In the US, the core industry (Surgical and medical instrument manufacturing) had 4,547 establishments in 2025.
What this market covers
Tests that measure blood pressure across a narrowed heart artery to decide whether it needs a stent. They use pressure wires in the cath lab or software that models flow from CT scans.
Typical segments
- Invasive pressure wire FFR
- CT derived FFR
- Instantaneous wave free ratio
- Analysis software
Why this market is moving now
- US employment in the core industry rose 4% since 2020.
- Clinical research is active, with studies recruiting now.
Key figures
Each figure names the source it came from. Open the source list below to read the quoted line.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023. | 63,227 enterprises | 2023 | Eurostat |
| EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021. | 105.31 EUR billion | 2021 | Eurostat |
| NACE class C3250 employed 600,000 people across the EU in 2023. | 600,000 persons employed | 2023 | Eurostat |
| The US had 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing) in 2025. | 4,547 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 339112 employed an average of 140,413 people in US private industry in 2025. | 140,413 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 339112 changed by +4% between 2020 (135,655 jobs) and 2025, calculated from BLS figures. | +4 % since 2020 | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 339112 was $109,475 in 2025. | 109,475 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 3 510(k) clearances for devices named "pressure guidewire". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Boston Scientific Corporation holds 2 510(k) clearances for devices named "pressure guidewire". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Zurich Medical, Inc. holds 1 510(k) clearances for devices named "pressure guidewire". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| ClinicalTrials.gov lists 12,207 registered studies for the condition "coronary artery disease". | 12,207 registered studies | 2026 | U.S. National Library of Medicine |
| 1,233 of those studies were recruiting participants when checked in November 2026. | 1,233 recruiting studies | 2026 | U.S. National Library of Medicine |
| PubMed indexed 572 papers mentioning "fractional flow reserve" in the title or abstract in 2025. | 572 papers | 2025 | U.S. National Library of Medicine |
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 1
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
- Figure 2
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
- Figure 3
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
- Figure 1
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
Quoted lines
- Figure 4
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
- Figure 5
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
- Figure 6
QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
- Figure 7
QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
- Figure 4
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "pressure guidewire" (2026-11-04)
Quoted lines
- Figure 8
openFDA device/510k device_name:"pressure guidewire", sum of counts by decision_date = 3
- Figure 8
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "pressure guidewire" (2026-11-04)
Quoted lines
- Figure 9
applicant.exact "Boston Scientific Corporation" count 2
- Figure 10
applicant.exact "Zurich Medical, Inc." count 1
- Figure 9
- U.S. National Library of Medicine: ClinicalTrials.gov API v2, condition "coronary artery disease" (2026-11-04)
Quoted lines
- Figure 11
query.cond=coronary artery disease totalCount 12207
- Figure 11
- U.S. National Library of Medicine: ClinicalTrials.gov API v2, condition "coronary artery disease", status recruiting (2026-11-04)
Quoted lines
- Figure 12
filter.overallStatus=RECRUITING totalCount 1233
- Figure 12
- U.S. National Library of Medicine: PubMed search "fractional flow reserve"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 13
esearch count 572
- Figure 13
Buyers and suppliers
Who buys
- Hospitals
- Cardiac catheterization labs
- Cardiology clinics
Companies to watch
Boston Scientific Corporation
2 FDA 510(k) clearances for devices named "pressure guidewire".
Zurich Medical, Inc.
1 FDA 510(k) clearances for devices named "pressure guidewire".
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the United States market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
Included with the full report
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- Method note and assumptions
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Frequently asked questions
How many fractional flow reserve devices are cleared by the FDA?
openFDA lists 3 510(k) clearances for devices named pressure guidewire.
Which companies hold the most FDA clearances for fractional flow reserve?
By 510(k) count: Boston Scientific Corporation, Zurich Medical, Inc..
How many clinical trials study coronary artery disease?
ClinicalTrials.gov lists 12,207 registered studies.
How many US companies are in the fractional flow reserve industry?
BLS counts 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing), the closest official industry.
How many EU companies are in the fractional flow reserve industry?
Eurostat counts 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies).
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