idea-019 · assessment

What has to be true, and what it costs to be wrong

posture: repair-pending against P0 the original shape stated 2026-09-29 Ask about the assessment ↗

Everywhere else in this packet answers is it true?. This page answers and then what? — for each way this opportunity can fail, what breaks if it does, where the evidence currently stands, and what the cheapest test would be. The bands below are recomputed live from the pillars and the candidate's current tags; they are not read out of the file.

What to do next

Ordered by exposure, and inside a band by what it costs to settle — of the things that could end this, the one you can find out about today is at the top.

  1. 1blockingB7 A standard-sized controller plus garment, built from parts with two suppliers each, has to cost less per patient than Medicare pays, including replacement garments, at a volume the patient population supports, through suppliers willing to stock it. If the margin is not there, there is no business.
    Precisely: It is a business. A stock-sized controller-plus-garment system, built from dual-source parts through a standard test campaign, costs less per patient than Medicare pays for it, at the allowable and in the cadence Medicare actually pays, including the garments that wear out. That holds at a volume the prescribable population supports and through a supplier channel that will carry it. The margin pays back the fixed programme
    fatal if falseholed
    cheap — first REQ-0125 Full-text retrieval of DME MAC LCD L33829…, the full text of LCD (local coverage determination) L33829 (a Medicare local coverage determination number) and its policy article, which says whether replacement garments are paid separately (claim 122unconfirmed). With the compressor family now a one-time purchase (IR-20 claim 117 came back refuted absorbed the refutation of claim 117refuted), that is the only recurring line left. Then Operations' cost build-up (REQ-0123 What is the expected unit cost of goods, REQ-0114 What unit does the idea-019 money model…) against the published purchase allowables. The fetch REQ-0139 Find the CMS DMEPOS fee schedule file in… asked for has already been made (claims 107 and 117)
    Rests on 2 verified, 1 refuted, 15 unconfirmed

    claim 22verified, claim 23unconfirmed, claim 24unconfirmed, claim 36unconfirmed, claim 37unconfirmed, claim 50unconfirmed, claim 92unconfirmed, claim 93unconfirmed, claim 94unconfirmed, claim 95unconfirmed, claim 96unconfirmed, claim 97unconfirmed, claim 107verified, claim 112unconfirmed, claim 114unconfirmed, claim 117refuted, claim 122unconfirmed, claim 123unconfirmed

  2. 2criticalB6 Neurologists and autonomic specialists have to prescribe a piece of equipment for a condition they currently treat with two drugs, and handle the paperwork, because the belt does something those drugs cannot: it does not raise blood pressure when the patient lies down. If they will not prescribe it, there is no business.
    Precisely: Neurologists and autonomic specialists will prescribe a DME (durable medical equipment) device into an indication they manage with midodrine and droxidopa, and will carry the prescription and prior-authorisation paperwork. The reason they do is a difference those drugs' labels actually leave open: no treatment effect while supine
    fatal if falseopen
    cheap — the prescriber instrument REQ-0140 Specify the primary research that would… asks Commercial to specify, fielded as structured calls to 15-20 movement-disorder neurologists and autonomic specialists, plus REQ-0138 What do the current FDA labels for… (the midodrine and droxidopa label text, with set IDs)
    Rests on 3 unconfirmed

    claim 11unconfirmed, claim 29unconfirmed, claim 30unconfirmed

  3. 3criticalB5 People with Parkinson disease and similar conditions, who shake, are stiff and struggle with their hands, have to put on, charge and run a powered belt every day, tolerate the squeeze whenever they are upright, and feel enough relief early on to keep wearing it. If they stop wearing it, there is no business.
    Precisely: People with PD (Parkinson disease), MSA (multiple system atrophy) or PAF (pure autonomic failure), with tremor, rigidity and impaired dexterity, will don, charge and operate a powered abdominal garment every day. They will tolerate sustained compression through every upright period, and feel enough relief in the first weeks to keep wearing it
    fatal if falseopen
    funded — Clinical's 4-week single-arm home-use feasibility study in at least 20 adults (claim 99unconfirmed), with the donning, early-benefit and tolerance endpoints REQ-0141 Can the home-use feasibility study in your… asks for. It needs a built device
    Rests on 4 unconfirmed

    claim 28unconfirmed, claim 38unconfirmed, claim 39unconfirmed, claim 99unconfirmed

