Research & Clinical Evidence

Proven, not promised. Open the evidence.

Every TITN device is mapped to its FDA regulatory tier, its CMS-billable codes, and the peer-reviewed literature behind it. The 510(k) records, CPT and LCD references, and DOIs are all linked below. Credibility you can check, not claims you have to trust.

Sources verified: June 10, 2026 · Next review: June 10, 2027
Diagnostic Platform 01

WAVi Scan System (EEG/ERP)

FDA 510(k) cleared aid-in-diagnosis EEG and event-related potential platform. Used for cognitive screening, concussion baseline and management, ADHD assessment, and longitudinal brain monitoring.

FDA Clearance & Reimbursement
WAVi Co, Inc. · Class II medical device
510(k) cleared
FDA 510(k) record
K213900 · WAVi SCAN software, indicated for acquisition, display, and storage of EEG and event-related potentials to aid in diagnosis.
View FDA 510(k) record →
Reimbursable CPT codes
  • 95999 · Unlisted neurological or neuromuscular diagnostic procedure for an EEG plus ERP panel device, billed as one unit and not unbundled to component codes; unlisted codes are priced by report and confirmed with the payer before service
  • 99483 · Cognitive assessment and care plan visit (directional Medicare $260 to $282, once per 180 days)
  • Component codes (95816 routine EEG, 95957 digital EEG analysis, 95930 VEP) only where a separate test is independently performed, documented, and payer-recognized

Rates per CMS Physician Fee Schedule. Verify locality via the CMS PFS Look-Up. Coverage and reimbursement vary by payer.

Indications for use (verbatim)
"The WAVi SCAN software is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) to aid in diagnosis."
Source: WAVi Scan Manual IFU (PDF) →
Peer-reviewed clinical context
Foundational EEG and ERP literature
What TITN claims: WAVi captures EEG and ERP data to aid in clinical diagnosis. Reimbursable under the listed CPT codes when documentation supports medical necessity.
What TITN does not claim: WAVi does not diagnose Alzheimer's, dementia, concussion, or TBI as a standalone test. Interpretation remains the clinician's responsibility. The withdrawn K162460 Research Desktop variant is not marketed.
Diagnostic Platform 02

TM-Flow System (ANS, SUDO, ABI)

Three-module integrated workstation, each module independently FDA 510(k) cleared. Manufactured by LD Technology. Covers autonomic function, sudomotor activity, and ankle-brachial index in one ten-minute session.

Three FDA 510(k) clearances
LD Technology, LLC · Class II medical device
510(k) × 3
Module 1 · TBL-ABI (vascular)
K173696 · Ankle-brachial index, pulse volume recording, plethysmography for PAD screening.
View FDA record → · Manufacturer announcement
Module 2 · SudoC (sudomotor)
K152216 · Galvanic skin response for sudomotor / sweat gland function assessment.
View FDA record →
Module 3 · Oxi-W (HRV / PPG / endothelial)
K200141 · SpO2, pulse rate, photoplethysmography waveform analysis, HRV, endothelial function analysis.
View FDA record →
Reimbursable CPT codes
  • 95921 · Cardiovagal innervation testing
  • 95922 · Vasomotor adrenergic testing
  • 95923 · Sudomotor (QSART, SSP) testing
  • 95924 · Combined parasympathetic / sympathetic with tilt
  • 93922 · Limited bilateral arterial physiologic studies
  • 93923 · Complete bilateral arterial physiologic studies

Coverage criteria per CMS LCD A57651 and A57551. Documentation must support medical necessity.

Peer-reviewed clinical context
Autonomic neuropathy + PAD literature
What TITN claims: TM-Flow integrates three independently cleared modules. It supports PAD screening, sudomotor function measurement, and autonomic function assessment per the cleared indications of each module.
What TITN does not claim: TM-Flow does not diagnose diabetic neuropathy as a standalone test. The field nickname "ANS+" is informal and is not used in regulated marketing; the FDA-recognized name is TM-Flow. Reimbursement is not guaranteed; LCD coverage criteria must be met.
Diagnostic Platform 03

Max Pulse (Cardiovascular)

Pulse-wave cardiovascular and arterial stiffness screening at chairside. Three-to-five-minute test, immediate report.

