Harrison.ai

Which products does Harrison.ai sell?

There are three. Harrison.ai CT Brain reads non-contrast head CT and reports "up to 130 findings in under 90 seconds." Harrison.ai Chest X-ray reports "up to 124 findings in under 20 seconds." Harrison.ai CT Chest reports "up to 167 radiological features." Listed uses are emergency and acute care, public and private hospitals, oncology, teleradiology and incidental detection.

On integration, Harrison's pages describe PACS and RIS connections. A document released by Australia's TGA describes an integration adapter that returns a DICOM Secondary Capture to the PACS or posts to a RIS worklist. The Royal College of Radiologists' registry lists NHS deployments on Sectra and Philips PACS, with CE marking at MDR class IIb and FDA at class II.

Harrison.ai also says its radiology foundation model is open for research use at chat.harrison.ai, and that 3,500 clinicians at more than 1,000 sites on four continents use its tools as assistive software.

Who is the company now?

Harrison.ai is a private company in Sydney, founded in 2018 by Dr Aengus Tran and Dimitry Tran, with a North American headquarters in Boston being set up as of February 2025. The brand was a 2020 joint venture with the I-MED Radiology Network, and the two companies combined in April 2024. A pathology arm operates as Franklin.ai.

The Series C in February 2025 raised US$112M (A$179M), led by Aware Super, ECP and Horizons Ventures. Total outside funding is above US$240M.

What has FDA cleared?

FDA's 510(k) records show nine clearances. Eight are under the earlier applicant name and one is under Harrison-AI Medical Pty, Ltd.

• K213941, February 2022, chest X-ray triage for pneumothorax
• K222268 and K222179, March 2023, chest X-ray triage for trauma
• K223240, April 2023, head CT triage for trauma
• K231094, August 2023, head CT triage, labelled Triage-OH
• K231767 and K231384, September 2023, head CT triage for trauma
• K250831, April 2025, the Enterprise platform (product code QFM)
• K253818, March 2026, the Enterprise platform, filed by Harrison-AI Medical Pty, Ltd.

Press coverage speaks of 12 FDA clearances, an FDA Breakthrough designation and NTAP (new technology add-on payment) status for a CT Brain algorithm. FDA's records list three chest X-ray triage clearances, four head CT triage clearances and two Enterprise platform clearances, nine in all.

What do independent evaluations show?

Maiter and colleagues compared Harrison's chest X-ray product, version 3.8, with six other devices for lung cancer detection in Radiology, on 5,235 patients. All the devices produced more false positives than the radiologist reports did. Diagnostic Imaging covered a separate study that raised doubts about sensitivity for smaller and multiple chest X-ray findings. Small pneumothorax and effusion were the weak spots.

The Scottish Health Technologies Group summary of the NHS Grampian evaluation reports specificity of 91%, negative predictive value of 99.99%, sensitivity of 78% and positive predictive value of 3%, so most flagged studies in that population were false alarms. Harrison's position, as reported by Austrade, is that diverse training data keeps false positives down.

How is it sold?

Buyers are sent to a demo booking, with no price on the site. Its pages cite 45+ NHS trusts and Hong Kong emergency departments as users.

The verdict

The chest X-ray tool has the most outside testing, and the testing is mixed: strong negative predictive value, modest sensitivity and a heavy false-positive load. A department where a missed pneumothorax is the main worry may accept that trade, and one that must clear a large volume of normal films will feel the 3% PPV in every shift. The head CT triage clearances are older and cover trauma triage plus the one Triage-OH listing.