Abkus Academic combines systematic literature review, regulatory classification, and technology transfer into one AI-powered platform. Built for researchers at US, European, and Latin American institutions who want to see their innovation reach patients.
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The same platform, adapted to FDA, EMA, and ANVISA workflows.
FDA 510(k) — Class II
CE Mark · MDR Class IIb
ANVISA Class III · RDC 751/2022
Six integrated modules covering the full lifecycle of health product research.
Run PRISMA, SPIDER, and scoping reviews with 6 sequential AI agents. Triages 50+ abstracts, extracts data, evaluates quality (RoB 2 + GRADE), and generates the full report.
Learn more →Monitors NIH (R01, R21, SBIR/STTR), NSF, DARPA, Gates Foundation, Wellcome Trust, ERC, Horizon Europe, CNPq, and FAPESP. Scores compatibility (0–100%) and drafts the proposal.
Learn more →Wizard-guided product classification for FDA (510k, PMA, De Novo), EMA (MDR/IVDR), and ANVISA. Returns the risk class, predicate devices, applicable standards, and full ISO matrix.
Learn more →AI-structured submission files for FDA 510(k)/PMA, EMA Technical File (MDR Annex II), and ANVISA. Each section includes templates, legal references, and compliance checklists.
Learn more →Tracks FDA (Federal Register), EMA (EUDAMED), and ANVISA (DOU) publications daily. Notifies you when a new rule impacts your submission sections — scored 0–100 for urgency.
Learn more →Patent strategy for USPTO, EPO, and INPI. Partner mapping (CROs, CMOs, distributors) across North America, Europe, and Latin America. Go-to-market analysis for each region.
Learn more →Stay ahead of every grant cycle across North America, Europe, and Latin America.
From product approval to clinical trial ethics — all four major health research systems.
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