Research report
A research report is the sourced material a domain
dossier is synthesized from — generated on a plan and a cadence, one topic per file.
A report carries no confidence tags. Its bracketed markers say who might have
an incentive to shade a line; none of them says anyone checked it. To reach a score, a line has
to be drafted onto a candidate as unverified and pass the Verifier or the
Corroborator, like everything else.
Section market-players · Version 2026-09-01 · Cadence monthly · Evidence class mixed · Sources 8 · Supersedes none
Domain: neonatal-hyperbilirubinemia-home-phototherapy · Scope: Public primary sources via connectors, WebSearch and WebFetch, centered on FDA's phototherapy product code (LBI, 21 CFR 880.5700) 510(k) clearance and recall registries, ClinicalTrials.gov, and PubMed. Excludes CPT descriptors (AMA-licensed), veterinary datasets, fda.gov guidance documents and case law, anything behind an unset PATENTSVIEW_API_KEY, non-US/non-EU jurisdictions, and company financial/funding data such as SEC filings or private financing rounds — no source located this pass carried a resolvable registry identifier for any such figure.
Sourcing: Rests on FDA's own 510(k)/recall registry for product code LBI, two ClinicalTrials.gov records, one Federal Register document, and two peer-reviewed publications; every line is single-source by construction of a federal registry record or a single published study.
A fresh 2026-09-01 scan of FDA's phototherapy product code (LBI, 21 CFR 880.5700) returns the same ten 510(k) clearances and five terminated recalls the domain dossier's own 2026-08-27 scan found, with nothing new added between the two runs. One clearance in that set, Neomedlight's BiliCocoon Phototherapy System (K163526, decided 2017-10-06), does not appear in the domain dossier's market-player table; its own cleared indication already covers home use, and its decision date predates the two 2025-2026 wearable entrants the dossier does track. Outside the FDA-cleared set, two other device-development paths registered in ClinicalTrials.gov show opposite outcomes: a French light-emitting-fabric device has been open to enrollment since at least 2020 and remains listed RECRUITING more than five years past its own protocol's projected completion, with no matching US clearance found under that name; a University of Minnesota phototherapy-accelerator study was withdrawn by its funding organization before enrolling a single participant. The one entrant with an independently published outcome study, BiliCocoon, showed a lower bilirubin-reduction rate than overhead phototherapy in a Danish randomized trial. No company financial, funding-round, or ownership-change data was carried forward as a finding, because nothing located this pass carried a resolvable registry identifier rather than a manufacturer or trade-press claim.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
A fresh scan of FDA's phototherapy product code (LBI, 21 CFR 880.5700) run for this report on 2026-09-01 returns the same ten 510(k) clearances the domain dossier's 2026-08-27 scan found, spanning decision dates 2016-12-12 to 2026-01-15, and the same five terminated recalls, none initiated after 2019-12-11 [1][2]. One of the ten clearances has no row in the dossier's market- player table: K163526, the BiliCocoon Phototherapy System, applicant Neomedlight, decided 2017-10-06. Neomedlight's own 510(k) summary states the device's indication in terms close to the two 2025-2026 wearable entrants the dossier does track: "intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home" [3]. Its decision date, 2017-10-06, is roughly eight years earlier than BiliWrap's (2025-05-29) and SnugLit's (2026-01-15), the two entrants the dossier's own reference-products section treats as the newest home-labeled arrivals in this product code.
Outside the FDA-cleared set, one device shows a different market position: registered for clinical study but not found among any of the ten LBI clearances scanned [1]. BUBOLight, a light-emitting-fabric sleeping bag developed at Lille University Hospital, is registered as NCT04365998, a single-center, single-group feasibility and safety study of 4-hour phototherapy sessions in neonates at least 35 weeks' gestation [4]. Its 2021 protocol publication described 10-15 neonates as the planned sample and projected final results by the end of 2021 [5]. The registry's most recent update, 2025-12-23, still lists the trial as RECRUITING, with an enrollment target of 15 [sponsor-reported] and no results posted [4]. No device named BUBOLight appears among the ten LBI 510(k) clearances scanned for this report [1].