Regulatory status
Cash-pay screening positioning
FDA 510(k) K110374
US FDA 510(k) status
The Max Pulse is cleared under FDA 510(k) K110374. TITN positions it as a cash-pay cardiovascular wellness screening; any insurance billing must be payer-confirmed.
What TITN claims: Fast chairside pulse-wave screening tool for cardiovascular and arterial stiffness signals, useful as part of a longitudinal wellness program.
What TITN does not claim: Max Pulse is a cash-pay screening tool, not a replacement for a formal cardiac diagnostic workup. Insurance billing must be payer-confirmed.
General pulse-wave research
Foundational arterial stiffness literature

Pulse-wave analysis as a vascular biomarker rests on a substantial peer-reviewed evidence base, independent of any single device. Aortic pulse wave velocity and augmentation index are well-characterized markers of arterial stiffness in the cardiology literature. We cite the device by its FDA 510(k) number (K110374) and do not claim device-specific validation studies beyond what the manufacturer or independent investigators have published.

Treatment Platform 01

ALTMS / BLOSSOM TMS

FDA 510(k) cleared rTMS therapy for adults with Major Depressive Disorder who have failed prior antidepressants. Reimbursable through a full treatment course under TMS CPT codes.

FDA Clearance & Reimbursement
REMED Co Ltd · Class II medical device
510(k) cleared
FDA 510(k) record
K220625 · ALTMS / BLOSSOM TMS, repetitive transcranial magnetic stimulation indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
View FDA 510(k) record →
Reimbursable CPT codes
  • 90867 · TMS, initial, with cortical mapping, motor threshold, delivery, management
  • 90868 · TMS, subsequent delivery and management
  • 90869 · TMS, subsequent motor threshold re-determination with delivery

Coverage criteria per CMS LCD L34998 and billing article A57072.

Peer-reviewed clinical evidence
TMS for MDD pivotal trials and consensus
What TITN claims: ALTMS is cleared for adults with treatment-resistant Major Depressive Disorder. Reimbursable through the listed TMS CPT codes when LCD criteria are met.
What TITN does not claim: US marketing of ALTMS does not extend to epilepsy, OCD, Parkinson's, tinnitus, MS, panic, or hallucinations, even where those indications appear in the Korean IFU.
Treatment Platform 02 · General Wellness

Hue Light USA Suite (BAHI Protocol)

The Hue Light USA suite operates exclusively under the FDA General Wellness policy for low-risk devices. These products are not FDA cleared. The peer-reviewed citations below describe the underlying mechanism research for each modality; they are not Hue Light-specific clinical claims.

PBM Bed (Photobiomodulation)
38,880 LEDs · 530 / 660 / 850 / 940 nm
General Wellness
Mechanism research
What TITN does not claim for the PBM Bed: Therapy modality CPT codes (e.g., 97026, 97039), pain relief indications belonging to other manufacturers' cleared devices, or fat-loss / body-contouring claims. Cash-pay only.
H-2000 (Molecular Hydrogen)
Hydrogen inhalation device
General Wellness
Mechanism research
What TITN does not claim for H-2000: Treatment of COPD, inflammatory conditions, metabolic syndrome, or any disease indication. Wellness and relaxation positioning only. Cash-pay only.
H-Bot (Hyperbaric Chamber)
Cash-pay relaxation chamber
General Wellness
Clinical HBOT reference (separate domain)
  • Weaver LK (ed). (2019). Hyperbaric Oxygen Therapy Indications, 14th Edition. UHMS.
    uhms.org
  • Huang ET, et al. (2015). A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers. Undersea Hyperb Med.
    PubMed 26152105
What TITN does not claim for H-Bot: Clinical HBOT billing under NCD 20.29 codes (G0277, 99183, C1300) does not apply to H-Bot. No wound-care, autism, stroke, Lyme, cancer, or TBI claims. The cited HBOT literature applies to therapeutic-pressure clinical HBOT in FDA-cleared chambers, not to H-Bot.
Hue Light Wave Motion (WME-01)
Whole-body vibration platform
General Wellness
Mechanism research
What TITN does not claim for Wave Motion: Therapy modality CPT codes (97026, 97039), pain relief indications belonging to other manufacturers' cleared devices, or fat-loss / body-contouring claims.
Diagnostic Platform 04 · Molecular

Genetic Panels via PreCheckHealth

Clinical-grade genetic testing delivered by PreCheckHealth Services. Four provider-ordered panels covering pharmacogenomics, hereditary cancer, immunogenetics, and adult neurogenetics.