  4. 4highB1 Worn the way it is designed, inflating to about 40 mmHg (millimetres of mercury) when the wearer stands, the belt has to reduce dizziness and fainting more than a sham does, by a margin a doctor would act on, including in people with Parkinson disease. If it does not, there is no product.
    Precisely: Worn in its own configuration, posture-triggered at about 40 mmHg rather than manually pre-inflated for a short stand, the device reduces orthostatic symptom burden against a sham in primary autonomic failure, by a margin a prescriber would act on, including in Parkinson disease
    fatal if falsepartial
    cheap — REQ-0137 Has any result of NCT03482297, a search of the NCT03482297 (a ClinicalTrials.gov registration number) investigators' publications, conference abstracts and the NIH RePORTER outputs of award 5R01HL144568 for the one double-blind sham-controlled result of this mechanism. A posted or published null fires trigger T1. The settling artifact after that is Clinical's pre-specified 12-week pivotal (claim 100unconfirmed)
    Rests on 1 verified, 4 unconfirmed

    claim 5verified, claim 46unconfirmed, claim 98unconfirmed, claim 100unconfirmed, claim 101unconfirmed

  5. 5highB2 Inflating on standing has to be the right idea: quick enough to help, and never squeezing a wearer who is lying down for longer than is safe, in patients who often already have high blood pressure when lying flat. If posture triggering cannot be made safe, the device becomes a manually operated belt.
    Precisely: Posture triggering is the right defining feature. It inflates soon enough after standing to help, and in PD, MSA and PAF patients, including those with camptocormia and dyskinesia, it never holds pressure on a recumbent wearer beyond a bound that is harmless in a population where 30-46% have supine hypertension. It vents under every single fault through a path that does not depend on firmware
    reshaping if falseopen
    cheap — two answers that decide trigger T2 before anything is built. REQ-0117 If supine exposure to 40 mmHg abdominal…, Clinical's answer on whether a 60-second supine exposure is harmless in this population, and REQ-0119 Literature pass, the published false-upright rates for single trunk-worn sensors split by camptocormia and dyskinesia. After those come Technology's video-referenced classifier study and fault-injection bench rig
    Rests on 9 unconfirmed

    claim 31unconfirmed, claim 45unconfirmed, claim 48unconfirmed, claim 49unconfirmed, claim 108unconfirmed, claim 109unconfirmed, claim 110unconfirmed, claim 111unconfirmed, claim 113unconfirmed

  6. 6highB3 Medicare has to pay for it as home medical equipment, under an existing billing code, with a coverage rule that reaches this condition, and most patients have to be on Medicare. If Medicare does not pay, there is no payer and no business.
    Precisely: Medicare pays for it, for most of the patients who get it. The device is Part B durable medical equipment, both as a reusable three-year controller and as an item that is medical, not useful absent illness, and meant for the home. It can be billed under a code. A DME MAC (durable medical equipment Medicare administrative contractor) or national coverage policy reaches nOH (neurogenic orthostatic hypotension), and no existing NCD (national coverage determination) captures it first. Most prescribed patients are Medicare beneficiaries, and Medicare Advantage (Medicare Advantage) follows the Part B outcome
    fatal if falsepartial
    cheap — three document reads. REQ-0125 Full-text retrieval of DME MAC LCD L33829… (the full text of LCD L33829 and its policy article), REQ-0147 What evidentiary standard does Medicare… (the written evidentiary standard a DME MAC LCD or an NCD applies), and a read of 42 CFR 414.202 and the Medicare Benefit Policy Manual's DME chapter against conditions (3)-(5) (claim 121unconfirmed). The CMS (Centers for Medicare & Medicaid Services) acts themselves are post-authorisation and human
    Rests on 2 verified, 10 unconfirmed

    claim 10unconfirmed, claim 32unconfirmed, claim 33unconfirmed, claim 40unconfirmed, claim 41unconfirmed, claim 44unconfirmed, claim 115unconfirmed, claim 116verified, claim 118unconfirmed, claim 119unconfirmed, claim 120verified, claim 121unconfirmed

