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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears DeepHealth's Prostate AI Software for Prostate MRI Reading

The RadNet subsidiary's tool combines lesion detection, gland segmentation and PI-RADS reporting, and also won a CE mark, announced alongside three other European certifications.

By News DeskMay 21, 20262 min read
Orange 3D rendering of a prostate with a red target lesion and numbered biopsy core tracks
A 3D prostate model from an MRI-ultrasound fusion biopsy showing a target region and biopsy cores. Not DeepHealth software. Jessedle, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA cleared510(k)FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • DeepHealth announced on May 19 that its Prostate AI software received FDA 510(k) clearance and a CE mark.
  • The software combines lesion detection, risk classification, gland segmentation, PSA density calculation and PI-RADS reporting.
  • DeepHealth says its portfolio now stands at 27 FDA-cleared and 26 CE-marked technologies.

DeepHealth, the AI subsidiary of imaging center operator RadNet, said on May 19 that its Prostate AI software for prostate MRI has received 510(k) clearance from the U.S. Food and Drug Administration and a CE mark in Europe, as reported by Diagnostic Imaging and Deployed, a publication of AIM Media House.

Prostate AI is part of DeepHealth's Prostate Suite. According to the company, it combines lesion detection, risk classification, gland segmentation, prostate-specific antigen (PSA) density calculation and PI-RADS-compliant reporting in one workflow, and is compatible with 11 fusion biopsy systems. Neither report gave a 510(k) number.

Company-reported performance

DeepHealth said real-world use of Prostate AI found 27% more lesions, reduced variability in gland segmentation between radiologists by 65% and cut workflow time by 37% in cases where biopsy was recommended. The company did not release the underlying study details; the figures are its own.

Francesco Giganti, an associate professor of radiology at University College London, was quoted in the announcement: "One of AI's most significant contributions in prostate cancer detection is expanding access to prostate screening." Deployed reported that the CE-marked Prostate Suite is being used in the UK's TRANSFORM prostate screening trial, which Prostate Cancer UK expects to analyse more than 100,000 scans.

European approvals in the same announcement

The announcement also covered CE marks for three other products, Deployed reported. Brain Health and Brain Age, part of DeepHealth's Neuro Suite, were already FDA-cleared and are being deployed across RadNet's outpatient imaging centers in the US. Brain Health detects and segments white matter hyperintensities on FLAIR MRI scans, and Brain Age analyses hippocampal, lobar and subcortical regions for dementia and memory evaluations; the company said Brain Age showed 92% sensitivity in identifying hippocampal atrophy associated with Alzheimer's disease.

The third CE mark went to LumbarMR, an AI system for lumbar spine MRI interpretation that came to DeepHealth through RadNet's acquisition of French radiology AI company Gleamer earlier this year. DeepHealth said LumbarMR reduced reporting time by 17% per exam compared with residents working without AI, with up to 94% sensitivity.

"At DeepHealth, we believe we are delivering the world's most comprehensive portfolio of native clinical AI solutions and services in radiology," said Niccolo Stefani, business and product leader for population health and clinical AI, in the announcement.

With these approvals, DeepHealth said its portfolio stands at 27 FDA-cleared and 26 CE-marked technologies.

Sources

  1. FDA Clears Emerging AI Software Application for Prostate MRI, Diagnostic Imaging, May 20, 2026
  2. DeepHealth Expands Clinical AI Portfolio With New FDA and CE Clearances, Deployed (AIM Media House), May 21, 2026