A second pipeline signal points the other way. NCT04021927, "Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy," sponsored by the University of Minnesota, registered a descriptive safety/efficacy study of a reflective phototherapy-ring device intended to redirect otherwise-unused light onto an infant's untreated skin. The registry's own stated reason for stopping, verbatim: "Study withdrawn by funding organization with no participants enrolled" [6]. No subsequent 510(k) or later trial record tied to this device description was located in this pass.
Neomedlight's BiliCocoon is the only device in this product code, cleared or pipeline, with an independently published clinical-outcome study located this pass. A randomized, open-label trial at three Danish neonatal units (n=83) found BiliCocoon's mean total-serum-bilirubin reduction over 24 hours, adjusted for baseline, was significantly lower than overhead LED phototherapy — 29% versus 38% (p<0.01) — and neonates treated in the BiliCocoon ran on average 0.70°C warmer (p<0.01), with hyperthermia the most common reason breastfeeding was interrupted during treatment [7]. This adds a device-specific number to the domain dossier's own finding that the home-phototherapy evidence base runs "very low" to "low" quality by its own meta-analyses' grading.
A Federal Register search for "phototherapy" documents published by FDA over the same ten-year window returns 13 documents; the only device-classification action among them addresses a different indication — a 2026 final rule classifying a phototherapy device for reducing the appearance of acute post-surgical incisions, a dermatologic use [8]. No classification, reclassification, or special-controls order specific to neonatal hyperbilirubinemia phototherapy was found in this window.
[1] openFDA device/510(k) scan, product_code=LBI, window 2016-09-04 to 2026-09-02 — FDA (queried 2026-09-01; accessed 2026-09-01). 10 records: K160745, K163526 (Neomedlight, dec. 2017-10-06), K170585, K172656, K182178, K190899, K200031, K210289, K243372, K251308 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm [federal-registry] [2] openFDA device/recall scan, product_code=LBI, window 2016-09-04 to 2026-09-02 — FDA (queried 2026-09-01; accessed 2026-09-01). 5 records: Z-0769-2017, Z-0770-2017, Z-1503-2017, Z-1924-2017, Z-0923-2020, none initiated after 2019-12-11 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [3] FDA 510(k) summary K163526 — BiliCocoon Phototherapy System, Neomedlight (decision 2017-10-06; accessed 2026-09-01). Indications for Use, verbatim: "intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home." K163526 — https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163526.pdf [federal-registry] [4] ClinicalTrials.gov NCT04365998 — "BUBOLight, a New Phototherapy Device for the Treatment of the Newborn's Jaundice," sponsor University Hospital, Lille (record last updated 2025-12-23; accessed 2026-09-01). Status RECRUITING, enrollment 15 (ESTIMATED), hasResults=false. NCT04365998 — https://clinicaltrials.gov/study/NCT04365998 [trial-registry] [5] "Phototherapy Using a Light-Emitting Fabric (BUBOLight) Device in the Treatment of Newborn Jaundice: Protocol for an Interventional Feasibility and Safety Study" — JMIR Research Protocols (published 2021-05-25; accessed 2026-09-01). PMID 34032584 — https://pubmed.ncbi.nlm.nih.gov/34032584/ [peer-reviewed] [6] ClinicalTrials.gov NCT04021927 — "Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy," sponsor University of Minnesota (record last updated 2021-02-23; accessed 2026-09-01). Status WITHDRAWN, enrollment 0 (ACTUAL), hasResults=false. NCT04021927 — https://clinicaltrials.gov/study/NCT04021927 [trial-registry] [7] "Comparison of BiliCocoon phototherapy with overhead phototherapy in hyperbilirubinemic neonates. A randomized clinical trial" — Pediatric Research (published 2025, month not given in the PubMed record; accessed 2026-09-01). PMID 39489832 — https://pubmed.ncbi.nlm.nih.gov/39489832/ [peer-reviewed] [8] "Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions" — Federal Register, Food and Drug Administration (published 2026-05-01; accessed 2026-09-01). FR Doc. 2026-08497 — https://www.federalregister.gov/documents/2026/05/01/2026-08497/medical-devices-general-and-plastic-surgery-devices-classification-of-the-phototherapy-device-for [federal-registry]
Well established: The LBI clearance count (10) and recall count (5), and the dates bounding both, are drawn directly from FDA's own registry and agree with the domain dossier's own scan run five days earlier — but a single registry queried twice is not two independent sources, so these counts are stated plainly as registry facts rather than marked, following the convention already used for registry data throughout this domain's research.