  7. 7moderateB8 No patent still in force, including a known university family, covers posture-triggered abdominal compression for this condition without a licence that can actually be had. If one does, the product needs a licence or a redesign.
    Precisely: Nothing stands between the device and a US sale, and there is something to own. No granted, in-force claim of the Vanderbilt family, and no other live art, reads on posture-triggered or servo-controlled abdominal compression for OH (orthostatic hypotension) without a licence that is actually available
    reshaping if falsepartial
    cheap — REQ-0110 Legal status and family of US2015313608, the legal status, family, granted claims and assignee of US2015313608 from the patent office record, then the CPC and assignee landscape in REQ-0111 A US patent landscape over…. An enquiry to the rights holder is a human act and a Tier 3 disclosure
    Rests on 1 verified, 5 unconfirmed

    claim 26verified, claim 43unconfirmed, claim 88unconfirmed, claim 89unconfirmed, claim 90unconfirmed, claim 91unconfirmed

  8. 8moderateB4 The route to market is a De Novo (De Novo classification request) request on clinical data, with no cleared device already carrying this use and no competitor getting there first. If a competitor or a different route appears, the plan changes shape.
    Precisely: The route to market is a Class II (FDA device class II) De Novo on clinical data of the NCT03482297 design, with the 870.5800 510(k) (premarket notification) repositioning kept open. No cleared device already carries the indication, and no other sponsor gets there first
    reshaping if falsepartial
    project — REQ-0135 Is there any FDA 510 (an indication-level search, and whether FOIA is the only route to the six pre-1996 anti-shock trouser IFUs), REQ-0136 Who else is developing a powered (the competitor sweep, starting from Isotech ISO (International Organization for Standardization)-101), then the Pre-Submission question set drafted under REQ-0142 Draft the Pre-Submission and filed by a human
    Rests on 3 verified, 6 unconfirmed

    claim 3unconfirmed, claim 34unconfirmed, claim 52verified, claim 55verified, claim 102unconfirmed, claim 103unconfirmed, claim 104verified, claim 105unconfirmed, claim 106unconfirmed

The assessment, as written the bet, each pillar's reasoning, the regrades

Assessment — idea-019

A home-use prescription abdominal binder that inflates when the wearer stands, for symptomatic neurogenic orthostatic hypotension in Parkinson disease, MSA and pure autonomic failure. It is built to be paid for as Part B durable medical equipment.

This file carries no confidence tags. It cites them: [claim N: tag] reads claim N of the candidate file with the tag it carries there, and check_assessment.py refuses a citation that disagrees. It moves no score, no stage: and no status:.

How these gradings were made, stated up front because they are not fully prospective. This is the first assessment of idea-019, stated on 2026-09-29 against P0 the original shape, the shape as generated. Every consequence class below was set on 2026-09-29, after the Verifier had tagged claims 1-120. For every pillar resting on those claims, the grading is a reconstruction. The limit on the damage is the one the loop record uses. Each class was set from what the register's "If it is false" column and the binding chair's position say breaks, not from the tag. Nothing in the file was refuted when the classes were set, so no grading here was chosen to keep a refutation away from a fatal pillar. Only claims 121-123 were untagged when these classes were set. This file appended them (see the last section).

Rebuilt the same day, after the first refutation (turn 3). Later on 2026-09-29 the Verifier re-checked the payment claims against the cached July 2026 DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) fee schedule. claim 107verified moved to verified and claim 117refuted to refuted, and B7 It is a business. A stock-sized… derived blocking. The loop record answers that with IR-20 claim 117 came back refuted (absorb). This rebuild keeps against_pivot: P0 the original shape, because pivot: has not moved and there is no new shape to restate the bet for. No consequence class was changed. claim 117refuted stays under B7 It is a business. A stock-sized…, where the first statement put it before the tag arrived. Moving a refuted claim to a softer pillar after the answer came back is the move this file's graded: dates exist to expose. What changed is the text around it: the bet's payment sentence, B7 It is a business. A stock-sized…'s settled by:, the rental shape among the neighbours, and the notes below.

