idea-011 · viability deck
Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.
The chair: the investor, and the operator who has to sell a wearable-plus-algorithm service into a reimbursement pathway that does not exist yet.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-011.md — the number is the claim's position in its ## Claims list, the tag is copied from it and never adjusted here. A [no claim] marker means nothing in the file speaks to this. No number appears here that isn't in a claim, and there is no ask slide. This is the first deck built for this candidate. See docs/deck-spec.md.
Would have to be true: Medicare (or a commercial analog) would have to pay for this device as a "separately payable" service, which itself requires the device to hold FDA Breakthrough Device Designation and be at the IDE-presubmission stage under CMS's proposed RAPID coverage pathway — or an entirely different, currently unidentified reimbursement route would have to exist instead.
Where it stands: CMS's own notice is real and verified as to its text: RAPID eligibility requires "separately payable" status [claim 4: verified], is limited to Class II/III Breakthrough-designated devices entering at the IDE-presubmission stage [claim 5: verified], excludes IVDs by name — this device is not an IVD on its stated intended use [claim 6: verified] — and is a notice with an open comment period, not in force, closing 2026-10-13 [claim 7: verified]. Whether this device actually holds or would hold Breakthrough designation is unconfirmed: AliveCor's KardiaK, the closest analog, reportedly received Breakthrough designation in 2018 [claim 1: unconfirmed], but no connector in this repo checks designation status directly, and FDA structurally does not disclose it pre-authorization [claim 14: unconfirmed]. No HCPCS code, payment rate, or coverage policy specific to this service exists in any queried source [claim 11: unconfirmed]. The desirability deck's Slide 4 covers the same gap from the patient's side — what an unfinalized pathway means as out-of-pocket exposure.
What would settle it: Federal Register docket tracking on document 2026-16368 past 2026-10-13; a human consult of FDA's Breakthrough Devices Program page for this specific device; a data/-backed CMS HCPCS/coverage pull once the relevant files are populated.
If it's false: There is no payer and no budget line, and the reimbursement pathway score (the one factor this file has actually verified anything for, at 1/5) has nowhere further to go without a finalized rule.
Would have to be true: Code existence, payment amount, and coverage policy are three separate questions and all three have to land.
Where it stands:
What would settle it: The same hcpcs/payment/coverage connector pulls named on Slide 1, plus a search for any existing remote-physiologic-monitoring analog code's applicability — not reproduced here since AMA-licensed descriptors cannot be quoted.
If it's false: Reimbursement pathway sits at floor (1/5) and stays there — one of the two factors the Stage 5 gate checks jointly against a floor of 2/5.
Would have to be true: A defined population, at a known hyperkalemia/monitoring-need rate, at an established price, times a reachable share — each factor named separately, not one headline number.
Where it stands:
What would settle it: Direct extraction of a 2024-vintage USRDS Medicare FFS CKD beneficiary count (attempted twice, not yet extracted — [claim 10: unconfirmed], [claim 19: unconfirmed]); a CMS payment rate as a price proxy once coverage exists; a market-adoption estimate for reachable share (human-attached, licensed data).
If it's false: TAM scoring below floor (2/5) is an automatic kill condition on its own, independent of the joint regulatory/reimbursement floor check.
Would have to be true: A predicate device would have to exist for a 510(k) route, or — if not — a De Novo submission (a longer, more expensive path with no existing product-code family to shorten it) would have to be budgeted for from the start.
Where it stands: No 510(k) clearance or De Novo grant for KardiaK, the closest analog, has been located [claim 2: unconfirmed]. A broadened openFDA search found zero devices under any name carrying a hyperkalemia, electrolyte, or potassium indication, and confirmed all ten product codes in the one classification family built for ECG-based AI "notification software" cover unrelated cardiac conditions — none for hyperkalemia [claim 25: unconfirmed] (mixed finding). A related but tangential finding — that the classification family's own regulation_number does not correspond to a real codified CFR section — is genuinely verified but was judged by the Scorer too tangential to this device's own pathway question to move Regulatory pathway off blank [claim 26: verified]. No cost or calendar estimate for either route appears anywhere in this file — [no claim]; this deck states none rather than estimate one.
