How to read a tag. Only
verified counts toward a score — it means a typed connector
resolved this against a primary US federal record.
unconfirmed means the Verifier checked and could not confirm,
which very often means the source could not be queried at all rather than that
the claim is doubtful. refuted means a primary source
contradicts it. unverified means nothing has checked it yet.
No FDA (US Food and Drug Administration) 510(k) (premarket notification) clearance and no De Novo (De Novo classification request) grant for a device indicated to reduce or prevent chemotherapy-induced peripheral neuropathy by limb cooling, limb compression, or both was identified by the Generator's web search.
jurisdiction: US — confidence: unverified — source: Generator's web search; a null web search is not proof of absence, and the FDA 510(k) and De Novo databases were not queried directly.
A Paxman company release states that FDA has identified the De Novo process as an appropriate pathway for review of the Paxman Limb Cryocompression System for the reduction of chemotherapy-induced peripheral neuropathy, and that the system holds regulatory approvals in the UK and Europe for that use.
jurisdiction: US — confidence: unverified — source: found via web search (Inderes-hosted Paxman release, "Paxman Announces FDA Regulatory Progress for Limb Cryocompression System"), a company statement and not a primary FDA record; release date not recorded by the Generator.
ClinicalTrials.gov NCT05642611 (a ClinicalTrials.gov registration number) ("Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy," SWOG, also listed as ICE COMPRESS) is a phase III randomized trial comparing cryocompression, continuous compression, and low cyclic compression using the Paxman Limb Cryocompression System for prevention of taxane-induced peripheral neuropathy.
jurisdiction: US — confidence: unverified — source: found via web search (ClinicalTrials.gov and NCORP listings), not primary-source confirmed; status and results not read.
ClinicalTrials.gov NCT05095051 ("A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy") is a registered study of a limb cryocompression device associated with the National University Hospital, Singapore collaboration.
jurisdiction: US — confidence: unverified — source: found via web search, not primary-source confirmed; design, status and results not read.
ClinicalTrials.gov NCT07064798 ("Cryocompression for CIPN") is a further registered study of cryocompression for chemotherapy-induced peripheral neuropathy.
jurisdiction: US — confidence: unverified — source: found via web search, not primary-source confirmed; sponsor, design and status not read.
Hanai A, et al., "Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial," J Natl Cancer Inst 2018;110(2):141, reported that in breast cancer patients receiving weekly paclitaxel 80 mg/m2, frozen gloves and socks worn on the dominant side for 90 minutes spanning each infusion were followed by significantly less objective and subjective neuropathy on the treated side than on the untreated side.
jurisdiction: US — confidence: unverified — source: found via web search (JNCI article page), not primary-source confirmed; PMID (PubMed identifier) not identified by the Generator. The design is self-controlled and non-randomized between sides, and dominant-side treatment is a known critique.
A randomized controlled trial of frozen-glove cryotherapy to prevent paclitaxel-induced peripheral neuropathy (ACCRU trial RU221511I; PMCID PMC7558814) exists; the Generator recalls that it reported substantial intolerance of the frozen garments and did not show a clear benefit on its primary endpoint, and has not read it.
jurisdiction: US — confidence: unverified — source: trial located via web search; findings are the Generator's recollection, not primary-source confirmed.
PMID 33424755 ("Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial") reports a randomized trial of cryotherapy in this population; its findings were not read.
jurisdiction: US — confidence: unverified — source: found via web search, not primary-source confirmed.
A systematic review and meta-analysis, "Efficacy of cryotherapy in the prevention of chemotherapy-induced peripheral neuropathy," was published in Supportive Care in Cancer in 2024 (DOI 10.1007/s00520-024-08680-3); its pooled findings were not read.
jurisdiction: US — confidence: unverified — source: found via web search, not primary-source confirmed.
FDA De Novo DEN150010 (an FDA De Novo decision number) (DigniCap Scalp Cooling System, Dignitana AB), indicated to reduce the likelihood of chemotherapy-induced alopecia in women with breast cancer, classified the device under 21 CFR (Title 21 of the Code of Federal Regulations) 878.4360 (scalp cooling system), Class II (FDA device class II), product code PMC, prescription use.
jurisdiction: US — confidence: unverified — source: found via web search of the FDA De Novo decision summary (accessdata.fda.gov reviews/DEN150010.pdf), not primary-source confirmed.