Register coverage made some rests on: lists wider than this file would have drawn them. The checker requires every one of the loop record's 63 live register rows to sit under some pillar. Each row is placed where its own "If it is false" column lands. Where that pulled in a verified claim the pillar would survive without, and so lifted a standing, the last section says so (B1 Worn in its own configuration, B3 Medicare pays for it, B7 It is a business. A stock-sized…, B8 Nothing stands between the device and a US…).

The bet

A neurologist or autonomic specialist has a patient with PD, MSA or pure autonomic failure who still gets dizzy or faint on standing, despite fluids, salt and stockings. Today that patient gets midodrine or droxidopa claim 11unconfirmed, through the pharmacy benefit, with a supine-hypertension liability. The bet is that the specialist will instead write, or add, a prescription for a powered abdominal binder. The patient wears it under clothing all day. It inflates to about 40 mmHg when a posture sensor says the patient is upright and vents when they sit or lie down, so the treatment never acts while the patient is recumbent. Medicare Part B (Medicare Part B) pays for it as durable medical equipment under the pneumatic-compressor code family (E0650 (a HCPCS code for durable medical equipment)-E0652) claim 10unconfirmed. That family is paid as a purchase. The July 2026 fee schedule puts E0650-E0652 in the inexpensive-or-routinely-purchased category, not capped rental, which refutes the chair's reading that Medicare rents it claim 117refuted. So the P0 the original shape premise of a patient-owned purchase stands at the level of the code family. What the device would actually bill under is still open claim 40unconfirmed, and that choice alone moves the one-time payment by a factor of about seven, from E0650 to E0652. The shape is deliberately not built on a coverage-at-authorization pathway. RAPID is a notice not in force claim 15verified, and TCET is paused claim 16verified. The mechanism has one published randomized precedent claim 5verified. That study activated the binder manually, just before a stand of ten minutes or less claim 73verified. The design's defining feature, posture-triggered all-day inflation, therefore has no clinical precedent of its own. The claim to efficacy, the claim to safety and the claim to payment are all currently the file's own design intent.

The shapes it is not. Each survives a different pillar failing:

Pillars

Eight. Four are graded fatal: the device must reduce symptoms (B1 Worn in its own configuration), Medicare must pay for it (B3 Medicare pays for it), patients must wear it (B5 People with PD), and specialists must prescribe it (B6 Neurologists and autonomic specialists will…). The margin (B7 It is a business. A stock-sized…) is a fifth. The other three each have a named shape waiting behind them in the loop record's pivot triggers or in the device_class routes. That is what grading them reshaping means here.

Standing

Rendered, never written: python3 engine/scripts/check_assessment.py --candidate idea-019 --render

PillarConsequenceRests onStandingExposureCost
B1 Worn in its own configurationfatal1 verified, 4 unconfirmedpartialhighcheap
B2 Posture triggering is the right defining…reshaping9 unconfirmedopenhighcheap
B3 Medicare pays for itfatal2 verified, 10 unconfirmedpartialhighcheap
B4 The route to market is a Class II De Novo…reshaping3 verified, 6 unconfirmedpartialmoderateproject
B5 People with PDfatal4 unconfirmedopencriticalfunded
B6 Neurologists and autonomic specialists will…fatal3 unconfirmedopencriticalcheap
B7 It is a business. A stock-sized…fatal2 verified, 1 refuted, 15 unconfirmedholedblockingcheap
B8 Nothing stands between the device and a US…reshaping1 verified, 5 unconfirmedpartialmoderatecheap

Decision queue

Same render. Worst exposure first; inside a band, cheapest first.

