The EU counted 63,227 enterprises in the related industry class.
What this market covers
Cooling caps and machines that chill the scalp during chemotherapy to reduce hair loss. Buyers are cancer centres, hospitals and infusion clinics.
Typical segments
- Cold cap systems
- Machine cooled caps
- Portable cooling units
- Cooling gel caps
Why this market is moving now
- US employment in the core industry rose 4% since 2020.
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 "scalp cooling". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 2 of those clearances were issued from 2021 to 2025. | 2 510(k) clearances | 2025 | U.S. Food and Drug Administration |
| Cooler Heads Care, Inc. holds 1 510(k) clearances for devices named "scalp cooling". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Dignitana Ab holds 1 510(k) clearances for devices named "scalp cooling". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Stemtech Medical Devices Private Limited holds 1 510(k) clearances for devices named "scalp cooling". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
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 "scalp cooling" (2026-11-04)
Quoted lines
- Figure 8
openFDA device/510k device_name:"scalp cooling", sum of counts by decision_date = 3
- Figure 9
openFDA device/510k decision_date 2021-2025 count = 2
- Figure 8
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "scalp cooling" (2026-11-04)
Quoted lines
- Figure 10
applicant.exact "Cooler Heads Care, Inc." count 1
- Figure 11
applicant.exact "Dignitana AB" count 1
- Figure 12
applicant.exact "Stemtech Medical Devices Private Limited" count 1
- Figure 10
Buyers and suppliers
Who buys
- Cancer centres
- Hospitals
- Infusion clinics
Companies to watch
Cooler Heads Care, Inc.
1 FDA 510(k) clearances for devices named "scalp cooling".
Dignitana Ab
1 FDA 510(k) clearances for devices named "scalp cooling".
Stemtech Medical Devices Private Limited
1 FDA 510(k) clearances for devices named "scalp cooling".
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
- PDF report, 40 to 60 pages
- Excel data pack
- Ready-to-use charts
- Method note and assumptions
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Frequently asked questions
How many scalp cooling systems devices are cleared by the FDA?
openFDA lists 3 510(k) clearances for devices named scalp cooling.
Which companies hold the most FDA clearances for scalp cooling systems?
By 510(k) count: Cooler Heads Care, Inc., Dignitana Ab, Stemtech Medical Devices Private Limited.
How many US companies are in the scalp cooling systems 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 scalp cooling systems industry?
Eurostat counts 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies).
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