Thin: Every finding beyond the bare clearance/recall counts rests on one source apiece: Neomedlight's own 510(k) indication statement [3], the BUBOLight trial's registry entry and its own protocol paper [4][5], the University of Minnesota trial's registry entry [6], and one Danish randomized trial [7]. BUBOLight's enrollment figure is [sponsor-reported] because it is the sponsor's ESTIMATED target, not a count of anyone actually enrolled.
Rescoped from class 3: none in this report. Every finding here concerns what has already happened — a clearance, a withdrawal, a registered trial's status, a measured outcome — not a claim about what any company or clinician would do.
Out of scope: Company financial, funding-round, revenue, or ownership-change data (the kind the manifest row's "funding" and "launches" language points at) was sought through NIH RePORTER's research-funding-scan connector, which did return Small Business Innovation Research/Small Business Technology Transfer award records describing a home-use phototherapy device and a phototherapy-accelerator device, the latter with title wording close to NCT04021927 above. Those award records are not carried into section 4 or asserted as findings: an NIH project number does not match any pattern in this fleet's resolvable-identifier list (PMID, NCT, K-number, CFR section, HCPCS code, DOI, CELEX, or FR Doc number), the same disqualification the task brief already names for an SEC EDGAR accession number. SEC filings themselves were not sought, for the same reason.
Not searched vs. not found: A name-specific NIH RePORTER search for "SnugLit" and for "Gerium" — the two most recently cleared entrants named in the domain dossier's market-player table — returned zero matching awards: searched, not found. Whether Neomedlight, Little Sparrows Technologies, Bistos, or Avalon Biomedical have since exited, merged, or ceased phototherapy- device operations was not searched this pass; FDA's clearance and recall registries carry no "still operating" field, and no business-registration or dissolution registry was queried. MAUDE adverse-event narratives for any named device in this product code were not searched, consistent with the domain dossier's own disclosed gap.
[inference] none. Every comparative statement in section 3 (earlier decision date, absence from a named list, a lower measured percentage) restates a direct comparison of dates, names, or numbers already quoted from a cited source, rather than an added interpretation of intent, causation, or what any party would do.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| FDA cleared Neomedlight's BiliCocoon Phototherapy System (K163526) on 2017-10-06 under product code LBI, indicated for neonates and infants under 3 months old weighing less than 10 kg, usable in the clinical setting or at home. | 1 registry | K163526 | 5. Reference products |
| ClinicalTrials.gov NCT04365998 (BUBOLight, University Hospital, Lille) remained status RECRUITING at its most recent registry update (2025-12-23), with no results posted. | 1 registry | NCT04365998 | 8. Market players & dynamics |
| ClinicalTrials.gov NCT04021927, a University of Minnesota phototherapy-accelerator study, was withdrawn by its funding organization with zero participants enrolled. | 1 registry | NCT04021927 | 8. Market players & dynamics |
| A randomized trial at three Danish neonatal units (n=83) found BiliCocoon's adjusted mean total-serum-bilirubin reduction over 24 hours (29%) was significantly lower than overhead LED phototherapy (38%, p<0.01). | 2 published | PMID 39489832 | 5. Reference products |
| FDA's LBI product-code 510(k) clearance count for the window 2016-09-04 to 2026-09-02 is 10, and the recall count for the same window is 5, with none initiated after 2019-12-11. | 1 registry | K251308 | 8. Market players & dynamics |