AetherAI and Paige win approvals
- AetherAI’s aetherSlide and Tempus-owned Paige Prostate are advancing in regulated digital pathology, with aetherSlide cleared by FDA and Paige expanding in Europe. - Paige says its prostate software cut cancer detection errors by 70% for 16 first-time users; FDA first authorized Paige Prostate in 2021. - The approvals widen clinical use of AI pathology tools as labs digitize slide review and reporting workflows. (tempus.com)
Pathology is the lab specialty that turns tissue samples into diagnoses, and digital pathology turns glass slides into giant image files pathologists can review on screens. AetherAI and Tempus-owned Paige are now using regulatory clearances to push that shift deeper into routine care. (aetherai.com) (tempus.com) AetherAI’s core product is aetherSlide, a digital pathology image viewer and management system. The U.S. Food and Drug Administration lists aetherSlide under 510(k) number K233126, with a substantial-equivalence decision dated May 30, 2024. (fda.gov) AetherAI says aetherSlide is FDA-cleared, Taiwan Food and Drug Administration-approved, and CE-marked, and that the platform is built to plug in third-party or in-house artificial-intelligence apps. Its product pages describe uses including slide quality control, case triage, lesion detection, differential cell counting, and immunohistochemistry quantification. (aetherai.com 1) (aetherai.com 2) Paige’s flagship prostate product works differently: it is not the slide viewer itself, but software that flags suspicious areas on scanned prostate biopsy images after a pathologist’s initial review. The Food and Drug Administration granted Paige Prostate a De Novo authorization on September 21, 2021, creating a new Class II device category for software that assists users in digital pathology. (fda.gov 1) (fda.gov 2) Tempus said on April 14, 2026 that Paige Prostate received European Union In Vitro Diagnostic Regulation certification in 2025. Tempus said the certified suite includes Paige Prostate Detect, Paige Prostate Grade & Quantify, and Paige Prostate Perineural Invasion. (tempus.com) The companies are selling a similar promise to hospitals: fewer manual steps and faster review of huge whole-slide images. AetherAI says its workflow system helps pathologists monitor workload and prioritize cases, while Tempus says Paige Prostate improved sensitivity from 88.7% to 96.6% and cut detection errors by 70% in a cohort of 16 first-time users. (aetherai.com) (tempus.com) That does not mean the software replaces the doctor. The Food and Drug Administration’s authorization for Paige describes it as an adjunct to standard review, and AetherAI markets aetherSlide as infrastructure for image management and integrated tools rather than an autonomous diagnostic system. (fda.gov) (aetherai.com) AetherAI has been building around the platform with automation hardware and hospital deployments. The company said in 2025 that it launched a fully automated pathology slide scanning system with Techman Robot and Hamamatsu Photonics, and its corporate timeline says aetherSlide is used at major medical centers in Taiwan and at RWTH Aachen University Hospital in Germany. (aetherai.com 1) (aetherai.com 2) Tempus, meanwhile, bought Paige for $81.25 million in 2025, adding Paige’s pathology software and data assets to its broader diagnostics business. The regulatory story now is less about a single approval than about who can turn cleared software into routine lab workflow across the United States and Europe. (medtechdive.com) (fiercebiotech.com)
