Flat Medical

What Flat Medical does

Flat Medical Co. Ltd. is a Taiwan-headquartered medtech company that develops safety technology solutions for needle-based clinical procedures, primarily in anesthesia, pain medicine, critical care, and emergency medicine. The company's core technology is a pressure-sensing syringe platform that replaces subjective hand-feedback techniques with objective visual indicators for needle tip localization. Its flagship product, the EpiFaith Smart Syringe, provides real-time visual confirmation of epidural space entry to reduce accidental dural punctures, while the EpiFaith CV variant extends this pressure-sensing architecture to central venous catheterization with an arterial-puncture warning system above 30 mmHg and a guidewire safety lock. The product portfolio was expanded in September 2024 through the acquisition of IQ-Tip, an FDA Breakthrough Device Designation smart needle system using bioimpedance-based tissue recognition technology from InjeQ.

The company operates through three regional entities: Flat Medical Co. Ltd. (Taipei, Taiwan), FlatTech LLC (Austin, Texas, North American headquarters), and Flatechs B.V. (Amersfoort, Netherlands, European headquarters). Revenue is generated through hardware sales of single-use syringes sold in 50-unit cases via a hybrid go-to-market model combining direct field sales with distributor networks. The company targets academic medical centers, healthcare systems, government/military hospitals, and pain specialists, and has secured group purchasing access through Vizient, a 10-year DAPA agreement with the U.S. Defense Logistics Agency (distributed by Owens and Minor), and MDR certification enabling European market access.

Commercially, the company is in an active growth phase, having closed Series B and Series C funding rounds in 2023 (amounts undisclosed), with the Series C led by Taiwania Capital. Regulatory milestones include FDA 510(k) clearance (2019), CE Mark (2018), MDR certification (2022), and a Vizient Innovative Technology contract. The company has named reference customers at Brigham and Women's Hospital, Stanford University Hospital, UW Medicine, and Mayo Clinic, and is pursuing regulatory approvals across five APAC markets (Australia, Japan, South Korea, India, Vietnam). Recent leadership additions, including a former B. Braun executive as Strategic Advisor, signal preparation for broader commercial scale.

Name

Flat Medical

Legal name

Flat Medical Co. Ltd.

Website

https://flatmedical.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Flat Medical is a Taiwan-based medtech company developing pressure-sensing smart syringes (EpiFaith, EpiFaith CV) and bioimpedance tissue-recognition needles (IQ-Tip) to improve safety in anesthesia, pain management, and critical care procedures. The company sells through direct sales and distributor networks to academic medical centers, health systems, and U.S. military hospitals across North America, Europe, and APAC.

Ownership category

akta.pro rank

Product category

Interventional Anesthesia Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Prefilled Syringes & Safety Syringes (HLAHAIAA)

akta.pro secondary industry

Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL)

Keywords

• Pressure-sensing syringes
• Epidural placement devices
• Central venous catheterization
• Bioimpedance needle systems
• Clinical safety medical devices

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of EpiFaith Smart Syringe and EpiFaith CV devices to healthcare providers, hospitals, and clinical facilities. Products sold as standalone syringes with compatible connectors (Luer Slip, Luer Lock, NRFit).

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Flat Medical develops and manufactures pressure-sensing smart syringes and bioimpedance-based needle systems for safer clinical needle-based procedures. Its flagship EpiFaith Smart Syringe provides visual confirmation of epidural space entry, while the EpiFaith CV detects arterial entry during central venous catheterization. The company also offers the IQ-Tip smart needle system using bioimpedance tissue recognition technology, serving anesthesiologists, pain physicians, critical care, and emergency medicine specialists.

Product overview

Flat Medical offers a portfolio of precision safety medical devices focused on improving procedural safety in anesthesia, pain management, critical care, and emergency medicine. The core product line includes the EpiFaith Smart Syringe for epidural placement and EpiFaith CV for central venous catheterization, both featuring pressure-sensing technology with visual indicators to help clinicians avoid dangerous complications. The company has recently expanded its portfolio through acquisition of the IQ-Tip smart needle system with bioimpedance tissue recognition technology.