#ExposurePillarStandingCostCheapest test that would move it
1blockingB7 It is a business. A stock-sized… — It is a business. A stock-sized controller-plus-garment system, built from dual-source parts through a standard test campaign, costs less per patient than Medicare pays for it, at the allowable and in the cadence Medicare actually pays, including the garments that wear out. That holds at a volume the prescribable population supports and through a supplier channel that will carry it. The margin pays back the fixed programmeholedcheapfirst REQ-0125 Full-text retrieval of DME MAC LCD L33829…, the full text of LCD L33829 and its policy article, which says whether replacement garments are paid separately (claim 122unconfirmed). With the compressor family now a one-time purchase (IR-20 claim 117 came back refuted absorbed the refutation of claim 117refuted), that is the only recurring line left. Then Operations' cost build-up (REQ-0123 What is the expected unit cost of goods, REQ-0114 What unit does the idea-019 money model…) against the published purchase allowables. The fetch REQ-0139 Find the CMS DMEPOS fee schedule file in… asked for has already been made (claims 107 and 117)
2criticalB6 Neurologists and autonomic specialists will… — Neurologists and autonomic specialists will prescribe a DME device into an indication they manage with midodrine and droxidopa, and will carry the prescription and prior-authorisation paperwork. The reason they do is a difference those drugs' labels actually leave open: no treatment effect while supineopencheapthe prescriber instrument REQ-0140 Specify the primary research that would… asks Commercial to specify, fielded as structured calls to 15-20 movement-disorder neurologists and autonomic specialists, plus REQ-0138 What do the current FDA labels for… (the midodrine and droxidopa label text, with set IDs)
3criticalB5 People with PD — People with PD, MSA or PAF, with tremor, rigidity and impaired dexterity, will don, charge and operate a powered abdominal garment every day. They will tolerate sustained compression through every upright period, and feel enough relief in the first weeks to keep wearing itopenfundedClinical's 4-week single-arm home-use feasibility study in at least 20 adults (claim 99unconfirmed), with the donning, early-benefit and tolerance endpoints REQ-0141 Can the home-use feasibility study in your… asks for. It needs a built device
4highB1 Worn in its own configuration — Worn in its own configuration, posture-triggered at about 40 mmHg rather than manually pre-inflated for a short stand, the device reduces orthostatic symptom burden against a sham in primary autonomic failure, by a margin a prescriber would act on, including in Parkinson diseasepartialcheapREQ-0137 Has any result of NCT03482297, a search of the NCT03482297 investigators' publications, conference abstracts and the NIH RePORTER outputs of award 5R01HL144568 for the one double-blind sham-controlled result of this mechanism. A posted or published null fires trigger T1. The settling artifact after that is Clinical's pre-specified 12-week pivotal (claim 100unconfirmed)
5highB2 Posture triggering is the right defining… — Posture triggering is the right defining feature. It inflates soon enough after standing to help, and in PD, MSA and PAF patients, including those with camptocormia and dyskinesia, it never holds pressure on a recumbent wearer beyond a bound that is harmless in a population where 30-46% have supine hypertension. It vents under every single fault through a path that does not depend on firmwareopencheaptwo answers that decide trigger T2 before anything is built. REQ-0117 If supine exposure to 40 mmHg abdominal…, Clinical's answer on whether a 60-second supine exposure is harmless in this population, and REQ-0119 Literature pass, the published false-upright rates for single trunk-worn sensors split by camptocormia and dyskinesia. After those come Technology's video-referenced classifier study and fault-injection bench rig
6highB3 Medicare pays for it — Medicare pays for it, for most of the patients who get it. The device is Part B durable medical equipment, both as a reusable three-year controller and as an item that is medical, not useful absent illness, and meant for the home. It can be billed under a code. A DME MAC or national coverage policy reaches nOH, and no existing NCD captures it first. Most prescribed patients are Medicare beneficiaries, and Medicare Advantage follows the Part B outcomepartialcheapthree document reads. REQ-0125 Full-text retrieval of DME MAC LCD L33829… (the full text of LCD L33829 and its policy article), REQ-0147 What evidentiary standard does Medicare… (the written evidentiary standard a DME MAC LCD or an NCD applies), and a read of 42 CFR 414.202 and the Medicare Benefit Policy Manual's DME chapter against conditions (3)-(5) (claim 121unconfirmed). The CMS acts themselves are post-authorisation and human
7moderateB8 Nothing stands between the device and a US… — Nothing stands between the device and a US sale, and there is something to own. No granted, in-force claim of the Vanderbilt family, and no other live art, reads on posture-triggered or servo-controlled abdominal compression for OH without a licence that is actually availablepartialcheapREQ-0110 Legal status and family of US2015313608, the legal status, family, granted claims and assignee of US2015313608 from the patent office record, then the CPC and assignee landscape in REQ-0111 A US patent landscape over…. An enquiry to the rights holder is a human act and a Tier 3 disclosure
8moderateB4 The route to market is a Class II De Novo… — The route to market is a Class II De Novo on clinical data of the NCT03482297 design, with the 870.5800 510(k) repositioning kept open. No cleared device already carries the indication, and no other sponsor gets there firstpartialprojectREQ-0135 Is there any FDA 510 (an indication-level search, and whether FOIA is the only route to the six pre-1996 anti-shock trouser IFUs), REQ-0136 Who else is developing a powered (the competitor sweep, starting from Isotech ISO-101), then the Pre-Submission question set drafted under REQ-0142 Draft the Pre-Submission and filed by a human