Lab Accreditation
PreCheckHealth Services · provider-ordered only
CLIA + CAP
CLIA certification
10D2210020 · Clinical Laboratory Improvement Amendments certified for high-complexity testing.
PreCheckHealth →
CAP accreditation
9101993 · College of American Pathologists accredited laboratory.
Four available panels
  • PharmacoCheck+ · Pharmacogenomics; drug-metabolizing enzyme variants for personalized medication selection
  • CancerCheck · 116-gene hereditary cancer panel covering solid tumors, hematologic malignancies, and multi-system syndromes
  • ImmunoCheck · 291-gene immunogenetic panel for inborn errors of immunity, dysregulated inflammation, autoimmune predisposition
  • Comprehensive Neurogenetic Panel · 203-gene adult panel covering epilepsy, neuromuscular, leukodystrophies, hereditary neuropathies, neurodegenerative
Clinical context
How TITN positions the genetic layer

All four panels are provider-ordered through PreCheckHealth and delivered with virtual genetic counseling. PreCheckHealth bills insurance directly; TITN serves as a referral partner. The genetic data integrates with TITN's WAVi and TM-Flow records on the HIPAA-compliant patient portal.

Pharmacogenomics pairs cleanly with ALTMS treatment planning (psychiatric medication metabolism). The Neurogenetic Panel pairs with WAVi for genetic-plus-functional baseline assessment.

What TITN claims: PreCheckHealth panels are CLIA-certified and CAP-accredited clinical diagnostics, provider-ordered, with virtual counseling included.
What TITN does not claim: Consumer SNP testing, ancestry analysis, or wellness positioning. These are clinical panels ordered by a physician for clinical use.
Compliance & Transparency

How we back what we publish.

Every claim on this page traces to one of these source tiers. Estimates and "directional" data are marked. If a claim cannot trace to a source, it is not on this page.

Tier 1 · Government & primary literature

FDA 510(k) database (accessdata.fda.gov), CMS Physician Fee Schedule (PFS Look-Up), CMS Coverage Database (LCDs, NCDs, articles), peer-reviewed citations via PubMed and DOI.

Tier 2 · Manufacturer technical documentation

Device IFUs, manufacturer regulatory pages (LD Technology, WAVi Co, REMED), Hue Light USA technical specifications. Used for device specs, not for clinical efficacy claims.

What we do not claim

The TITN Forbidden Claims sheet lives in our internal regulatory documentation. Highlights are surfaced under each device above. Examples: WAVi does not "diagnose" Alzheimer's, TM-Flow modules are cited individually by K-number rather than collapsed, Hue Light products operate exclusively under General Wellness scope.

Reimbursement disclaimer

Listed CPT codes and Medicare PFS rates are reference points only. Actual reimbursement varies by payer, plan, locality, and patient eligibility. CMS-published rates change annually. Verify locality-specific rates via the CMS PFS Look-Up before billing.

All Sources

Every URL on this page, in one list.

Live as of June 10, 2026. Next scheduled review: June 10, 2027. Spot a broken or outdated link? Email roberto@transitionitnow.com.

CMS coverage & reimbursement

  1. CMS Physician Fee Schedule Look-Up
  2. CPT 95999 (unlisted neurological procedure) for the EEG/ERP panel: priced by report, billed as one unit and not unbundled, confirmed with the payer before service
  3. LCD L34998 · TMS for MDD
  4. A57072 · TMS billing and coding
  5. A57651 · Autonomic Function Tests
  6. A57551 · Autonomic Function Testing
  7. NCD 20.29 · Hyperbaric Oxygen Therapy

Genetic panels · PreCheckHealth

  1. PreCheckHealth Services · home
  2. CLIA certification 10D2210020 · College of American Pathologists accreditation 9101993 (verifiable via CMS CLIA Look-Up and CAP directory).

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