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Companies / ImpediMed
Medical device company profile

ImpediMed

Bioimpedance spectroscopy platform for fluid-status, lymphedema and body-composition assessment.

Medical Device ManufacturerCardiovascular & VascularDiagnostics & ImagingLymphatic & Venous CarePhysiological AssessmentCommercial-stage
Headquarters🇦🇺Australia
FoundedNot confirmed
Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.
EmployeesNot confirmed
Estimated revenueNot confirmed
Disclosed fundingUS$15 million [34]Growth-capital facility · Feb 2025
Official websitewww.impedimed.com ↗

Company overview

ImpediMed develops the SOZO Digital Health Platform, combining bioimpedance spectroscopy devices with MySOZO software. The system measures electrical properties of the body to support clinicians assessing fluid status and body composition, with applications in cancer survivorship, lymphedema surveillance and heart health.

Its portfolio includes SOZO and SOZO Pro. FDA records document device-specific decisions and an August 2026 MySOZO software clearance; the company announced sarcopenia-risk functionality for an upcoming release. Clearance and a planned software rollout are distinct milestones.

Erik Anderson became Managing Director and CEO in April 2026. The company has Australian corporate roots and U.S. operations in Carlsbad. A reviewed FDA recall remains open for specified older bilateral-arm L-Dex software; it is not generalized to every current SOZO assessment or software version.

[31][32][33][34][35][36]

Leadership

3 people
Erik AndersonManaging Director & Chief Executive Officer [32]
McGregor GrantExecutive Director & Chief Financial Officer [32]
Scott SavageChief Product Officer [32]

Products & regulatory status How does MedTechIndex get this information?

Summary

SOZO, SOZO Pro and MySOZO have a longer 510(k) history than the earlier snapshot showed, including MySOZO software K253224. Indications differ between fluid assessment, body composition and later functions. Historical L-Dex products and the bilateral-arm software recall must be distinguished from current software versions. [35][28][29][17][33][1]

The matched FDA history contains 1 distinct recall event: 1 open, 0 terminated. Z-0155-2024 (2023-08-17; open, classified): Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention. [22]

Regulatory snapshot How to read this snapshot

U.S. FDA
11
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

View 1 documented open recall event

Includes open events outside the mapped current portfolio; those events are excluded from the snapshot count.

Documented open FDA recall events
Recalled product / recordInitiatedSource
  • SOZO Bilateral Arm L-Dex SoftwareZ-0155-2024
August 17, 2023[22][29]

Commercial portfolio snapshot

Documented commercial product families.

Bioimpedance spectroscopy analyzer

SOZO / SOZO Pro ↗

Connected BIS platform for device-specific fluid and body-composition assessments. [35][25][26][27]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Clinical assessment software

MySOZO software ↗

Cloud-based software used with compatible SOZO devices; August 2026 clearance documented separately from planned release timing. [35][28]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Products with unconfirmed commercial availability

Legacy assessment software

Legacy bilateral-arm L-Dex software v4.1 / v5.0 ↗

Specified bilateral-arm assessment versions subject to a 2023 correction. [35]

Commercial availability not established

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Commercial development

Product-specific clearance and rollout timing are kept distinct. Historical software recall remains visible without attributing it to all current configurations. [35][28][29]

Activity & Milestones

2 events
2026-08-17 · Regulatory

MySOZO software cleared

FDA recorded K260224 on August 17, preceding the company announcement. [28]

2026-04-07 · Leadership

Erik Anderson appointed CEO

Company announced Anderson as Managing Director and CEO. [33]

36 Cited Sources

Accessed 10/29/2026

[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record
[2] FDA K050395 — IMPEDIMED - BODY COMPOSITION ANALYSIS ↗U.S. Food and Drug Administration · regulatory record
[3] FDA K050415 — IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS ↗U.S. Food and Drug Administration · regulatory record
[4] FDA K052319 — IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 ↗U.S. Food and Drug Administration · regulatory record
[5] FDA K080825 — IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 ↗U.S. Food and Drug Administration · regulatory record
[7] FDA K130338 — IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS ↗U.S. Food and Drug Administration · regulatory record
[8] FDA K172122 — SOZO ↗U.S. Food and Drug Administration · regulatory record
[9] FDA K172507 — SOZO ↗U.S. Food and Drug Administration · regulatory record
[10] FDA K180126 — SOZO ↗U.S. Food and Drug Administration · regulatory record
[11] FDA K190529 — SOZO ↗U.S. Food and Drug Administration · regulatory record
[12] FDA K193410 — SOZO Body Fluid Analyzer ↗U.S. Food and Drug Administration · regulatory record
[13] FDA K203473 — SOZO ↗U.S. Food and Drug Administration · regulatory record
[14] FDA K230530 — SOZO Pro ↗U.S. Food and Drug Administration · regulatory record
[15] FDA K230531 — SOZO Pro ↗U.S. Food and Drug Administration · regulatory record
[16] FDA K232089 — SOZO Pro ↗U.S. Food and Drug Administration · regulatory record
[17] FDA K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) ↗U.S. Food and Drug Administration · regulatory record
[18] FDA K260224 — MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) ↗U.S. Food and Drug Administration · regulatory record
[19] FDA De Novo database — research search ↗FDA / openFDA · regulatory record
[21] FDA PMA database — research search ↗FDA / openFDA · regulatory record
[22] FDA recall Z-0155-2024 — Impedimed Limited ↗U.S. Food and Drug Administration · regulatory record
[24] FDA UDI database — research search ↗FDA / openFDA · regulatory record
[25] FDA 510(k) K180126 ↗U.S. Food and Drug Administration · regulatory database
[26] FDA 510(k) K230530 ↗U.S. Food and Drug Administration · regulatory database
[27] FDA 510(k) K232089 ↗U.S. Food and Drug Administration · regulatory database
[28] FDA 510(k) K260224 ↗U.S. Food and Drug Administration · regulatory database
[29] FDA recall Z-0155-2024 ↗U.S. Food and Drug Administration · regulatory database
[31] Employer hiring source reviewed ↗ImpediMed · company website
[32] Current management team ↗ImpediMed · company website
[33] April 2026 CEO appointment ↗ImpediMed · company website
[35] SOZO and SOZO Pro platform ↗ImpediMed · company website
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