aetherAI vs Tempus Digital Pathology

aetherAI fits hospital labs that run the Philips Ultra Fast Scanner and the Philips PS27QHDCR monitor. Its single FDA record, K233126 from May 2024, covers the aetherSlide viewer for primary diagnosis of FFPE surgical pathology slides on that hardware only. The vendor lists bone marrow and colon polyp modules with Taiwan TFDA approval.

Tempus suits a hospital lab that wants Paige's FDA-authorized prostate tool beside its own viewer, and its page says Prostate Detect must be used with specific scanners and viewers. The line holds two FullFocus viewer 510(k)s, K201005 from July 2020 and K241273 from January 2025, plus Paige Prostate Detect, a De Novo authorization (DEN200080, September 2021) with CE-IVDR marking and a vendor-claimed 20% shorter reading time. aetherAI is the weaker buy for a hospital lab that wants an FDA-authorized AI tool beside its viewer, since the K233126 indication carries no AI claim. Paige Predict and the Breast, Lymph Node, GI and PanCancer Detect tools are labeled research use only.