What Piccolo Medical does

Piccolo Medical is a San Francisco-based medical device company that developed catheter navigation and tip-confirmation technology for Peripherally Inserted Central Catheter (PICC) and central venous catheter (CVC) placement. Founded in 2016 as a spin-out of the Theranova medical device incubator, the company's core platform combines proprietary ionic dilution (blood-flow-based sensing) with intravascular ECG to enable real-time, bedside catheter tip positioning as a 510(k)-cleared alternative to confirmatory chest X-ray. Its product portfolio includes the PM2+ System, Nav+ Stylet, ECGuide Connector, and the original SmartPICC System (marketed as Nav+ in the U.S.), spanning adult, pediatric, and neonatal indications.

The company monetizes through hardware sales of capital equipment and disposable components to hospitals and healthcare providers, with pricing conducted via quote-based procurement. Go-to-market relied on direct enterprise field sales to hospitals alongside clinical research partnerships, then transitioned in January 2025 to an exclusive North American distribution agreement with Spectrum Vascular. Funding was raised through a combination of NIH grants (Phase II SBIR in 2018, $3M NIA CRP grant in 2024, NICHD pediatric funding) and equity capital (a $5.5M Series B led by Event Capital Strategies in October 2023).

In June 2026, Piccolo Medical was acquired by Spectrum Vascular (backed by SK Capital Partners), with CEO Augie Shanahan and the legacy team joining Spectrum to accelerate commercialization of next-generation catheter navigation products. At acquisition the company was privately held, headquartered in San Francisco, and operated with a team in the 1-10 employee range.

Name

Piccolo Medical

Legal name

Piccolo Medical, Inc.

Website

https://piccolomedical.com

Company type

Private

Founded year

2016

Operating status

Acquired

Headcount range

1–10 employees

Short description

Piccolo Medical is a San Francisco-based medical device company developing catheter navigation and tip-confirmation systems (PM2+, Nav+ Stylet, ECGuide) that use ionic dilution and intravascular ECG to enable bedside PICC and central venous catheter placement without confirmatory X-ray.

Ownership category

akta.pro rank

Product category

Vascular Access Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Vascular Access Devices (AV Grafts, Catheters, Fistula Accessories) (HLAHAKAE)

akta.pro secondary industries

Infusion Sets, Catheters & Pump Consumables (HLAHAIAH), Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL)

Keywords

• Catheter navigation systems
• PICC placement devices
• Intravascular ECG technology
• Vascular access medical devices
• Tip confirmation systems

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Catheter Navigation Hardware Systems: Sale of PM2+™ and PM2® Systems, Nav+™ Stylets, and ECGuide™ Connectors to hospitals and healthcare providers. The company sells medical devices that include capital equipment and disposable components.
2. SmartPICC® Product Line: Second-generation SmartPICC® Stylet and PM2+™ System for PICC placement. Revenue generated from the sale of these FDA-cleared catheter navigation devices.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Piccolo Medical develops and sells catheter navigation and tip confirmation medical devices for peripherally inserted central catheter (PICC) and central venous catheter placement. The portfolio includes the FDA 510(k)-cleared PM2+™ System, Nav+™ Stylet, and ECGuide® Connector, which use proprietary ionic dilution and intravascular ECG sensing to guide catheters from the insertion site to the superior vena cava and confirm tip position at the bedside as an alternative to chest x-ray.

Product overview

Piccolo Medical is a medical device company offering a portfolio of catheter navigation and tip confirmation products. The core portfolio includes the PM2+™ System (a 510(k)-cleared platform using intravascular ECG and proprietary ionic dilution technology), the Nav+™ Stylet (for PICC guidance), and ECGuide® (an intravascular ECG-based catheter guidance system cleared for adult, pediatric, and neonatal patients). The SmartPICC® System was the original product, now marketed as Nav+™ in the U.S. These products enable real-time bedside catheter tip confirmation as an alternative to chest X-ray, using proprietary blood flow sensing and cardiac electrical activity monitoring to guide catheter placement and reduce complications.

Differentiator

Problem solved

Functional benefit

Brands

• SmartPICC®: Catheter guidance technology system for PICC placement using ionic dilution and ECG technology, cleared by FDA as alternative to chest x-ray for bedside confirmation of PICC positioning.
• ECGuide™
• Nav+™
• PM2+™ System

