MRI scanners from any major manufacturer, such as Siemens Healthineers, GE HealthCare, or Philips. This flexibility removes a significant barrier to adoption, as hospitals are not required to purchase new, costly scanning hardware to benefit from the software's capabilities. It allows healthcare providers to upgrade their imaging quality while maximizing the value of their current capital investments.

Redefining the Patient Experience and Safety

The most immediate and profound impact of Claritas iPET™ will be felt by patients. The standard PET scan procedure can require patients to lie perfectly still for 20 to 40 minutes, a challenging experience for those who are in pain, anxious, or claustrophobic. By enabling clinicians to capture quality images in a fraction of that time, the software promises a much-improved patient experience.

Furthermore, the ability to achieve diagnostic clarity with a reduced dose of the radioactive isotope is a major step forward for patient safety. While the radiation dose from a single PET scan is generally considered safe, minimizing cumulative radiation exposure is a constant goal in medicine. This is particularly important for pediatric patients, who are more sensitive to radiation, and for cancer patients who may require multiple scans over the course of their treatment to monitor progress.

The TGA's approval, which classifies Claritas iPET™ as a Class IIb medical device, indicates that the software has passed a high level of regulatory scrutiny regarding its safety and performance claims. This rigorous evaluation provides assurance to clinicians and patients alike that the technology is both effective and safe for clinical use.

Boosting Efficiency in Australia’s Hospitals

Beyond the direct patient benefits, Claritas iPET™ offers a compelling solution to the operational challenges facing many Australian hospitals and diagnostic imaging centers. Demand for PET scans often outstrips supply, leading to long waitlists that can delay diagnosis and the start of treatment. By significantly reducing the time required for each scan, the software allows for increased patient throughput.

A clinic that can scan more patients each day on the same machine can reduce its backlog, improve patient access to critical diagnostic services, and operate more efficiently. This has significant economic implications, potentially lowering the per-scan cost and improving the financial sustainability of nuclear medicine departments.

The real-world impact of this efficiency gain has already been observed in other markets. Dr. Fernando Salis, a practicing nuclear medicine physician and director of Claritas NucMed Brazil, commented on its implementation there. “We are extremely pleased to see the response and demand in Brazil where hospitals have implemented Claritas iPET™ to improve the quality and efficiency of PET scans increasing the number of patients scanned per day, improving patient access and reducing cost,” he stated in the company's announcement.

Navigating a Rigorous Regulatory Landscape

Securing TGA approval is a significant milestone for Claritas HealthTech and a testament to the robustness of its technology. The Class IIb classification places it in a category of moderate-to-high risk devices, meaning the company had to provide substantial evidence to Australian regulators that the software performs as intended and is clinically safe. This approval not only grants Claritas access to the Australian market but also strengthens its credibility on the global stage as it pursues expansion in other highly regulated healthcare systems.

The introduction of Claritas iPET™ into the Australian market represents a convergence of several critical healthcare trends: the drive for operational efficiency, the prioritization of patient-centric care, and the powerful integration of artificial intelligence into clinical workflows. As hospitals and clinics across the country begin to evaluate and adopt this technology, its true impact on diagnostic pathways and patient outcomes will become clearer, potentially setting a new benchmark for the quality and accessibility of nuclear medicine. The approval marks a significant step, not just for the company, but for the ongoing digital transformation of healthcare in Australia.