How Agent Astro Delivers ROI
Agent Astro helps regulatory, R&D, and business teams save time, improve accuracy, and make better strategic decisions throughout the 510(k) process. On average, teams recover their monthly subscription cost within the first month by reducing manual research and document review time across key workflows.
ROI Example: Saving just 4 hours per month covers the cost of a Solo subscription.
Tasks
Current State
Using Agent Astro
Value
Predicate & Benchmark Research
Finding and verifying appropriate predicates requires hours of manual searching across FDA databases.
Build predicate tables and lineage trees with links to 510(k) PDFs and classification data.
Save 10–20 hours per project and improve predicate quality.
Tasks
Predicate & Benchmark Research
Current State
Finding and verifying appropriate predicates requires hours of manual searching across FDA databases.
Using Agent Astro
Build predicate tables and lineage trees with links to 510(k) PDFs and classification data.
Value
Save 10–20 hours per project and improve predicate quality.
Guidance & Standards Discovery
Locating relevant FDA guidances and ISO standards requires multiple searches and manual review.
Deep Search retrieves applicable guidances and standards instantly.
Cut research time by 70% and reduce compliance risk.
Tasks
Guidance & Standards Discovery
Current State
Locating relevant FDA guidances and ISO standards requires multiple searches and manual review.
Using Agent Astro
Deep Search retrieves applicable guidances and standards instantly.
Value
Cut research time by 70% and reduce compliance risk.
Verified Research & Cross-Referencing
Cross-checking device data and predicate claims is tedious and error-prone.
Verify claims automatically using FDA and ISO sources.
Reduce rework and ensure traceability for audits and submissions.
Tasks
Verified Research & Cross-Referencing
Current State
Cross-checking device data and predicate claims is tedious and error-prone.
Using Agent Astro
Verify claims automatically using FDA and ISO sources.
Value
Reduce rework and ensure traceability for audits and submissions.
SE Drafting Assistance
Drafting SE comparisons manually is time consuming.
Generate structured tables and first- pass text aligned with FDA phrasing.
Accelerate internal drafting cycles and improve consistency.
Tasks
SE Drafting Assistance
Current State
Drafting SE comparisons manually is time consuming.
Using Agent Astro
Generate structured tables and first- pass text aligned with FDA phrasing.
Value
Accelerate internal drafting cycles and improve consistency.
Tasks
Current State
Using Agent Astro
Value
Early Feasibility Research
Engineers spend days researching existing devices and technologies.
Search FDA summaries and extract key device data and testing methods.
Shorten feasibility research from days to hours.
Tasks
Early Feasibility Research
Current State
Engineers spend days researching existing devices and technologies.
Using Agent Astro
Search FDA summaries and extract key device data and testing methods.
Value
Shorten feasibility research from days to hours.
Clinical Evidence Mapping
Identifying comparable clinical studies requires multiple database searches.
Query FDA submissions and extract relevant study information.
Faster evidence review and better-informed study design.
Tasks
Clinical Evidence Mapping
Current State
Identifying comparable clinical studies requires multiple database searches.
Using Agent Astro
Query FDA submissions and extract relevant study information.
Value
Faster evidence review and better-informed study design.
Risk & Design Comparison
Mapping design features to regulatory requirements is slow because teams must manually compare intended use statements, technological characteristics, and performance summaries across multiple devices.
Astro allows teams to quickly compare these elements across relevant predicates and identify differences that may influence risk, testing scope, or regulatory strategy.
Clearer insight into design implications early in development and improved coordination between engineering and regulatory teams.
Tasks
Risk & Design Comparison
Current State
Mapping design features to regulatory requirements is slow because teams must manually compare intended use statements, technological characteristics, and performance summaries across multiple devices.
Using Agent Astro
Astro allows teams to quickly compare these elements across relevant predicates and identify differences that may influence risk, testing scope, or regulatory strategy.
Value
Clearer insight into design implications early in development and improved coordination between engineering and regulatory teams.
Tasks
Current State
Using Agent Astro
Value
Competitive Landscape Analysis
Tracking competitor devices manually across FDA sources is time intensive.
Deep Search provides structured competitor and predicate data.
Build regulatory intelligence faster and more accurately.
Tasks
Competitive Landscape Analysis
Current State
Tracking competitor devices manually across FDA sources is time intensive.
Using Agent Astro
Deep Search provides structured competitor and predicate data.
Value
Build regulatory intelligence faster and more accurately.
Market Entry Planning
Evaluating clearance trends and review timelines is complex.
Instantly view regulatory pathways and historical clearance data for similar devices.
Make quicker go/no-go and market strategy decisions.
Tasks
Market Entry Planning
Current State
Evaluating clearance trends and review timelines is complex.
Using Agent Astro
Instantly view regulatory pathways and historical clearance data for similar devices.
Value
Make quicker go/no-go and market strategy decisions.
Strategic Communication
Preparing reports for executives or investors requires manual data gathering.
Export FDA-linked tables and summaries directly from Astro.
Produce referenced materials quickly for stakeholder presentations.
Tasks
Strategic Communication
Current State
Preparing reports for executives or investors requires manual data gathering.
Using Agent Astro
Export FDA-linked tables and summaries directly from Astro.
Value
Produce referenced materials quickly for stakeholder presentations.