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Telemonitoring system Market 2026: trade data and key figures

The FDA has 75 510(k) clearances on record for telemonitoring system devices. In the US, the core industry (Electromedical and electrotherapeutic apparatus manufacturing) had 2,220 establishments in 2025.

1,791enterprises

The EU had 1,791 enterprises in NACE class C2660 (Manufacture of irradiation

€30.54billion

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

74,126persons employed

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

The EU counted 1,791 enterprises in the related industry class.

What this market covers

Telemonitoring systems collect patient vital signs at home and send them to care teams. Hospitals, home care firms and insurers use them for chronic disease follow up.

Typical segments

  • Vital sign kits
  • Wearable monitors
  • Software platforms
  • Hospital at home kits
ChartFDA 510(k) clearances per year, telemonitoring system
FDA 510(k) clearances per year, telemonitoring system012342016: 2 clearances220162017: 1 clearances2018: 3 clearances20182019: 2 clearances2020: 4 clearances20202021: 2 clearances2022: 2 clearances20222023: 1 clearances2024: 0 clearances2025: 0 clearances02025

Source: U.S. Food and Drug Administration

Why this market is moving now

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

Key figures

Each figure names the source it came from. Open the source list below to read the quoted line.

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 % since 20202025U.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 75 510(k) clearances for devices named "patient monitoring".75 510(k) clearances2026U.S. Food and Drug Administration
5 of those clearances were issued from 2021 to 2025.5 510(k) clearances2025U.S. Food and Drug Administration
Airstrip Technologies, Lp holds 8 510(k) clearances for devices named "patient monitoring".8 510(k) clearances2026U.S. Food and Drug Administration
Covidien holds 7 510(k) clearances for devices named "patient monitoring".7 510(k) clearances2026U.S. Food and Drug Administration
Invivo Research, Inc. holds 6 510(k) clearances for devices named "patient monitoring".6 510(k) clearances2026U.S. Food and Drug Administration
Invivo Corporation holds 5 510(k) clearances for devices named "patient monitoring".5 510(k) clearances2026U.S. Food and Drug Administration
Capsule Technologie Sas holds 3 510(k) clearances for devices named "patient monitoring".3 510(k) clearances2026U.S. Food and Drug Administration
Covidien, Llc holds 3 510(k) clearances for devices named "patient monitoring".3 510(k) clearances2026U.S. Food and Drug Administration
PubMed indexed 357 papers mentioning "telemonitoring" in the title or abstract in 2025.357 papers2025U.S. National Library of Medicine

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)
    Quoted lines
    • Figure 1sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs ENT_NR, 2023, 1791
    • Figure 2sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs NETTUR_MEUR, 2023, 30540
    • Figure 3sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs EMP_NR, 2021, 74126
  2. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)
    Quoted lines
    • Figure 4QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_estabs 2220
    • Figure 5QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_emplvl 72575
    • Figure 6QCEW 2020 annual_avg_emplvl 73147; 2025 annual_avg_emplvl 72575
    • Figure 7QCEW 2025 annual, US000, private, NAICS 334510, avg_annual_pay 140429
  3. U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "patient monitoring" (2026-11-04)
    Quoted lines
    • Figure 8openFDA device/510k device_name:"patient monitoring", sum of counts by decision_date = 75
    • Figure 9openFDA device/510k decision_date 2021-2025 count = 5
  4. U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "patient monitoring" (2026-11-04)
    Quoted lines
    • Figure 10applicant.exact "Airstrip Technologies, LP" count 8
    • Figure 11applicant.exact "Covidien" count 7
    • Figure 12applicant.exact "Invivo Research, Inc." count 6
    • Figure 13applicant.exact "Invivo Corporation" count 5
    • Figure 14applicant.exact "Capsule Technologie Sas" count 3
    • Figure 15applicant.exact "Covidien, LLC" count 3
  5. U.S. National Library of Medicine: PubMed search "telemonitoring"[tiab] AND 2025[dp] (2026-11-04)
    Quoted lines
    • Figure 16esearch count 357

Buyers and suppliers

Who buys

  • Hospitals
  • Home care providers
  • Insurers

Companies to watch

Airstrip Technologies, Lp

8 FDA 510(k) clearances for devices named "patient monitoring".

Covidien

7 FDA 510(k) clearances for devices named "patient monitoring".

Invivo Research, Inc.

6 FDA 510(k) clearances for devices named "patient monitoring".

Invivo Corporation

5 FDA 510(k) clearances for devices named "patient monitoring".

Capsule Technologie Sas

3 FDA 510(k) clearances for devices named "patient monitoring".

Covidien, Llc

3 FDA 510(k) clearances for devices named "patient monitoring".

What the full report covers

  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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  • Method note and assumptions
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Frequently asked questions

How many telemonitoring system devices are cleared by the FDA?

openFDA lists 75 510(k) clearances for devices named patient monitoring.

Which companies hold the most FDA clearances for telemonitoring system?

By 510(k) count: Airstrip Technologies, Lp, Covidien, Invivo Research, Inc., Invivo Corporation.

How many US companies are in the telemonitoring system 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 telemonitoring system industry?

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

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