Agent skill

Fda Catalyst Devices

by agentii-ai in agentii-ai/agentii-investment-intelligence

Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations —…

Apache-2.0Auto-check passedProduct & Project Management

Install Fda Catalyst Devices

skills CLI
$ npx skills add agentii-ai/agentii-investment-intelligence --skill fda-catalyst-devices -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install agentii-ai/agentii-investment-intelligence fda-catalyst-devices --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/agentii-ai/agentii-investment-intelligence.git skills-src && mkdir -p .claude/skills && cp -r skills-src/plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-devices .claude/skills/fda-catalyst-devices && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
fda-catalyst-devices
GitHub stars
207
Token cost
~1.9k tokens
SKILL.md length
720 words
Files
3 (incl. references)
Skills in repo
79
Repo updated
First seen
Licence
Apache-2.0

At a glance

Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations —…

  • Works in 4 steps: Structured decision data:… → Filing context: search_documents /… → Coverage and NTAP milestones:… → …
  • Tasks that involve Project management
  • SKILL.md covers Defaults, Preflight, Triggers and Production Grounding, plus 11 more sections
  • Instructions only: no scripts, shell commands, URLs or credentials in SKILL.md

What it does

Fda Catalyst Devices is an agent skill from agentii-ai/agentii-investment-intelligence. Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations — dated, verified, and sized per event for any medtech ticker or watchlist.

Its SKILL.md is about 1.9k tokens, which your agent loads only when the skill is triggered. The skill folder holds 3 other files, including reference files (for example `references/knowledge-frameworks.md` and `references/modes.md`).

It sits in Product & Project Management, covering Project management. The repository describes itself as: Claude-type skills for institutional equity research — 25 AI agent skills with SEC filings, XBRL financials, earnings calendars, DCF/comps/LBO models, and PPT generation. Powered… The licence is Apache-2.0.

When your agent uses it

  • Tasks that involve Project management

Example prompts

  • “/fda-catalyst-devices”

Workflow steps

4 steps, taken from the first numbered list in SKILL.md.

  1. Structured decision data: get_device_decision (device_decision_event); asset identity via search_universe_devices / get_company_devices.
  2. Filing context: search_documents / search_sec_filings for PMA submissions, recall disclosures, MDRs.
  3. Coverage and NTAP milestones: search_documents keyword coverage/NTAP + read_source_outline/read_source_pages.
  4. Historical grounding: search_investment_cases (device decision/recall events), search_by_analogue.

What it can do on your machine

Read from SKILL.md and the folder at commit 86980e1. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    No scripts in the folder and no shell commands in SKILL.md.

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Fda Catalyst Devices loads about 1.9k tokens when it runs, and up to ~3.1k if it reads all its reference files. Until then it costs about 72 tokens; SKILL.md has 720 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~72
When it runs · the whole SKILL.md, loaded when a task matches
~1.9k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~3.1k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); files beside SKILL.md are not scanned.

SKILL.md

The full file from agentii-ai/agentii-investment-intelligence at commit 86980e1, republished under its Apache-2.0 licence (© agentii-ai). 720 words, ~1,884 tokens.

Download SKILL.mdSave it as .claude/skills/fda-catalyst-devices/SKILL.md (or your agent's skills folder). This skill also uses 2 other files; get the full folder from GitHub.
name
fda-catalyst-devices
description
Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations — dated, verified, and sized per event for any medtech ticker or watchlist.
sectors
med.medicines_biotech, med.medical_devices
multi_ticker_semantics
basket_v1_1
temporal_scope.default_quarters
4
temporal_scope.max_quarters
8
temporal_scope.description
Forward catalyst window default 4 quarters; up to 8 for long-horizon coverage and surveillance mapping.
retrieval_scope
unstructured_document_search
min_tool_diversity
3
parameter_free
false

Methodology inspired by publicly taught medtech catalyst frameworks; all text is an original paraphrase.

Defaults

ParameterDefault ValueRationale
forward_window_quarters4Standard catalyst window; extend to 8 on request
include_supersededfalseActive-only events by default; supersede chains on request
coverage_lenstrueCoverage and NTAP milestones tracked alongside decision events
recall_scantrueRecalls and watch actions surfaced as risk signals by default
holiday_labelingtrueHoliday-shifted weeks flagged on every calendar row

Preflight

Run canonical pre-flight per contracts/preflight.md. Include the X-Agentii-Trace header on every tool call per contracts/x-agentii-trace-header.md — carry the _run_id from your first tool result and name yourself (and your parent, if you were spawned). Confirm ticker resolution via search_companies before catalyst queries.

