AI in Neonatal Care Market is expected to reach US$ 8.23 billion by 2033 | Major players - IBM, Sibel Health, Inc., CuboAi, Invidyo.

Market Size and Growth:

The Global AI in Neonatal Care Market Size reached US$ 1.14 billion in 2024 and is expected to reach US$ 8.23 billion by 2033, growing with a CAGR of 21.6% during the forecast period 2025-2033.

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The AI in Neonatal Care Market refers to the adoption of artificial intelligence technologies to enhance newborn healthcare through early diagnosis, real-time monitoring, predictive analytics, and automated clinical decision support. It focuses on improving outcomes in premature and at-risk infants by integrating AI-driven tools in NICUs, enabling faster interventions, reduced complications, and improved workflow efficiency for healthcare providers.

United States: Recent Developments of AI in Neonatal Care Market

✅ December 2025: AI and analytics integration in neonatal care devices have advanced predictive monitoring and data-driven decision-making, enhancing neonatal outcomes by supporting early detection and intervention in NICUs.

✅ November 2025: A U.S. company received FDA clearance for a clinical-grade continuous monitoring platform for neonates and infants, which uses AI to monitor vital signs continuously regardless of gestational age, improving care personalization.

✅ October 2025: AI-powered diagnostic tools in NICUs are being further developed to use predictive analytics for earlier intervention and optimize individualized neonatal care, despite challenges in data quality and model validation.

Europe: Recent Developments of AI in Neonatal Care Market

✅ December 2025: The European Commission is establishing AI-powered advanced screening centers to support testing and validation of AI models in healthcare, including neonatal care, along with a network to share best practices, accelerating AI adoption and safety.

✅ November 2025: Europe is seeing growth in AI-enabled neonatal intensive care equipment, boosted by government healthcare programs and rising demand for high-quality neonatal services enhanced by telemedicine and AI-powered monitoring.

✅ October 2025: European hospitals are increasingly adopting AI-driven decision support tools for NICUs that improve ventilation management, remote monitoring, and clinical decision-making, contributing to better neonatal outcomes and cost efficiencies.

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Recent FDA & Regulatory Approvals and Clearances in 2025:

✅ Ceribell announced on November 24, 2025 that Clarity® algorithm received 510(k) clearance from U.S. Food and Drug Administration (FDA) for use in pre‐term neonates through adults. This makes it the first and only AI‐powered point‐of‐care EEG cleared for electrographic seizure detection across all age groups, including preterm newborns. The clearance was supported by an EEG dataset from more than 700 patients. c

✅ CergenX - a spin‐out from a European maternal & child‐health research centre - received Breakthrough Device Designation from FDA in early 2025 for its AI-based neonatal brain monitoring system, the Wave device. The company was also accepted into FDA's Total Product Lifecycle Advisory Program (TAP), signalling priority review and close regulatory cooperation.

✅ In September 2025, Sentec obtained FDA clearance for its LuMon EIT system - described as the first electrical impedance tomography (EIT) system indicated for premature infants and spontaneously‐breathing patients in the U.S. This represents a regulatory milestone for neonatal patient monitoring beyond classical EEG or ventilation devices.

Major Players:

Key companies in the AI in Neonatal Care market include:

IBM
Sibel Health, Inc.
CuboAi
Invidyo
CergenX
Snorble
LittleOne.Care
Bloom Standard
Wadhwani AI
Maxi-Cosi

Segments Covered in the AI in Neonatal Care Market:

By Product: Thermoregulation Devices, Monitoring Systems, Phototherapy Equipment, Ventilation Systems, Screening Devices, Others.

By Application: Neonatal Hypothermia & Low Birth Weight, Jaundice, Gastrointestinal Diseases, Respiratory Diseases, Retinopathy, Sepsis, Others.

By Distribution Channels: Hospitals, Pediatric and Neonatal Clinics, Nursing Homes, Others.

Regional Analysis for AI in Neonatal Care Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, AI in Neonatal Care market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global AI in Neonatal Care Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global AI in Neonatal Care market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the AI in Neonatal Care Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of AI in Neonatal Care market?

➠ Who are the global key manufacturers of the AI in Neonatal Care Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the AI in Neonatal Care market opportunities and threats faced by the vendors in the global AI in Neonatal Care Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the AI in Neonatal Care market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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