Regrades

None. The first statement set every class on 2026-09-29. The turn-3 rebuild the same day changed no class. B7 It is a business. A stock-sized… stays fatal with claim 117refuted under it (see the note at the top), and B7 It is a business. A stock-sized…'s cost: stays cheap because its first move is now REQ-0125 Full-text retrieval of DME MAC LCD L33829… instead of the fetch that has already been made.

What this does not say

What each claim is load-bearing for 66 of 142 claims carry a pillar

Every claim in the candidate file, with the pillars that rest on it and the materiality it inherits from them. 66 of 142 are read by a pillar; the rest are context — true, possibly checked, and carrying nothing. That is not an insult and it is not an error: it is the only view in this repo that can tell you where the verification effort went.

ClaimTagMaterialityPillarsRegister
claim 1verifiedverifiedcontext——
claim 2verifiedverifiedcontext——
claim 3unconfirmedunconfirmedreshapingB4 The route to market is a Class II De Novo…A1 No FDA 510
claim 4unconfirmedunconfirmedcontext——
claim 5verifiedverifiedfatalB1 Worn in its own configurationA4 PMID 27271310
claim 6verifiedverifiedcontext——
claim 7verifiedverifiedcontext——
claim 8unconfirmedunconfirmedcontext——
claim 9verifiedverifiedcontext——
claim 10unconfirmedunconfirmedfatalB3 Medicare pays for itA17 HCPCS Level II codes E0650
claim 11unconfirmedunconfirmedfatalB6 Neurologists and autonomic specialists will…A15 Midodrine and droxidopa are FDA-approved…
claim 12verifiedverifiedcontext——
claim 13verifiedverifiedcontext——
claim 14verifiedverifiedcontext——
claim 15verifiedverifiedcontext——
claim 16verifiedverifiedcontext——
claim 17verifiedverifiedcontext——
claim 18verifiedverifiedcontext——
claim 19verifiedverifiedcontext——
claim 20unconfirmedunconfirmedcontext——
claim 21unconfirmedunconfirmedcontext——
claim 22verifiedverifiedfatalB7 It is a business. A stock-sized…A24 TAM component 2 of 4
claim 23unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A20 TAM component 3 of 4
claim 24unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A25 TAM component 4 of 4
claim 25verifiedverifiedcontext——
claim 26verifiedverifiedreshapingB8 Nothing stands between the device and a US…A26 FTO — named family: US patent application…
claim 27unconfirmedunconfirmedcontext——
claim 28unconfirmedunconfirmedfatalB5 People with PDA11 Assumption
claim 29unconfirmedunconfirmedfatalB6 Neurologists and autonomic specialists will…A13 Assumption
claim 30unconfirmedunconfirmedfatalB6 Neurologists and autonomic specialists will…A14 Assumption
claim 31unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A6 Mechanism and clinical-risk reasoning
claim 32unconfirmedunconfirmedfatalB3 Medicare pays for itA16 Assumption
claim 33unconfirmedunconfirmedfatalB3 Medicare pays for itA22 Assumption
claim 34unconfirmedunconfirmedreshapingB4 The route to market is a Class II De Novo…A28 No competitor company was identified by the…
claim 35verifiedverifiedcontext——
claim 36unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A30 Adults with symptomatic neurogenic…
claim 37unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A23 A DMEPOS supplier will stock
claim 38unconfirmedunconfirmedfatalB5 People with PDA12 A patient with symptomatic neurogenic…
claim 39unconfirmedunconfirmedfatalB5 People with PDA10 Adults with primary autonomic failure will…
claim 40unconfirmedunconfirmedfatalB3 Medicare pays for itA18 CMS will assign a HCPCS Level II code under…
claim 41unconfirmedunconfirmedfatalB3 Medicare pays for itA19 A Medicare national coverage determination…
claim 42unconfirmedunconfirmedcontext——
claim 43unconfirmedunconfirmedreshapingB8 Nothing stands between the device and a US…A27 The patent family published as US2015313608
claim 44unconfirmedunconfirmedfatalB3 Medicare pays for itA21 Most US adults with symptomatic neurogenic…
claim 45unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A9 A posture-triggered abdominal compression…
claim 46unconfirmedunconfirmedfatalB1 Worn in its own configurationA5 This candidate's own bladder geometry and…
claim 47unconfirmedunconfirmedcontext——
claim 48unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A7 A torso-mounted accelerometer or…
claim 49unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A8 A bench rig can demonstrate that the device…
claim 50unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A29 A garment platform in a small number of…
claim 51verifiedverifiedcontext——
claim 52verifiedverifiedreshapingB4 The route to market is a Class II De Novo…A3 openFDA device classification lists product…
claim 53unconfirmedunconfirmedcontext——
claim 54verifiedverifiedcontext——
claim 55verifiedverifiedreshapingB4 The route to market is a Class II De Novo…A2 No granted De Novo request in the FDA De…
claim 56unconfirmedunconfirmedcontext——
claim 57verifiedverifiedcontext——
