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Thimble Dx

Sources

Sources

Research for this project ran on November 4, 2026. Links are grouped by the document section they support. Where a figure differs between sources, the documents give the range or say which source they follow.

Theranos: timeline, technology, fraud, money

Haemanthus and Raman spectroscopy

Capillary versus venous blood

Multi-category instruments

Truvian: FDA clearance for TruVerus, Medtech Insight: launch in H2 2026, MassDevice: Truvian and Siemens Healthineers, San Diego Business Journal, Tracxn funding, PitchBook
360Dx: Genalyte TSH 510(k), Clinical Chemistry abstract A-380, Genalyte at ADLM 2025, FDA K191085, PMC: Maverick serology evaluation
biosurfit company history, FIND immunoassay platform landscape (2025), spinit CRP at MEDICA 2025, MTEC profile
PMC: LABGEO PT10 evaluation, Samsung discontinuation notice
Roche closes the LumiraDx acquisition, MedTech Dive: Roche to buy LumiraDx technology, LumiraDx Form D filings, PitchBook: LumiraDx, Wikipedia: Ron Zwanziger
Baebies: dual 510(k) and CLIA waiver for flu and COVID PCR, Baebies: anti-Xa Breakthrough designation, Baebies: G6PD 510(k)
360Dx: bioMérieux acquires SpinChip, Pathology in Practice: SPINCHIP launch
Siemens Healthineers: Atellica VTLi, PLAyEUS trial methods, VTLi clinical evidence
Wikipedia: Abionic, ADLM: Abionic CE marks
Nanomix whole-blood CE mark, 360Dx: Nanomix commercial plans
ProciseDx: FDA clearance of instrument and CRP, FDA K201256, Fierce Biotech: 5-minute drug-level tests
OPKO: Sangia PSA approval, FDA PMA P170037 summary, Phys.org: mChip

Hematology from a drop

Home devices and kiosks

Collection plus central lab

Consumer lab services

Molecular point of care

Continuous monitoring (the 2003 vision)

Low-resource and academic work

Retail health

Market, reimbursement and sites

Regulation

FDA Law Blog: court vacates the LDT rule, Federal Register: implementation of the vacatur (September 19, 2025)
FDA: CLIA Waiver by Application, FDA guidance: dual 510(k) and CLIA waiver studies, Pure Global: 510(k) review clocks and dual-track timing, MedDevice Guide: waiver strategy
Westgard: CLIA acceptance limits in force from 2025, Bio-Rad: CLIA 2024 limits
McDermott: CMS updates lab personnel requirements, QBench: CLIA certification guide, ScienceInsights: getting a CLIA number
Referenced without links: FDA's Quality Management System Regulation (effective February 2, 2026), section 524B of the Federal Food, Drug, and Cosmetic Act, FDA's guidance on predetermined change control plans for AI-enabled device software, SEC Rule 21F-17, 42 CFR 493 (CLIA), 21 CFR 862.1675, Washington's My Health My Data Act, and CLSI documents EP05, EP06, EP07, EP09, EP15, EP17, EP25, EP28 and GP42.

Bench starter

HunStat2 on GitHub and paper (Analytical Methods, 2025), HELPStat (ACS Electrochemistry), FreiStat for AD5940/AD5941
IO Rodeo: Zimmer and Peacock 501 carbon electrodes, ZP glucose sensors and Sensit Smart, ZP buy-and-try pricing
OpenFlexure blood imaging autofocus (arXiv), Robotic microscopy for everyone (bioRxiv), OpenFlexure_Cell_Counter, Mini-hematology-lab, OpenFlexure malaria study
OpenDrop digital microfluidics
Bioengineering (2025): paper glucose with plasma separation and a smartphone, Sensors (2024): label-printer paper device, Pall Vivid plasma separation datasheet, Analytica Chimica Acta (2025): dual-gradient membranes, PMC: 3D-printed plasma separation
Microsystems and Nanoengineering (2025): low-cost optical sensors in lab-on-a-disc, PLOS ONE (2022): open-source 3D-printed centrifuge adaptor, PMC: lab-on-a-disc separation with gel
Microsystems and Nanoengineering (2024): impedance cytometry leukocyte differential, Biosensors (2025): electrical blood counts review
Zander R, Lang W, Wolf HU. Alkaline haematin D-575, a new tool for the determination of haemoglobin as an alternative to the cyanhaemiglobin method. Clinica Chimica Acta, 1984.

One drop, many tests