Differentiator

Problem solved

Functional benefit

Brands

• EpiFaith: Smart syringe with visual indicator for epidural space localization, designed to provide objective feedback during loss-of-resistance technique to reduce accidental dural punctures.
• EpiFaith CV
• IQ-Tip

Products and services

• EpiFaith Smart Syringe A visualized loss-of-resistance syringe that provides clear visual confirmation (via colored ring and piston movement) when the epidural space is entered, helping anesthesiologists, pain physicians, and trainees accurately place epidurals and reduce accidental dural punctures. Available in Luer Slip, Luer Lock, and NRFit connector variants. Packaged in cases of 50 units and sold quote-based.
• EpiFaith CV An auto-aspirating syringe with pressure-sensing mechanism for safe central venous catheterization. Features real-time arterial puncture warning via a visual pressure indicator above 30 mmHg and an innate safety lock preventing guidewire insertion when high arterial pressure is detected. Targets anesthesiologists, intensivists, and emergency medicine clinicians performing CVC placement.
• IQ-Tip Smart Needle System A smart needle system using bioimpedance-based tissue recognition technology for precise identification of various tissue types during medical procedures. FDA-designated breakthrough device, intended for procedures such as lumbar punctures and other needle-based interventions where accurate tissue identification improves safety.

Quantifiable outcome

• 96% first-stick success rate in multi-center study (44/46 procedures)
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Six partnerships are on record, tiered supporting and core.

• Eric SteensupportingStrategic or Co-development Partner · 5 January 2026Former B. Braun executive with 25+ years medical device industry experience appointed as Strategic Advisor to guide capital strategy and global market expansion.
• Owens and MinorcoreChannel Partner/ Reseller/ Distributor · 1 February 2023Leading healthcare distributor serves as prime vendor for EpiFaith products to U.S. military hospitals under DAPA agreement. Key channel partner for government healthcare market.
• Amedifact Co., Ltd.supportingChannel Partner/ Reseller/ Distributor · 1 February 2023Contract manufacturer of EpiFaith products, producing devices under ISO13485:2016 and Taiwanese GMP certifications.
• British Standards Institution (BSI)supportingTechnology or Integration · 12 July 2022Notified Body that awarded MDR certification to EpiFaith CV, making Flat Medical the first Taiwanese medtech company to receive BSI MDR certification.
• Dr. Gregory Schears (Mayo Clinic)coreStrategic or Co-development Partner · 12 July 2022Professor at Mayo Clinic and world-renowned expert in intensive care and vascular access appointed to scientific advisory board to guide EpiFaith CV development and clinical strategies.
• GEDSA (Global Enteral Device Supplier Association)supportingStrategic or Co-development Partner · 17 February 2022Flat Medical joined Stay Connected initiative advocating for NRFit connector adoption to prevent misconnection incidents in neuraxial anesthesia procedures.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• B. Braun: Global medical device incumbent with deep portfolios in syringes, regional anesthesia, and IV/catheter products; most directly comparable because Flat Medical's former B. Braun executive (Eric Steen) now advises Flat Medical, and B. Braun's Perifix and loss-of-resistance kits overlap directly with EpiFaith.
• Vygon: European specialist in single-use medical devices for anesthesia, neonatology, and IV therapy; comparable because Vygon sells procedural safety devices into the same European hospital channels Flat Medical targets with EpiFaith and EpiFaith CV.

Broad incumbents

• Becton Dickinson (BD): Dominant manufacturer of conventional and safety syringes, needles, and drug-delivery devices; comparable because BD competes in the same procedural consumables category EpiFaith targets and bundles against in hospital contracts.
• ICU Medical (Smiths Medical): Owns Smiths Medical's syringe, IV, and vascular access portfolio (e.g., Portex, Jelco); directly comparable to EpiFaith's epidural and central-line use cases and to ICU Medical's safety syringe strategy.
• Teleflex: Manufacturer of Arrow central venous catheters, epidural kits, and other anesthesia/vascular access products; competes head-to-head with EpiFaith in CVC placement and epidural procedures.
• Nipro: Global manufacturer of syringes, needles, and dialysis/vascular access products with strong APAC presence; comparable because Nipro competes on safety syringes in Asia-Pacific markets where Flat Medical is currently expanding.

Emerging players

• Sarstedt: Mid-sized European manufacturer of injection, blood-collection, and specialty syringe systems; comparable as a privately held specialist competing in safety-engineered procedural devices similar to EpiFaith.

Others

• Cardinal Health: Major U.S. medical product distributor and manufacturer of clinical and surgical products; comparable as a channel-side counterpart that influences hospital adoption of safety syringe and procedural consumables.
• Medline Industries: Largest privately held medical supply manufacturer and distributor; comparable because Medline's hospital sales force and GPO relationships determine which safety syringe and procedural consumables get adopted at scale.
• Owens & Minor: Flat Medical's named prime-vendor distributor into the U.S. military health system under the DAPA agreement; relevant as the channel partner whose reach materially shapes EpiFaith's installed base in federal facilities.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/channel/UCr8kQsYBYMrsE-EOUelA8uQ
• LinkedInlinkedin.com/company/flat-medical-inc.

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries2 records

Funding overview

Funding rounds4 records

Investors6 records

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

M&A1 record

Investments

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

Frequently asked questions about Flat Medical