claim 58verifiedverifiedcontext——
claim 59verifiedverifiedcontext——
claim 60verifiedverifiedcontext——
claim 61unconfirmedunconfirmedcontext——
claim 62unconfirmedunconfirmedcontext——
claim 63verifiedverifiedcontext——
claim 64verifiedverifiedcontext——
claim 65verifiedverifiedcontext——
claim 66verifiedverifiedcontext——
claim 67verifiedverifiedcontext——
claim 68verifiedverifiedcontext——
claim 69verifiedverifiedcontext——
claim 70unconfirmedunconfirmedcontext——
claim 71verifiedverifiedcontext——
claim 72verifiedverifiedcontext——
claim 73verifiedverifiedcontext——
claim 74verifiedverifiedcontext——
claim 75verifiedverifiedcontext——
claim 76verifiedverifiedcontext——
claim 77verifiedverifiedcontext——
claim 78verifiedverifiedcontext——
claim 79verifiedverifiedcontext——
claim 80verifiedverifiedcontext——
claim 81verifiedverifiedcontext——
claim 82verifiedverifiedcontext——
claim 83verifiedverifiedcontext——
claim 84verifiedverifiedcontext——
claim 85verifiedverifiedcontext——
claim 86verifiedverifiedcontext——
claim 87verifiedverifiedcontext——
claim 88unconfirmedunconfirmedreshapingB8 Nothing stands between the device and a US…A31 No patent in the INPADOC family of US…
claim 89unconfirmedunconfirmedreshapingB8 Nothing stands between the device and a US…A32 Outside the US2015313608 family
claim 90unconfirmedunconfirmedreshapingB8 Nothing stands between the device and a US…—
claim 91unconfirmedunconfirmedreshapingB8 Nothing stands between the device and a US…—
claim 92unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A35 The device described in idea-019's…
claim 93unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A36 Under FDA's guidance on the use of ISO…
claim 94unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A37 A home-use
claim 95unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…—
claim 96unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A39 At the annual production volume idea-019's…
claim 97unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A40 The miniature air pump
claim 98unconfirmedunconfirmedfatalB1 Worn in its own configurationA41 The Vanderbilt randomized
claim 99unconfirmedunconfirmedfatalB5 People with PDA42 In a single-arm home-use feasibility study…
claim 100unconfirmedunconfirmedfatalB1 Worn in its own configurationA43 A randomized
claim 101unconfirmedunconfirmedfatalB1 Worn in its own configurationA44 The symptom benefit of servo-controlled…
claim 102unconfirmedunconfirmedreshapingB4 The route to market is a Class II De Novo…A45 FDA would classify a powered
claim 103unconfirmedunconfirmedreshapingB4 The route to market is a Class II De Novo…A46 None of the 510
claim 104verifiedverifiedreshapingB4 The route to market is a Class II De Novo…A47 510(k) K153311 (Tactile Systems Flexitouch…
claim 105unconfirmedunconfirmedreshapingB4 The route to market is a Class II De Novo…—
claim 106unconfirmedunconfirmedreshapingB4 The route to market is a Class II De Novo…A49 FDA would accept
claim 107verifiedverifiedfatalB7 It is a business. A stock-sized…A50 The CMS DMEPOS fee schedule in force for…
claim 108unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A51 A posture classifier running on a single…
claim 109unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A52 A battery-powered pneumatic unit small…
claim 110unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A53 A bench rig demonstrates that the device…
claim 111unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A54 An independent recumbency interlock
claim 112unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A55 In no more than three stock garment sizes
claim 113unconfirmedunconfirmedreshapingB2 Posture triggering is the right defining…A56 The posture classifier's…
claim 114unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…A57 A wearable unit powered by a battery of 20…
claim 115unconfirmedunconfirmedfatalB3 Medicare pays for itA58 In the October 2026 CMS HCPCS Level II file
claim 116verifiedverifiedfatalB3 Medicare pays for itA59 NCD 280.6
claim 117refutedrefutedfatalB7 It is a business. A stock-sized…—
claim 118unconfirmedunconfirmedfatalB3 Medicare pays for itA61 DME MAC local coverage determination L33829
claim 119unconfirmedunconfirmedfatalB3 Medicare pays for itA62 This candidate's controller
claim 120verifiedverifiedfatalB3 Medicare pays for itA21 Most US adults with symptomatic neurogenic…
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claim 123unconfirmedunconfirmedfatalB7 It is a business. A stock-sized…—
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Exposure is not truth, and no band here is a verdict. critical means an unanswered question that could end the thing, which is the ordinary condition of an early opportunity. resolved means the claims under a pillar came back verified, not that the pillar is right. And these bands do not compare between ideas — they say where attention goes next on this one.

