Is Lumius profitable in 2026?

No. Lumius is pre-revenue as of July 2026, still building a working prototype with no disclosed customers, pricing, or FDA clearance, per its own YC job listing and company page dated 2026-07-01 and 2026-06-09.

Has Lumius received FDA clearance for its 3D ultrasound device?

No. As of the 2026-05-08 Launch YC post, Lumius was still explicitly seeking feedback on FDA regulatory pathways, and no clearance or filing for the device has been found in public sources through July 2026.

Who founded Lumius and where is it based?

Lumius was founded by three PhDs from Duke University's Biomedical Engineering ultrasound and photoacoustic-imaging program, including named co-founders Luca Menozzi and Chenhang Li; the company is based in Durham, NC, per its YC page dated 2026-06-09.

How many employees does Lumius have?

Lumius has approximately 4 employees, consistent across YC directory crawls on 2026-07-11 and 2026-07-25, making it a very small, early founding team still actively hiring hardware engineers.

Who is Lumius's biggest competitor?

Clarius is the most direct near-term threat: it already ships AI-guidance software like Needle Enhance on cheaper 2D handheld ultrasound devices as of 2026-06-01, potentially closing the ease-of-use gap Lumius's 3D hardware is meant to solve before Lumius ships.

Could AI replace what Lumius is building?

Not the hardware itself, but AI-guided 2D needle-tracking software from Clarius and Butterfly, already shipped as of 2026, could substitute for Lumius's core de-skilling value proposition before Lumius's 3D device reaches clinics.

YC Spring 2026 · United States

Lumius

Lumius builds a low-cost 3D ultrasound to guide central-line placement.

Losing its protection

Assessed 27 July 2026 · Evidence as of 27 July 2026

The structural protection is eroding.

On the recordSince 27 July 2026 · Checkable from H2 2027 · Every call on the record Checkpoint: Planned FDA 510(k) filing for the vascular-access indication

The call

Lumius has a real clinical problem to solve but no cleared device, no published trial data, and a cheaper AI-guided 2D rival already on the market.

Lumius builds 3D ultrasound devices to help doctors place central lines (tubes into large veins) on the first try, which currently fails about half the time. The problem is real and serious, but Lumius has not yet won FDA approval, proven its 3D technology works better than simpler alternatives, or shown it can compete on price and ease of use. The immediate threat is companies like Clarius that are already selling AI-guided 2D ultrasound (simpler, cheaper, works on devices hospitals already own) that could solve the same problem well enough before Lumius finishes building and testing its 3D system. The one thing that could change everything is clinical data proving that 3D ultrasound cuts failure rates so much more than AI-guided 2D that hospitals will wait for Lumius and pay more for it.

Why

AI pressure: Clarius Needle Enhance (AI-guided 2D needle tracking). Clarius already sells AI guidance on cheap 2D handhelds, closing the same novice-skill gap Lumius wants to own with 3D. Could AI do the core job? Only partly.

Bigger players: Butterfly Network, GE HealthCare, Philips. These larger handheld ultrasound makers could bolt on similar AI guidance or 3D features once Lumius proves demand. Could a giant copy it? Yes, easily.

What protects it. Being first to ship real-time 3D volumetric guidance cheaply, but this is unproven, unpatented, and unfiled with the FDA.

What would change this call

Lumius files for or receives FDA clearance for its 3D vascular-access device within 12-18 months. Shows whether Lumius can turn its hardware prototype into a sellable regulated product.
Clarius, Butterfly, or Exo announce expanded AI needle-guidance features for central-line placement. Shows the 2D incumbents closing the ease-of-use gap before Lumius ships its 3D device.
Lumius publishes clinical trial data comparing 3D imaging to AI-guided 2D on first-attempt success rate. Would show whether Lumius's core clinical claim actually beats existing cheaper alternatives.

Key numbers

About 4 employees at Lumius (2026-07-25)
No FDA clearance found for the device (2026-07-25)
Central-line first-attempt failure rate near 50% for novices (2026-06-09)

Named risks

No FDA clearance filed for vascular-access device as of mid-2026. Severity: high
Core de-skilling value prop already partly addressed by shipped AI-on-2D features from Clarius and Butterfly. Severity: high
No confirmed patents or proprietary transducer IP disclosed publicly. Severity: medium
Only about 4 employees and no disclosed funding amount beyond standard YC investment. Severity: medium
No public revenue, customers, or clinical trial data to validate 3D-vs-AI-2D outcomes. Severity: medium

Rivals, as read in July 2026

Rival	Direction	Evidence
Clarius	gaining on	Ships AI needle-guidance and organ-specific AI presets on 2D handhelds as of 2026-06-01
Butterfly Network	contesting	CMUT-on-chip architecture positioned as path to affordable 3D, per 2026-06-26 analysis
Siemens Healthineers	contesting	Markets AcuNav Lumos 3D/4D cardiovascular catheter ultrasound imaging as of 2026-07-01
iSono Health	contesting	YC-backed 3D plus AI handheld ultrasound peer, ~9 employees, breast screening focus, 2026-07-25
GE HealthCare, Philips	contesting	Established handheld ultrasound lines (Vscan Air, Lumify) with no structural barrier to entering niche

Questions people ask

Is Lumius profitable in 2026?: No. Lumius is pre-revenue as of July 2026, still building a working prototype with no disclosed customers, pricing, or FDA clearance, per its own YC job listing and company page dated 2026-07-01 and 2026-06-09.
Has Lumius received FDA clearance for its 3D ultrasound device?: No. As of the 2026-05-08 Launch YC post, Lumius was still explicitly seeking feedback on FDA regulatory pathways, and no clearance or filing for the device has been found in public sources through July 2026.
Who founded Lumius and where is it based?: Lumius was founded by three PhDs from Duke University's Biomedical Engineering ultrasound and photoacoustic-imaging program, including named co-founders Luca Menozzi and Chenhang Li; the company is based in Durham, NC, per its YC page dated 2026-06-09.
How many employees does Lumius have?: Lumius has approximately 4 employees, consistent across YC directory crawls on 2026-07-11 and 2026-07-25, making it a very small, early founding team still actively hiring hardware engineers.
Who is Lumius's biggest competitor?: Clarius is the most direct near-term threat: it already ships AI-guidance software like Needle Enhance on cheaper 2D handheld ultrasound devices as of 2026-06-01, potentially closing the ease-of-use gap Lumius's 3D hardware is meant to solve before Lumius ships.
Could AI replace what Lumius is building?: Not the hardware itself, but AI-guided 2D needle-tracking software from Clarius and Butterfly, already shipped as of 2026, could substitute for Lumius's core de-skilling value proposition before Lumius's 3D device reaches clinics.

Timeline

2026-07-25YC directory lists Lumius at 4 employees, unchanged from July 11 crawl
2026-07-01Lumius posts Hardware & Embedded Engineer role, $80K-$110K base plus equity
2026-06-09YC company page details Lumius product, team, and vascular-access wedge
2026-05-08Launch YC post for Lumius published, seeking FDA pathway feedback
2026-03Estimated Lumius public launch on YC Launch platform (inferred from May post)
2024-09-06Duke BME profiles the ultrasound research trio behind Lumius's founding team

Revision history

27 July 2026

First assessed. Losing its protection. The text above is fixed as of this date and is not edited afterwards.

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