Health Diagnostics

Kheiron’s AI Breast Screening Solution Receives Regulatory Clearance

Brought to Australia and New Zealand in Partnership with AI Advance, Mia is the First and Only AI-Enabled Independent Reader for Breast Cancer Screening to Receive Clearance in Each Country

Marking a new milestone for artificial intelligence (AI) adoption in the Australian and New Zealand breast screening community, the Mia® solution, created by United Kingdom-based Kheiron Medical Technologies, received Therapeutic Goods Administration (TGA) clearance from the Australian Government Department of Health and MedSafe WAND Notification from the New Zealand Ministry of Health as an AI-enabled independent reader for the early detection and diagnosis of breast cancer. Mia is being launched in partnership with AI Advance, an AI consulting services and software distribution company for the medical imaging industry based in Australia and New Zealand.

“Our mission at Kheiron is to support breast screening professionals in the fight against breast cancer with proven and effective AI-enabled tools,” states Alex Hamlow, Kheiron’s chief commercial officer. “We’re excited that Mia is the first AI independent reader solution available for use within the breast screening community in Australia and New Zealand. Based on its performance in the UK and Europe, Mia represents a major breakthrough in helping radiologists to dramatically improve breast cancer detection and patient outcomes.”

With patented AI technology developed on more than three million breast images, Mia (Mammography Intelligent Assessment) is designed to support breast radiologists in making the decision about whether or not to recall women for further testing based on their mammography screening. It was created to deliver gold standard double-reading quality with a single human reader and can also function as an independent second reader, a concurrent reader, or in double reader triage.

“We are looking forward to bringing the Mia solution to the breast screening community throughout Australia and New Zealand,” comments Peter Rady, director and co-founder of AI Advance. “It has tremendous potential to transform the breast screening pathway by empowering breast screening professionals to detect potential malignancies more accurately and quickly, ultimately saving more lives in the fight against breast cancer.”

Mia’s effectiveness has been proven in one of the most ambitious clinical studies in radiology AI to date and tested across multiple demographics and mammography devices. It was one of the recipients of the UK Government’s first AI in Health and Care Awards through which Mia is undergoing multiple deployments and clinical studies across 15 sites in the UK as a benchmark for how to integrate new, cutting edge technologies into the NHS safely and effectively. Kheiron and AI Advance are currently working with an Australian breast-screening provider to establish the protocols for a forthcoming clinical trial, details of which will soon be announced.

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