Words on this page27 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md
21 CFR
Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
510(k)
premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
Class II
FDA device class II — moderate-risk devices, usually cleared by 510(k)
Class III
FDA device class III — the highest-risk devices, usually approved by PMA
CMS
Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
COGS
cost of goods sold — what it costs to make one unit
De Novo
De Novo classification request — the FDA route for a new, lower-risk device with no comparable product to point at; longer than a 510(k), usually needs clinical data
DME
durable medical equipment — equipment a patient uses at home, such as a pump or a stimulator, that Medicare pays for under its own rules
DME MAC
durable medical equipment Medicare administrative contractor — one of the four regional contractors that process Medicare's home-equipment claims and write its local coverage rules
DMEPOS
durable medical equipment, prosthetics, orthotics and supplies — the Medicare benefit and fee schedule that home equipment is paid under
E####
a HCPCS code for durable medical equipment — one billing code for a piece of home equipment; the letter E and four digits
FDA
US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
ISO
International Organization for Standardization — the body whose numbered standards devices and laboratories are tested against
L#####
a Medicare local coverage determination number — the public id of one local coverage rule; the letter L and five digits
LCD
local coverage determination — a Medicare contractor's rule, valid in its region, saying when something is covered
Medicare Advantage
Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
Medicare Part B
Medicare Part B — the part of Medicare that pays for outpatient care and equipment used at home
mmHg
millimetres of mercury — the unit blood pressure, and the suction of a wound pump, are measured in
MSA
multiple system atrophy — a rare degenerative brain disease that, among other things, breaks blood-pressure control
NCD
national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
NCD ###.#
a Medicare national coverage determination number — the public id of one national coverage rule
NCT########
a ClinicalTrials.gov registration number — the public id of one registered clinical trial
nOH
neurogenic orthostatic hypotension — blood pressure that falls on standing because the nerves that should tighten the blood vessels have failed
OH
orthostatic hypotension — blood pressure that falls on standing
PAF
pure autonomic failure — a rare condition in which only the nerves controlling automatic functions such as blood pressure fail
PD
Parkinson disease — Parkinson disease
PMA
premarket approval — the FDA route for the highest-risk devices; years and clinical trials