CPT (Current Procedural Terminology) Category III codes 0662T and 0663T describe scalp cooling during chemotherapy (initial measurement and calibration of the cap, and subsequent placement and monitoring), which the Generator treats as the coding precedent a limb-cooling device would follow.
jurisdiction: US — confidence: unverified — source: Generator's recollection, not primary-source confirmed; descriptors not read.
No CPT or HCPCS (Healthcare Common Procedure Coding System) code specific to limb cooling or cryocompression during chemotherapy was identified by the Generator.
jurisdiction: US — confidence: unverified — source: Generator's best guess; no code-set lookup performed.
CPT 96413 (chemotherapy administration, intravenous infusion, up to one hour) and 96415 (each additional hour) describe the infusion service during which this device would be used; the Generator believes a clinic-owned device used during that service is not separately payable and would be absorbed into the practice-expense or hospital outpatient payment for it, absent a code of its own.
jurisdiction: US — confidence: unverified — source: Generator's best guess; CPT descriptors and payment rules not read.
21 CFR 890.5720 classifies a water circulating hot or cold pack; the Generator does not know its class or exemption status and asserts neither, and believes it would not admit a neuropathy-prevention claim.
jurisdiction: US — confidence: unverified — source: Generator's best guess; eCFR not read.
Federal Register document 2026-16368 (91 FR 51710) states that eligibility for the coverage pathway it describes is limited to Class II and Class III (FDA device class III) FDA Breakthrough-designated devices, and that entry occurs at the IDE presubmission stage.
jurisdiction: US — confidence: unverified — source: Generator's reading of FR 2026-16368 (CMS (Centers for Medicare & Medicaid Services) notice with comment period, "RAPID" coverage pathway, published 2026-08-11), not primary-source confirmed.
Federal Register document 2026-16368 (91 FR 51710) states that eligibility for that pathway requires the device to be separately payable, that is, billable to Medicare in its own right.
jurisdiction: US — confidence: unverified — source: Generator's reading of FR 2026-16368, not primary-source confirmed.
Federal Register document 2026-16368 (91 FR 51710) contains a provision admitting 510(k)-cleared devices whose primary predicate was De Novo-authorized within 18 months of acceptance into the pathway, within a pathway otherwise limited to Breakthrough-designated devices.
jurisdiction: US — confidence: unverified — source: Generator's reading of FR 2026-16368, not primary-source confirmed; the Generator did not read the provision's exact text.
Federal Register document 2026-16368 (91 FR 51710) is a notice with comment period, not a final rule, with comments closing 2026-10-13, and it states that the Transitional Coverage for Emerging Technologies pathway is paused for new candidates on its publication; nothing in it was in force on the date this candidate was generated.
jurisdiction: US — confidence: unverified — source: Generator's reading of FR 2026-16368, not primary-source confirmed.
Federal Register document 2024-17603 (89 FR 65724), the notice establishing the Transitional Coverage for Emerging Technologies pathway, states that CMS did not anticipate accepting more than five candidates per year into that pathway based on then-current resources.
jurisdiction: US — confidence: unverified — source: Generator's reading of FR 2024-17603, not primary-source confirmed.
Federal Register document 2021-24916 (86 FR 62944) is a final rule repealing the Medicare Coverage of Innovative Technology final rule (FR 2021-00707, 86 FR 2987) before it took effect.
jurisdiction: US — confidence: unverified — source: Generator's reading of FR 2021-24916, not primary-source confirmed.
Public Law 114-255 section 3051 added section 515B to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-3), establishing the Breakthrough Devices Program, under which a device may qualify where it provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition and meets at least one further criterion, including that no approved or cleared alternatives exist or that it offers significant advantages over existing approved or cleared alternatives.
jurisdiction: US — confidence: unverified — source: Generator's best recollection of the statute; statute text not read.
Reasoning, not a fact: once one limb-cooling device is authorized for chemotherapy- induced peripheral neuropathy, a later device for the same indication could qualify for Breakthrough designation only by showing significant advantages over it, which a follower differing mainly in cooling technology and control is unlikely to establish before pivotal data exist; whether chemotherapy-induced peripheral neuropathy meets the "irreversibly debilitating" limb at all is a judgement FDA makes and the Generator has not examined.
jurisdiction: US — confidence: unverified — source: Generator's reasoning.
TAM (total addressable market) component 1 of 4, population base: the American Cancer Society estimated about 310,720 new cases of invasive female breast cancer in the US for 2024.
jurisdiction: US — confidence: unverified — source: Generator's recollection of ACS Cancer Facts & Figures 2024, not primary-source confirmed; ACS is a modelled estimate, not a registry count, and a SEER or USCS registry figure would be the primary substitute.
