Imaging: reports and image quality: what the evidence shows
Software that drafts radiology report impressions, removes noise from MRI scans so protocols can run faster, or outlines and scores suspicious lesions on prostate MRI for the radiologist.
Deep learning tools that clean up MRI images were cleared through 510(k): SubtleMR as radiological image processing software and AIR Recon DL as a reconstruction feature of GE's MRI systems, on image quality tests and reader studies of image appearance. Published studies are mostly small reader studies in which radiologists rated faster, processed scans as equal or better, such as a 61-patient spine study with 40% shorter scans. Independent work has found limits: one study found brain lesions under 4 mm missed on half-time processed scans, and another found that reconstruction shifted brain volume measurements. No study found here measured scanner throughput, repeat scans or patient outcomes.
No FDA clearance was found for the impression drafting tool reviewed here; the one vendor study found, a retrospective rating of 200 CT reports, did not measure reporting time or editing. Prostate MRI detection software is cleared on reader studies such as the 247-case study behind DeepHealth ProstateAI.
The tools reviewed in this category
General information, not medical advice. Every fact links to its source, and the page shows the date it was last reviewed.