Lexim

Lexim AI (Lexim Sphere) — Two joined assets: (1) a normalized FDA medical-device corpus — 510(k) clearances, PMAs, MAUDE adverse-event reports, recalls and product classifications aggregated into one searchable universe; (2) a continuously-tracked global regulatory library across 15+ countries where every document carries an automated six-layer analysis and a full lifecycle trail from draft to amendment. Micro-scale startup (~17 employees, Cupertino) with maximal claimed coverage: the entire FDA device universe plus a 15+ country regulatory library, each document carrying six layers of derive…

Lexim offers (Regulatory, Alternative, Reference) — The complete FDA device dataset (510(k), PMA, MAUDE, recalls, classifications — MAUDE alone exceeds 100M cumulative reports and 510(k) clearances run to six figures) plus every regulatory document from 15+ national authorities, each with a retained version history and six-layer derived analysis.

Medtech competitive intelligence (clearance velocity, recall and adverse-event clustering by manufacturer); regulatory-change alpha for device equities; compliance-gap training data for legal/regulatory LLMs; paired regulation-text corpora across 15+ jurisdictions for cross-lingual alignment and document-diff model training; adverse-event risk scoring by device class

The data is with 30 years of history.

Coverage spans US, Europe, Other, Japan; Health Care Equipment, Application Software; regulatory, alternative, reference; equities.