TAM component 2 of 4, treated fraction: the fraction of US breast cancer patients who receive a weekly paclitaxel regimen is not known to the Generator; no figure is asserted.
jurisdiction: US — confidence: unverified — source: Generator's note; no source identified.
TAM component 3 of 4, clinical fraction: a systematic review and meta-analysis (Seretny M, et al., Pain 2014; the Generator believes PMID 25261162) reported pooled chemotherapy-induced peripheral neuropathy prevalence of about 68% in the first month after chemotherapy, 60% at three months, and 30% at six months or more, across agents.
jurisdiction: US — confidence: unverified — source: Generator's recollection, not primary-source confirmed; the PMID and figures should be checked against the abstract, and the pooled figures are not paclitaxel-specific or US-specific.
TAM component 4 of 4, price per unit: no console price, wrap-set price, or per-course price is asserted; there is no code to anchor one (claim 12unverified).
jurisdiction: US — confidence: unverified — source: Generator's note; no price source identified.
Addressable share: the Generator assumes the addressable population is weekly- paclitaxel breast cancer patients treated at infusion centres willing to buy and staff the device, who have none of the listed contraindications and who tolerate the treatment; no share figure is asserted and no primary research supports one.
FTO (freedom to operate): no patent search was performed; the FTO field is unexamined. In particular no search was run on Paxman's patent position for limb cryocompression, on thermoelectric-cooled therapy garments, or on skin-temperature-servo cold therapy, all of which the Generator expects to be populated art.
jurisdiction: US — confidence: unverified — source: Generator's disclosure; verifiable as unexamined.
Assumption, not a fact: adults receiving weekly paclitaxel would tolerate hand and foot cooling and compression for the full duration of each infusion across a twelve-week course at a rate high enough for the device to deliver its intended effect.
Assumption, not a fact: infusion centres would accept the added chair time and nursing workload of fitting, monitoring and removing four wraps per patient per visit.
Mechanism and clinical-risk reasoning (Generator's own, flagged as reasoning rather than finding): the intended effect depends on sufficient distal vasoconstriction during peak drug exposure; named failure modes are cold injury or frostnip from control failure, pressure injury under compression, insufficient cooling at tolerable temperatures, reduced effect in patients with neuropathy risk from other causes (for example diabetes), and a theoretical concern about reduced drug exposure to occult disease in the cooled limbs. None has been characterized for this device because it does not exist.
jurisdiction: US — confidence: unverified — source: Generator's reasoning.
Assumption, not a fact: closing the loop on measured skin temperature would improve tolerability relative to uncontrolled frozen garments without losing the protective effect; no data for this device or its control strategy exist.
jurisdiction: US — confidence: unverified — source: Generator's assumption.
No device of this candidate's design exists as a prototype, and no bench, animal or human data exist for it; every performance property attributed to it in this file is design intent.
jurisdiction: US — confidence: unverified — source: Generator's own disclosure.
Competitive position: Paxman and Dignitana both market scalp-cooling systems into US infusion centres, and Paxman is developing the direct limb-cryocompression competitor to this candidate (claims 2-3); the Generator believes Paxman's scalp cooling system is FDA-cleared by 510(k) but did not identify a K-number.
jurisdiction: US — confidence: unverified — source: found via web search and Generator's recollection, not primary-source confirmed.
No domain dossier exists in this repo for chemotherapy-induced peripheral neuropathy or oncology supportive care: the knowledge-base/domains directory as of 2026-09-28 holds README.md, _template.md and twelve dossiers on other clinical areas.
jurisdiction: US — confidence: unverified — source: Generator's directory listing of knowledge-base/domains on 2026-09-28.
Words on this page15 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
CIPN
chemotherapy-induced peripheral neuropathy — nerve damage in the hands and feet caused by chemotherapy
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
CPT
Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
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
DEN######
an FDA De Novo decision number — the public record of one device granted a De Novo
FDA
US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
FTO
freedom to operate — whether a product can be sold without infringing someone else's live patent
HCPCS
Healthcare Common Procedure Coding System — the US billing codes for equipment, supplies and some services; a code is how a payer recognises what to pay for
NCT########
a ClinicalTrials.gov registration number — the public id of one registered clinical trial
PMID
PubMed identifier — the public id of one published medical paper
TAM
total addressable market — how much money the whole market would be worth if every possible buyer bought