Triggers

  • "What device decisions (510(k)/PMA/De Novo) are coming up for [ticker]?"
  • "When is the PMA decision date for [device/ticker]?"
  • "Which medtech names have device decisions this quarter?"
  • "What coverage or NTAP milestones are pending for [ticker]?"
  • "Has [ticker] had any recalls or watch-list actions recently?"
  • "Build a device catalyst calendar for my medtech watchlist."
  • "How do De Novo classifications differ from 510(k) as catalysts?"
  • "Evaluate the approval odds for [device] ahead of its panel."
  • "What post-market surveillance obligations does [ticker] carry?"
  • "Which device decisions overlap with [ticker]'s earnings date?"
  • "How did similar devices trade around their decision dates?"
  • "What is the installed-base story behind [ticker]'s next label expansion?"

Production Grounding

  • Device decision tracks: 510(k) clearance (substantial equivalence), PMA approval (higher evidence bar), De Novo classification (novel low-to-moderate-risk path) — each carries a binary-event dynamic.
  • Reimbursement is the second gate: CMS coverage determinations and NTAP milestones convert an approval into revenue; an approval without a coverage path is a hollow catalyst.
  • Recall and watch actions invert the signal: recall classes, watch lists, and post-market surveillance findings are negative catalysts that can compound.
  • Device vocabulary: installed base, placements, procedures, utilization, ASP with label-expansion annotations — the commercial context for sizing the post-decision move.
  • Never fabricate decision dates, recall classes, or coverage outcomes; annotate coverage gaps (per references/knowledge-frameworks.md).

Data Source Priority

  1. Structured decision data: get_device_decision (device_decision_event); asset identity via search_universe_devices / get_company_devices.
  2. Filing context: search_documents / search_sec_filings for PMA submissions, recall disclosures, MDRs.
  3. Coverage and NTAP milestones: search_documents keyword coverage/NTAP + read_source_outline/read_source_pages.
  4. Historical grounding: search_investment_cases (device decision/recall events), search_by_analogue.

Methodology

Retrieval Scope

unstructured_document_search

Retrieval Strategy
  1. Resolve ticker(s) via search_companies; collect company_id for device queries.
  2. Pull active decision events (get_device_decision) and asset inventory (get_company_devices).
  3. Overlay coverage/NTAP milestones and recall/watch actions from filings.
  4. For panel meetings, retrieve briefing documents via read_source_outline/read_source_pages; apply scrutiny axes.
  5. Ground the play: search_investment_cases / search_by_analogue with device filters; cite /v/ records.
Show full SKILL.md (294 more words)Show less
Temporal Scope

See frontmatter temporal_scope block. Post-market surveillance windows may require looking back up to 8 quarters.

Tool Allowlist

See frontmatter allowed_tools.

Protocol
  1. Ticker resolution
  2. Decision enumeration (510(k) / PMA / De Novo)
  3. Coverage and NTAP milestone overlay
  4. Recall and watch risk scan
  5. Analogue grounding + calendar synthesis

Modes

  • Watchlist (default, multi-ticker): one dated calendar with per-ticker sections, sorted by date.
  • Single ticker deep-dive: full decision timeline, coverage state, and recall history.
  • Event type: restrict to PMA / De Novo / 510(k) / coverage / recalls on request.
  • Risk scan: recall and watch actions as a forward-looking risk screen.

