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Healthcare & Life SciencesUnited StatesUpdated 4 Nov 2026

Active implantable medical device Market 2026: trade data and key figures

The FDA has 7 510(k) clearances on record for active implantable medical device devices. In the US, the core industry (Electromedical and electrotherapeutic apparatus manufacturing) had 2,220 establishments in 2025. The EU counted 1,791 enterprises in the related industry class.

Edited by the Stratum Market Research editorial team. Updated 4 Nov 2026.

Headline figure

7510(k) clearances

FDA 510(k) clearances on record

PubMed papers per year mentioning implantable medical device20202025 U.S. Food and Drug Administration, 4 Nov 2026

1,791 enterprises

The EU had 1,791 enterprises in NACE class C2660 (Manufacture of irradiation, electromedical and electrotherapeutic equipment) in 2023.

Eurostat

30.54 EUR billion

EU enterprises in NACE class C2660 had net turnover of €30.54 billion in 2023.

Eurostat

74,126 persons employed

NACE class C2660 employed 74,126 people across the EU in 2021.

Eurostat
ChartPubMed papers per year mentioning implantable medical device
PubMed papers per year mentioning implantable medical device06.2512.518.8252020: 18 papers1820202021: 23 papers20212022: 23 papers20222023: 18 papers20232024: 15 papers20242025: 17 papers172025

Source: U.S. National Library of Medicine (PubMed)

Why this market is moving now

  • US employment in the core industry shifted -1% since 2020.

What this market covers

Devices placed in the body that use a power source to treat conditions, such as pacemakers, neurostimulators and cochlear implants. Hospitals and specialist clinics implant them.

Typical segments

  • Cardiac rhythm devices
  • Neurostimulators
  • Cochlear implants
  • Implantable drug pumps

Who buys

  • Hospitals
  • Cardiology centres
  • Neurosurgery centres

Key figures

Each figure links to the page it came from.

FigureValueYearSource
The EU had 1,791 enterprises in NACE class C2660 (Manufacture of irradiation, electromedical and electrotherapeutic equipment) in 2023.1,791 enterprises2023Eurostat
EU enterprises in NACE class C2660 had net turnover of €30.54 billion in 2023.30.54 EUR billion2023Eurostat
NACE class C2660 employed 74,126 people across the EU in 2021.74,126 persons employed2021Eurostat
The US had 2,220 private establishments in NAICS 334510 (Electromedical and electrotherapeutic apparatus manufacturing) in 2025.2,220 establishments2025U.S. Bureau of Labor Statistics
NAICS 334510 employed an average of 72,575 people in US private industry in 2025.72,575 jobs2025U.S. Bureau of Labor Statistics
US employment in NAICS 334510 changed by -1% between 2020 (73,147 jobs) and 2025, calculated from BLS figures.-1 % change2025U.S. Bureau of Labor Statistics
Average annual pay in US NAICS 334510 was $140,429 in 2025.140,429 USD per year2025U.S. Bureau of Labor Statistics
The FDA has recorded 7 510(k) clearances for devices named "implantable pulse generator".7 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Intermedics, Inc. holds 5 510(k) clearances for devices named "implantable pulse generator".5 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Boston Scientific Neuromodulation holds 2 510(k) clearances for devices named "implantable pulse generator".2 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
PubMed indexed 17 papers mentioning "implantable medical device" in the title or abstract in 2025.17 papers2025U.S. National Library of Medicine (PubMed)

Companies to watch

Intermedics, Inc.

5 FDA 510(k) clearances for devices named "implantable pulse generator".

Boston Scientific Neuromodulation

2 FDA 510(k) clearances for devices named "implantable pulse generator".

What the full report covers

Illustration of a report page with its five main parts numbered12345
  1. 1

    Executive summary

    The answer on two pages: size, growth and what drives it.

  2. 2

    Market size and outlook

    History, the current year and a five-year view with base, low and high cases.

  3. 3

    Segments and regions

    Splits by product, buyer and geography across the US, Europe and MEA.

  4. 4

    Company profiles

    The main players, how they compete and where they are investing.

  5. 5

    Data and method

    Every figure in Excel, with the sources and assumptions behind it.

  1. 01Executive summary
    The answer in one page: size, direction and what moves it
  2. 02Market definition and scope
    What is in and out of the United States market
  3. 03Market size, 2021 to 2025
    Historical series and growth rates
  4. 04Outlook to 2031
    Base, low and high scenarios with stated assumptions
  5. 05Rules, policy and deadlines
    Regulation and programmes that change demand
  6. 06Drivers and barriers
    What accelerates or slows adoption, by customer segment
  7. 07Prices, costs and margins
    Unit economics where public data allows
  8. 08Competitive landscape
    8 to 12 company profiles with recent moves
  9. 09Opportunities and risks
    For new entrants, suppliers and investors
  10. 10Method and sources
    Every assumption and source, listed

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Frequently asked questions

How many active implantable medical device devices are cleared by the FDA?

openFDA lists 7 510(k) clearances for devices named implantable pulse generator.

Which companies hold the most FDA clearances for active implantable medical device?

By 510(k) count: Intermedics, Inc., Boston Scientific Neuromodulation.

How many US companies are in the active implantable medical device industry?

BLS counts 2,220 private establishments in NAICS 334510 (Electromedical and electrotherapeutic apparatus manufacturing), the closest official industry.

How many EU companies are in the active implantable medical device industry?

Eurostat counts 1,791 enterprises in NACE class C2660 (Manufacture of irradiation, electromedical and electrotherapeutic equipment).

Sources and method

The figures on this page come from the public sources listed below. Read how we work.

  1. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs ENT_NR, 2023, 1791
  2. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs NETTUR_MEUR, 2023, 30540
  3. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs EMP_NR, 2021, 74126
  4. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_estabs 2220
  5. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_emplvl 72575
  6. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)QCEW 2020 annual_avg_emplvl 73147; 2025 annual_avg_emplvl 72575
  7. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 334510, avg_annual_pay 140429
  8. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "implantable pulse generator" (2026-11-04)openFDA device/510k device_name:"implantable pulse generator", sum of counts by decision_date = 7
  9. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "implantable pulse generator" (2026-11-04)applicant.exact "Intermedics, Inc." count 5
  10. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "implantable pulse generator" (2026-11-04)applicant.exact "Boston Scientific Neuromodulation" count 2
  11. U.S. National Library of Medicine (PubMed): PubMed search "implantable medical device"[tiab] AND 2025[dp] (2026-11-04)esearch count 17

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