Companies / Elucent Medical

Medical device company profile

Elucent Medical

Surgical navigation and soft-tissue localization using the EnVisio platform and SmartClip markers.

Medical Device ManufacturerOncologyCommercial-stage

Headquarters🇺🇸Eden Prairie, Minnesota, United States

FoundedNot confirmed

Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.

EmployeesNot confirmed

Estimated revenueNot confirmed

Disclosed fundingUS$42.5 million ^[20]Series C · Apr 2024

Official websiteelucent.com ↗

Company overview

Elucent Medical develops localization and navigation technology for soft-tissue surgery. Its EnVisio system combines implanted SmartClip markers, sensors and spatial positioning to help surgeons locate target tissue with existing surgical instruments. The company operates from Eden Prairie, Minnesota.

Commercial adoption is documented through manufacturer announcements and named physician accounts. In July 2025 the company reported that EnVisio had supported more than 25,000 procedures. That is a dated manufacturer-reported utilization milestone, rather than an independently audited installed-base or outcomes measure.

The portfolio includes an established navigation platform and marker technology alongside newer development work. FDA records also document a recall involving the EnVisio Patient Pad Transition Cushion and compatibility with specified Skytron operating tables. The affected accessory and recorded restrictions are kept separate from a blanket assessment of the system.

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Leadership

3 people

Jason PesterfieldPresident & Chief Executive Officer ^[14]

Kirk JacquayChief Financial Officer ^[14]

Ryan DenneyChief Commercial Officer ^[14]

Products & regulatory status How does MedTechIndex get this information?

Summary

EnVisio and SmartClip have a 510(k) lineage that includes the original SmartClip soft-tissue marker decision K180640 as well as later system updates. EnVisio X1 development and company-reported Breakthrough designation are separate from the existing localization-system authorizations. ^{[12][16][17][18][19][2][15][1]}

The matched FDA history contains 1 distinct recall event: 1 open, 0 terminated. Z-0806-2025 (2024-11-18; open, classified): There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System. ^[9]

Regulatory snapshot How to read this snapshot

U.S. FDA

4
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 1
Recall events

Latest recorded source review: 2026-10-20.

View 1 documented open recall event

Documented open FDA recall events
Recalled product / record	Initiated	Source
EnVisio Patient Pad Transition CushionZ-0806-2025	November 18, 2024	^[9][19]

Commercial portfolio snapshot

Documented commercial product families.

Soft-tissue localization / surgical navigation

EnVisio Navigation System and SmartClip markers ↗

Spatial positioning platform with implanted localization markers and instrument-mounted sensing. ^{[12][16][17][18]}

FDA-cleared

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

Commercial development

The core localization portfolio is commercially offered. Newer EnVisio X1 and application-expansion claims require separate device-specific review; Breakthrough designation is not marketing clearance. ^[12]

Activity & Milestones

2 events

2026-05-14 · Regulatory

SmartClip delivery-catheter clearance

FDA recorded clearance of SmartClip Delivery Catheter ADR-1715. ^[18]

2025-07-31 · Commercialization

Company reports 25,000 EnVisio procedures

Manufacturer-reported cumulative utilization milestone; not a controlled clinical outcome or audited customer count. ^[13]

20 Cited Sources

Accessed 10/29/2026

[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record

[2] FDA K180640 — SmartClip Soft Tissue Marker ↗U.S. Food and Drug Administration · regulatory record

[3] FDA K183400 — EnVisio Navigation Sytem ↗U.S. Food and Drug Administration · regulatory record

[4] FDA K233639 — SmartClip Secure Soft Tissue Marker ↗U.S. Food and Drug Administration · regulatory record

[5] FDA K260565 — SmartClip Delivery Catheter (ADR-1715) ↗U.S. Food and Drug Administration · regulatory record

[6] FDA De Novo database — research search ↗FDA / openFDA · regulatory record

[7] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[8] FDA PMA database — research search ↗FDA / openFDA · regulatory record

[9] FDA recall Z-0806-2025 — Elucent Medical Inc ↗U.S. Food and Drug Administration · regulatory record

[10] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[11] FDA UDI database — research search ↗FDA / openFDA · regulatory record

[12] EnVisio platform and SmartClip overview ↗Elucent Medical · company website

[13] 25,000 procedures reported ↗Elucent Medical · company website · Published 2025-07-31

[14] Current leadership ↗Elucent Medical · company website

[15] Employer careers and active posting source ↗Elucent Medical · company website

[16] FDA 510(k) K183400 ↗U.S. Food and Drug Administration · regulatory database

[17] FDA 510(k) K233639 ↗U.S. Food and Drug Administration · regulatory database

[18] FDA 510(k) K260565 ↗U.S. Food and Drug Administration · regulatory database

[19] FDA recall Z-0806-2025 ↗U.S. Food and Drug Administration · regulatory database

[20] Elucent Medical announces US$42.5 million Series C ↗Elucent Medical · company announcement