Tool Fallbacks

FailureFallback
get_device_decision emptysearch_documents keyword decision/PMA + search_sec_filings; annotate coverage_gap
Coverage milestone not foundFlag reimbursement status unknown; never assume a coverage path
Recall data missingState surveillance data unavailable; do not infer recall classes
Knowledge tools emptyProceed with structured data only; annotate knowledge coverage_gap

Output File

{ticker}/{YYYY-MM-DD_HHMM}_fda-catalyst-devices_{affix}.md (watchlist: watchlist/{YYYY-MM-DD_HHMM}_fda-catalyst-devices-calendar_{affix}.md)

Output Structure

  1. Executive Summary — highest-impact device-track catalysts in the window, 2-3 sentences
  2. Catalyst Calendar — dated table: date, ticker, event type, device, application, holiday-week flag, expected-impact framing
  3. Per-Event Analysis — decision-track assessment (evidence bar, scrutiny axes) + decision history
  4. Coverage & Reimbursement State — coverage determinations, NTAP milestones, ASP context
  5. Recall & Surveillance Scan — recall classes, watch actions, post-market obligations
  6. Risk Assessment & Coverage Gaps — binary-risk sizing, signal clusters, missing data

Error Handling

ErrorFallback
No device decision rowsFall back to earnings + pipeline events; annotate coverage_gap — never fabricate dates
510(k) vs PMA ambiguityState both possibilities with the evidence-bar difference; do not guess the track
Ticker not in med universeResolve via CIK/device-universe match; surface the classification gap

Memory Load

See contracts/memory-load.md.

Snapshot

See contracts/snapshot-synthesis.md.

Final Summary (TUI)

Include ### Key Citations block with 0-10 clickable /v/ URLs.

References

  • contracts/citation-and-memory.md
  • contracts/output-frontmatter-schema.md
  • contracts/memory-load.md
  • contracts/snapshot-synthesis.md
  • contracts/preflight.md
  • references/knowledge-frameworks.md

© agentii-ai, Apache-2.0. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 2 other files (references) in plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-devices of agentii-ai/agentii-investment-intelligence.

  • SKILL.md
  • references/knowledge-frameworks.md
  • references/modes.md

Open the folder on GitHubat commit 86980e1

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Questions about Fda Catalyst Devices

What does Fda Catalyst Devices do?

Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations —…. Fda Catalyst Devices is an agent skill from agentii-ai/agentii-investment-intelligence. Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations — dated, verified, and sized per event for any medtech ticker or watchlist.

When should I use Fda Catalyst Devices?

Fda Catalyst Devices fits situations like: tasks that involve Project management.

How do I install Fda Catalyst Devices in Claude Code?

Run `npx skills add agentii-ai/agentii-investment-intelligence --skill fda-catalyst-devices -a claude-code`. Or copy the skill folder (plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-devices in agentii-ai/agentii-investment-intelligence) into .claude/skills/fda-catalyst-devices in your project. Claude Code loads it when a task matches its description.

How do I install Fda Catalyst Devices in Codex?

Run `npx skills add agentii-ai/agentii-investment-intelligence --skill fda-catalyst-devices -a codex`. Or copy the skill folder (plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-devices in agentii-ai/agentii-investment-intelligence) into .agents/skills/fda-catalyst-devices in your project. Codex loads it when a task matches its description.

Can I use Fda Catalyst Devices in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add agentii-ai/agentii-investment-intelligence --skill fda-catalyst-devices -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/fda-catalyst-devices, .gemini/skills/fda-catalyst-devices, .github/skills/fda-catalyst-devices and .opencode/skills/fda-catalyst-devices in your project.

What does Fda Catalyst Devices need to run?

SKILL.md names no scripts, command-line tools or credentials: Fda Catalyst Devices is instructions for the agent only.

Does Fda Catalyst Devices access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Fda Catalyst Devices safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. Review the folder before installing.

What licence does Fda Catalyst Devices use?

Fda Catalyst Devices is published under the Apache-2.0 licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Fda Catalyst Devices use?

About 1.9k tokens (SKILL.md is roughly 7.5k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 1.2k tokens, read only when the agent opens those files.

What are the alternatives to Fda Catalyst Devices?

Skills that share tags, products or a category with Fda Catalyst Devices: CCPM Project Management (automazeio/ccpm, 8.4k stars), Uv (astral-sh/claude-code-plugins, 313 stars), Project Management (kunchenguid/firstmate, 7.7k stars) and Hivemind Goals (activeloopai/hivemind, 1.6k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Fda Catalyst Devices?

agentii-ai (a GitHub user) maintains it in agentii-ai/agentii-investment-intelligence, which has 207 GitHub stars. The repository holds 79 skills in this directory. The repository was last updated on September 29, 2026.

Source: agentii-ai/agentii-investment-intelligence on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.