What would settle it: Published FDA De Novo review-timeline statistics for a comparable product-code family (the QYE reduced-ejection-fraction family is the nearest analog structure, per the domain dossier, though not itself a claim in this file); a populated De Novo bulk-data cache, which does not currently have a known stable source URL [claim 15: unconfirmed].
If it's false: This device is a founding De Novo entrant rather than a 510(k) follow-on, which is the harder, slower, more expensive of the two live routes named in the candidate's own frontmatter.
Would have to be true: A patent position, a data advantage, or a coding requirement a competitor can't meet would have to exist — a mechanism, not an adjective.
Where it stands: No moat mechanism is named as a claim in this file at all — [no claim]. What exists instead is a freedom-to-operate risk running the other direction: AliveCor's KardiaK, on the closest competing mechanism, reportedly holds Breakthrough Device Designation and may hold patent claims covering ECG-morphology-based potassium inference, though no patent number was ever identified and the claim line itself was found truncated in the file and never fully checked [claim 13: unverified]. No patent lookup could be run — the connector requires a specific patent ID, and this environment's PATENTSVIEW_API_KEY is not configured [claim 13: unverified].
What would settle it: A configured PATENTSVIEW_API_KEY and an assignee search for AliveCor and adjacent ECG-hyperkalemia patent families, down to a specific patent number; only then can FTO move past "open question" toward either "blocked" or "clear."
If it's false: If AliveCor (or another entrant) holds a blocking patent with no workaround, that is an automatic kill under the Stage 5 gate regardless of every other score.
Would have to be true: The incumbent field would have to be small enough, or beatable enough, that a founding De Novo entrant still has a viable window.
Where it stands: One entrant is named in the file: AliveCor's KardiaK, reportedly Breakthrough-designated in 2018 [claim 1: unconfirmed] but with no clearance or De Novo grant ever located for it [claim 2: unconfirmed] — a competitor whose own regulatory status is as unresolved as this candidate's. Whether any other company is pursuing the same mechanism is this deck's own write-back, unaddressed by any existing claim [claim 36: unverified]. The broader ECG-AI product-code family (870.2380) that does exist covers ten unrelated cardiac conditions, not hyperkalemia [claim 25: unconfirmed] (mixed finding) — evidence of an active adjacent technology category, not of direct competition.
What would settle it: Distributor and conference-exhibitor searches (not run by this pipeline); FDA's Breakthrough Devices Program page, read by a human, for any newer designation in this space [claim 14: unconfirmed].
If it's false: Read it inverted — if AliveCor's designation is real and current and a second entrant exists that this file hasn't found, competitive intensity is scored too low across the board.
Would have to be true: A single connector call would have to move the reimbursement question from proposal to fact before any more expensive work is funded.
Where it stands: The cheapest lever available is re-running the Federal Register docket check on document 2026-16368 after 2026-10-13, when its comment period closes [claim 7: verified] — that single date either finalizes or kills the only reimbursement pathway this device has ever been checked against. Ahead of any patent search or market study, that is the nearest, cheapest fact this file's own record points to.
What would settle it: python3 -m connectors policy 2026-16368 re-run after 2026-10-13.
If it's false: Nothing here is false — this is a work order with a date already attached to it.
Every condition above with nothing verified behind it. Four verified claims exist [claim 4: verified] through [claim 7: verified], and all four describe the same document's text — what CMS proposed, not whether this device qualifies, not whether it is ever finalized.
If only one thing from this chair could be checked: whether CMS's proposed RAPID coverage pathway (document 2026-16368) is finalized after its comment period closes 2026-10-13, and whether this device would hold the Breakthrough designation and "separately payable" status RAPID requires [claim 7: verified], [claim 1: unconfirmed].
This is the one factor this file has moved any distance on at all — Reimbursement pathway is the single verified-scored factor in the whole candidate, at 1/5, precisely because CMS proposed a real, checkable pathway. Every other viability question (TAM's price, capital's calendar, the moat) either depends on this resolving or is independently blocked regardless of it. A finalized RAPID rule that this device qualifies for would be the first real reimbursement fact this candidate has ever had; a non-finalized or disqualifying outcome leaves Reimbursement at floor and the joint regulatory/reimbursement kill condition one unresolved factor away from mattering.
Naming it is not a recommendation, a gate, or a kill.