Rising FDA Approvals Drives the Growth of Pulse Oximeters Market

Published: Nov 2024

Global pulse oximeter market is anticipated to grow at a CAGR of 7.7% during the forecast period (2024-2031). FDA approval expands the market by regulating healthcare device laws, correcting erroneous readings in unregulated pulse oximeters, and ensuring that devices meet international standards for accuracy and reliability. For instance, in February 2024, the FDA cleared a fingertip pulse oximeter for home use, allowing consumers, including those with COPD, to check their blood oxygen levels. Pulse oximeters measure oxygen saturation and heart rate and have been widely available for years. 

  • In May 2024, Masimo obtained FDA clearance for its Stork Over the Counter (OTC) Baby Monitoring System. This is a system that allows parents or caregivers to monitor healthy infants from 0 to 18 months without a prescription. The device tracks an infant's oxygen saturation level, pulse rate, and skin temperature. If the readings go outside of their present range, the device alarms the caregivers.
  • In August 2024, Masimo received FDA 510(k) clearance for its Masimo W1 medical watch, which can be applied to its telemonitoring solution. It uses a single-channel electrocardiogram and pulse oximeter sensor that monitors physiological signals. Its physiological signals are transmitted wirelessly from the wrist to caregivers in a smartphone app.

Browse the full report description of “Pulse Oximeter Market Size, Share & Trends Analysis Report by Product Type (Portable Pulse Oximeters (Fingertip And Wearable), Handheld Oximeter, and Others (Tabletop Pulse Oximeters, Pediatric and Neonatal Oximeters, and Smartphone-Connected Oximeters)), and by End-User (Hospitals, Homecare, and Others (ASCs and Clinics)) Forecast Period (2024-2031)” at https://www.omrglobal.com/industry-reports/pulse-oximeter-market

Market Coverage

The market number available for – 2023-2031

Base year- 2023

Forecast period- 2024-2031

Segment Covered- 

o By Product Type

o By End-User

Regions Covered-

o North America

o Europe

o Asia-Pacific

o Rest of the World

Competitive Landscape - GE HealthCare Technologies Inc., Koninklijke Philips N.V., Medtronic Inc., Nihon Kohden Corp. 

Key questions addressed by the report.

  • What is the market growth rate?
  • Which segment and region dominate the market in the base year?
  • Which segment and region will project the fastest growth in the market?
  • Who is the leader in the market?
  • How are players addressing challenges to sustain growth?
  • Where is the investment opportunity?

Global Pulse Oximeter Market Report Segment

By Product Type

  • Portable Pulse Oximeters (fingertip and wearable)
  • Handheld Oximeter
  • Others (Tabletop Pulse Oximeters, Pediatric and Neonatal Oximeters, and Smartphone-Connected Oximeters)

By End-User

  • Hospitals
  • Homecare
  • Others (ASCs and Clinics)

Global Pulse Oximeter Market Report Segment by Region

North America

United States

Canada 

Europe

UK

Germany

Italy

Spain

France

Rest of Europe 

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific 

Rest of the World

Latin America 

Middle East & Africa


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