Products and services

• PM2+™ System A 510(k)-cleared catheter navigation and tip confirmation platform that uses intravascular ECG and proprietary ionic dilution technology to guide PICC catheters from the insertion site to the superior vena cava and confirm tip positioning at bedside as an alternative to chest X-ray. Includes a machine learning-driven app that analyzes ionic dilution and ECG data streams.
• Nav+™ Stylet A catheter guidance stylet that pairs with the PM2+ System, using intravascular ECG and ionic dilution technology to help navigate PICCs and confirm tip position at bedside in under 90 seconds. Set up in under 90 seconds to eliminate the need for confirmatory chest x-rays.
• ECGuide® An intravascular ECG catheter guidance system that uses the patient's cardiac electrical activity to determine catheter tip position, 510(k) cleared as an alternative to chest x-ray. Compatible with PICC, CVC, ports, and hemodialysis catheters 1 French or larger via universal luer lock connection. Cleared for adult, pediatric, and neonatal patients.
• SmartPICC® System The original catheter guidance system providing real-time catheter tip location using both cardiac electrical activity and proprietary ionic dilution sensing technology, FDA 510(k) cleared as an alternative to chest x-ray. Marketed as Nav+™ in the United States. Protected by multiple U.S. and international patents.
• ECGuide® Pediatric and Neonatal Application An expanded indication of the ECGuide® catheter guidance system cleared for pediatric and neonatal patients, reducing radiation exposure for vulnerable populations during central venous access device placement.

Quantifiable outcome

• Over 3 million PICCs placed in the US per year; 50% of catheters are malpositioned when placed without guidance technology
• +6 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

Five partnerships are on record, tiered flagship and core.

• Spectrum VascularflagshipStrategic or Co-development Partner · 11 June 2026Spectrum Vascular, backed by SK Capital Partners, acquired Piccolo Medical to accelerate launch of next-generation catheter navigation technology. CEO Augustus Shanahan and the legacy Piccolo team joined Spectrum. The combined entity aims to integrate Piccolo's navigation technology with Spectrum's existing catheter portfolio and set a new standard of care in vascular access. First successful patient placements of next-generation Nav+ Stylet completed in May 2026.
• Spectrum VascularcoreChannel Partner/ Reseller/ Distributor · 13 January 2025Exclusive distribution agreement where Spectrum Vascular serves as sole distributor of Piccolo Medical catheter navigation and tip confirmation devices including ECGuide™ and SmartPICC® product lines. The partnership aimed to expand reach of innovative and cost-effective technologies ensuring broader access for vascular access professionals worldwide. Chris Yamamoto, Board Member of Spectrum Vascular and Managing Partner of Event Capital Strategies, shared enthusiasm for the partnership supporting innovative technologies.
• Theranova Medical Device IncubatorcoreOthersPiccolo Medical was spun out of the Theranova medical device incubator in San Francisco, CA. Theranova has spun out several other successful medical device companies with products in the US, EU and CN markets.
• National Institute on Aging (NIA)coreOthersNIH National Institute on Aging has funded Piccolo Medical through prestigious Phase I and II grant awards, including a $3 million CRP grant in 2024 for advancing SmartPICC® technology for aging population.
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)coreOthersNIH institute providing grant funding for pediatric and neonatal applications of Piccolo's catheter guidance technology, supporting FDA clearance expansion in November 2025.

Recent moves7 records

Expansion highlights5 records

Direct peers

• Becton Dickinson (BD): BD acquired C.R. Bard and now markets the Sherlock 3CG tip confirmation system, the dominant bedside catheter navigation technology competing directly with Piccolo's PM2+/SmartPICC and ECGuide products. Both companies target hospital PICC and CVC placement workflows.
• Teleflex: Teleflex markets the Arrow VPS G4 with TipTracker technology for catheter tip positioning, the closest direct competitor to Piccolo's intravascular ECG and ionic dilution platform. Both serve vascular access teams placing PICCs and central venous catheters.
• ICU Medical: ICU Medical acquired Smiths Medical and offers a portfolio of vascular access devices including catheter positioning products that overlap with Piccolo's hospital PICC/CVC navigation offering.
• AngioDynamics: AngioDynamics markets vascular access products including BioFlo PICCs and other catheter platforms used in the same hospital vascular access workflows targeted by Piccolo's catheter guidance technology.
• Merit Medical Systems: Merit Medical offers a broad portfolio of vascular access devices and accessories used during PICC and central venous catheter placement, overlapping with Piccolo's hospital customer base and catheter navigation use cases.

Broad incumbents

• Cook Medical: Cook Medical is a large privately held medical device company with an extensive vascular access and catheter portfolio serving many of the same hospital customers as Piccolo, though without a directly comparable tip confirmation system.
• Abbott: Abbott is a diversified medical device and diagnostics company with vascular and hospital-facing product lines, providing broad incumbent competition across the catheter placement workflow where Piccolo operates.
• Medtronic: Medtronic is a diversified medical device leader with vascular, hospital, and critical care product lines that overlap with the broader catheter management workflow where Piccolo's tip confirmation products are deployed.
• Penumbra: Penumbra operates in the vascular space with thrombectomy and other catheter-based products, addressing overlapping hospital vascular access customers though focused on different procedural indications.
• Edwards Lifesciences: Edwards Lifesciences is a vascular and cardiac-focused medical device company whose hemodynamic monitoring portfolio overlaps with the cath lab and vascular access customers Piccolo serves with its catheter guidance technology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds4 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Piccolo Medical