AISight Dx analyzes digital pathology slide images to assist diagnosis
FDA 510(k) clearance for primary diagnosis in clinical settings, June 2025
Predetermined Change Control Plan allows faster future software updates
Expanded Labcorp collaboration deploying nationwide as of February 2026
FDA Breakthrough Device Designation for PathAssist Derm dermatopathology tool
Pros
Broad, single-workflow FDA clearance covers many conditions rather than just one
Strong published clinical accuracy figures from the FDA pivotal study itself
Massive global hospital deployment gives extensive real-world validation
Genuine FDA clearance for primary diagnosis, not just an assistive tool
Predetermined Change Control Plan speeds up future regulatory-approved updates
National-scale deployment through Labcorp validates real clinical trust
Cons
Enterprise pricing requires a sales conversation, no published self-serve rate
Built specifically for radiology triage, not a general clinical documentation tool
Requires integration with a hospital's existing imaging infrastructure to deploy
Enterprise quote-based pricing requires a sales conversation, no published rates
Built specifically for pathology labs, not applicable to other clinical specialties
Regulatory-cleared medical device status means slower iteration than software-only tools
Company
Aidoc, founded 2016
PathAI, founded 2016
Prices come from each vendor's pricing page, last checked 20260715. Check the vendor before you buy.
FAQ
Questions people ask
Is Aidoc better than PathAI?
In our reviews Aidoc scores 4.4 and PathAI scores 4.3. The better pick depends on the job. Aidoc: FDA-cleared triage AI hitting 97% sensitivity, deployed in nearly 2,000 hospitals. PathAI: First AI pathology platform FDA-cleared for primary diagnosis, now deployed nationwide via Labcorp.