Medical Device Cybersecurity Solutions Market to Reach US$ 101.5 Billion by 2033 at 26% CAGR, Driven by Rising Cyber Threats and Connected Healthcare

According to DataM Intelligence, the global medical device cybersecurity solutions market was valued at USD 16.7 billion in 2025 and is projected to reach USD 101.5 billion by 2033, with a reported CAGR of 26%. The market outlook is supported by growing demand for medical device monitoring, vulnerability management, intrusion detection, identity and access management, and secure device lifecycle management.

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Medical Device Cybersecurity Solutions Market Recent Developments

United States

• February 2026 - FDA Updates Medical Device Cybersecurity Guidance: The U.S. Food and Drug Administration issued updated final guidance titled Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions. The guidance outlines recommendations for secure device design, cybersecurity risk management, labeling, and documentation submitted during regulatory review. It also addresses requirements under Section 524B of the Federal Food, Drug, and Cosmetic Act for certain cyber devices. The update reinforces demand for cybersecurity testing, vulnerability assessment, software security documentation, and post-market monitoring solutions.

• March 2026 - Stryker Cyberattack Highlights Healthcare Cybersecurity Risks: On March 11, 2026, medical technology company Stryker reported a cyberattack that disrupted its Microsoft-based corporate environment globally. The incident affected order processing, manufacturing, and shipping activities. Stryker subsequently stated that its connected and other medical products remained unaffected and safe to use. The incident highlighted the importance of network segmentation, business continuity planning, incident response, and cybersecurity monitoring across medical technology operations.

• April 2026 - Medtronic Reports Cybersecurity Incident: Medtronic disclosed that a cybersecurity incident had affected some corporate IT systems in April 2026. In a June 29 update, the company stated that it had not identified impacts on product security, patient safety, manufacturing, or distribution. The incident underscored the importance of separating corporate IT infrastructure from medical device environments and protecting sensitive personal information. It also reinforced the need for security controls across medical device manufacturers' internal systems and supply chains.

Japan

• January 2026 - Greater Focus on Medical Device Lifecycle Security: Healthcare organizations and medical device manufacturers across Asia-Pacific face growing requirements to secure connected medical equipment, healthcare networks, and patient data as digital health infrastructure expands. Legacy devices, third-party software, and inconsistent patching processes create additional security challenges. These conditions support demand for cybersecurity assessment, asset visibility, identity management, and threat detection. This is a regional market trend rather than a single announced transaction or government initiative.

• Ongoing - Expansion of Connected Healthcare Infrastructure: Increasing use of remote patient monitoring, connected diagnostic equipment, digital imaging systems, and networked hospital devices is expanding the healthcare cybersecurity attack surface. Healthcare providers require solutions that identify connected assets, detect suspicious communication, and reduce the risk of cyber incidents affecting clinical operations. These requirements create opportunities for cybersecurity vendors serving hospitals, medical device manufacturers, and digital health providers.

Medical Device Cybersecurity Solutions Market Mergers and Acquisitions

• ServiceNow - Acquisition of Armis (Completed April 20, 2026): ServiceNow completed its acquisition of Armis for approximately USD 7.75 billion in cash. Armis specializes in identifying and protecting connected assets, including medical devices, IoT systems, operational technology, and enterprise infrastructure. The acquisition strengthens ServiceNow's capabilities in cyber risk visibility and security management, creating opportunities to integrate medical device discovery with enterprise workflows, risk prioritization, and remediation.

• Axonius - Acquisition of Cynerio (July 29, 2025): Axonius acquired Cynerio, a healthcare IoT and medical device security specialist, in a cash-and-stock transaction valued at more than USD 100 million. The acquisition expanded Axonius's capabilities in discovering, monitoring, and protecting connected healthcare devices, including equipment that traditional IT security tools may not adequately identify. In April 2026, Cynerio evolved into Axonius Cyber-Physical Assets, extending these capabilities within the Axonius Asset Cloud platform.

• Claroty - Acquisition of Medigate (Completed January 10, 2022): Claroty completed its acquisition of Medigate, a healthcare IoT security company specializing in connected medical device protection. The transaction expanded Claroty's visibility and threat detection capabilities across healthcare environments. Although completed before the current reporting period, the acquisition remains relevant as an example of consolidation in healthcare cybersecurity and the integration of specialized medical device security into broader cyber-physical security platforms.

Medical Device Cybersecurity Solutions Market Segmentation

By Solution
• Data Loss Prevention Solutions
• Antivirus and Antimalware Solutions
• Intrusion Detection Systems and Intrusion Prevention Systems
• Risk and Compliance Management
• Identity and Access Management Solutions

By Device Type
• Wearable and External Medical Devices
• Internally Embedded Medical Devices
• Hospital Medical Devices

By End User
• Hospitals
• Medical Device Manufacturers

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Top 5 Companies in the Medical Device Cybersecurity Solutions Market

• ServiceNow, Inc. (including Armis)
• Claroty Ltd.
• Axonius, Inc. (including Axonius Cyber-Physical Assets)
• MedCrypt, Inc.
• Forescout Technologies, Inc.

Company Profiles

ServiceNow, Inc. / Armis: ServiceNow is a U.S.-based enterprise software company offering workflow automation, IT service management, security, and risk management solutions. Following its April 2026 acquisition of Armis, ServiceNow expanded its cybersecurity capabilities to include real-time visibility and protection for connected assets, including medical devices. The combined capabilities support asset discovery, cyber exposure management, and coordinated risk remediation across healthcare and other complex environments.

Claroty Ltd.: Claroty is a cybersecurity company specializing in cyber-physical systems across healthcare, industrial, and enterprise environments. Its healthcare security capabilities help organizations identify connected medical devices, assess vulnerabilities, and monitor network activity. The company's acquisition of Medigate strengthened its healthcare IoT security portfolio, supporting the protection of medical equipment and clinical technology infrastructure.

Regional Analysis of the Medical Device Cybersecurity Solutions Market

United States

The FDA's February 2026 cybersecurity guidance reinforces the importance of security-by-design, premarket cybersecurity documentation, and lifecycle risk management for applicable medical devices. Meanwhile, healthcare cybersecurity incidents continue to demonstrate the operational consequences of attacks on medical technology companies. These factors support demand for specialized cybersecurity platforms and services across the U.S. healthcare ecosystem.

Conclusion

The medical device cybersecurity solutions market growth is benefiting from the expansion of connected healthcare technologies, rising cyber threats, and increasing regulatory emphasis on medical device security. Hospitals and medical device manufacturers require effective solutions to identify connected assets, manage vulnerabilities, protect sensitive information, and maintain clinical continuity.

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