Medical Device Cybersecurity

Aerstone is a cybersecurity consultancy offering compliance assessments, penetration testing, vulnerability management, security architecture, roadmapping, and training, with a dedicated MedTech line advertised as end-to-end FDA cybersecurity compliance for medical devices. It is a Service-Disabled Veteran-Owned Small Business with NSA-certified vulnerability assessor and PCI QSA credentials. For HTM teams this is mostly a manufacturer-facing offering: the FDA premarket cybersecurity work serves device makers, though Aerstone's broader assessment and penetration testing services can apply to healthcare organizations.

Agentless asset intelligence platform discovering and securing IT, IoT, IoMT, and OT devices through behavioral baselining and analysis.

Healthcare device security using AI/ML and MITRE ATT&CK analysis to identify, prioritize, and mitigate vulnerabilities across IoMT and OT devices.

Blue Goat Cyber is a MedTech-focused cybersecurity firm that helps medical device manufacturers meet FDA premarket and postmarket cybersecurity requirements. Services include penetration testing, threat modeling, SBOM generation, and submission documentation across 510(k), De Novo, PMA, and IDE pathways. The firm reports supporting 250+ FDA clearances and is an AAMI member.

C2A Security offers a risk-driven DevSecOps platform that automates cybersecurity across the device product lifecycle, from design through deployment, with a focus on regulatory compliance and vulnerability management. Medical device customers include Elekta and Ascensia, and C2A is a Siemens partner.

Healthcare IoT security platform with device discovery, vulnerability management, and threat detection for 900+ device types. Best in KLAS winner.

Clearwater is a healthcare-exclusive cybersecurity, risk management, and HIPAA compliance firm that combines risk-analysis software, advisory services, and 24x7 managed detection and response under one roof. Medical device risk management is one part of a broader enterprise program aimed at hospitals and health systems, so HTM teams typically engage Clearwater as part of a health-system-wide security effort rather than as a standalone device-discovery platform like Medigate or Cylera.

ColorTokens is an enterprise microsegmentation company whose Xshield platform applies Zero Trust segmentation across data centers, cloud, OT, IoMT devices, and clinical applications to stop the lateral spread of ransomware and malware. Its Xshield Gatekeeper applies policies to medical devices without requiring agents on the devices themselves, which suits unmanageable or legacy IoMT equipment. ColorTokens markets a dedicated healthcare practice and was rated a Leader in the Forrester Wave for microsegmentation. This is a direct fit for hospital security and HTM teams concerned with device network exposure.

Cybeats Technologies provides SBOM (Software Bill of Materials) management and device vulnerability management for connected and embedded products. Its platform helps organizations generate, analyze, and continuously monitor software supply chain risk and compliance at scale. Cybeats is publicly traded on the Canadian Securities Exchange (CSE: CYBT).

Product security and compliance platform for device manufacturers, covering firmware vulnerability management and FDA / EU MDR / UNECE regulatory requirements.

CyberMed.ai is a cybersecurity consulting firm that helps medical device companies build secure products and prepare FDA-ready documentation for regulatory submission and clearance.

Healthcare IoT security platform (MedCommand) with digital twin technology for agentless device profiling, threat detection, and risk management.

IoMT security platform with auto-generated microsegmentation policies, device utilization analytics, and compliance reporting for healthcare.

Cyolo provides secure remote privileged access for operational technology and cyber-physical systems, including medical devices. Its platform enables safe, controlled connections between employees, vendors, and critical assets — supporting use cases such as biomed OEM service-access to clinical equipment.

Device Authority makes KeyScaler, an Identity and Access Management (IAM) and PKI platform that automates the full lifecycle of device identities and credentials for large IoT and connected-device deployments, including unmanaged edge devices. It provides automated provisioning, authentication, credential management, and policy-based end-to-end data encryption, and markets a healthcare and connected medical device vertical. For hospital HTM and security teams the relevance is real but the platform is buyer-agnostic across industries: it is strongest where an organization owns and operates many connected devices at scale, and is also adopted by device manufacturers.

Exein provides embedded and firmware security for IoT and connected devices, protecting devices at the firmware and runtime level. The company reports protecting 80M+ devices and offers tooling aligned with the EU Cyber Resilience Act.

Product security platform specializing in firmware analysis and software bill of materials (SBOM) generation for connected medical devices.

NAC-based healthcare security combining Forescout device visibility with CyberMDX IoMT specialization, covering IT, IoT, OT, and medical devices.

Fortified Health Security is a healthcare-only managed security services provider (MSSP) offering Managed XDR, managed SIEM and endpoint detection, incident response, and managed connected medical device security. Its Central Command platform includes an EscalationIQ module that prioritizes alerts by threat severity and clinical context to cut noise. HTM teams engage Fortified mainly through its connected medical device security service inside a broader health-system security program.

FOSSA automates software supply chain security, including SBOM management, security scanning, and open-source license compliance across third-party dependencies. For medical device makers, FOSSA supports FDA SBOM compliance requirements throughout the software development lifecycle.

Healthcare digital identity platform — SSO, MFA, proximity badge authentication, privileged access, and medical device access controls for HIPAA.

Innolitics is an engineering and regulatory consulting firm specializing in AI-enabled medical device software (SaMD). It supports FDA compliance, including cybersecurity for 510(k) and PMA submissions, and is recognized for AI/ML SaMD work delivered for client devices.

Manifest Cyber is a software supply chain security platform that automates the generation, management, and continuous monitoring of Software Bills of Materials (SBOMs) to surface vulnerabilities, licensing risks, and compliance gaps. The company explicitly serves medical devices and healthcare among its target industries, with workflows for exploitability-aware vulnerability management and AI/software supply chain governance. For hospital HTM teams this is a partial fit: the primary buyer is the medical device manufacturer producing the SBOMs, though healthcare providers also use it to inventory and assess third-party software risk.

Embedded cybersecurity for medical device manufacturers — SBOM management, cryptographic protection, and vulnerability monitoring for FDA compliance.

MediTechSafe provides a patented, risk-based device security and vulnerability management platform for medical devices and enterprise security across healthcare and other critical industries. The company is a member of MTEC (Medical Technology Enterprise Consortium).

Medical device cybersecurity firm offering the BRIDGE platform and advisory services to help hospitals build a roadmap to device-security resilience.

MedSecure USA is a consultancy specializing in FDA Section 524B premarket cybersecurity documentation for medical device manufacturers. It produces a fixed-price package of the 12 documents a cyber device submission requires, including the Security Risk Management Plan, threat model and security architecture, machine-readable SBOM and vulnerability assessment, penetration test report, labeling, and vulnerability disclosure policies, with a stated 6 to 8 week delivery. The buyer is the device manufacturer preparing an FDA submission, so for hospital HTM teams this is manufacturer-facing context rather than a direct purchase.

Microsoft Defender for IoT is an agentless network monitoring solution for IoT, IoMT, and OT environments, providing asset discovery, vulnerability management, and threat detection. Built on Microsoft's 2020 acquisition of CyberX, it offers native integration with Microsoft Sentinel and the M365 security stack for unified SOC operations across connected medical and industrial devices.

Mondoo is an agentic vulnerability management service that autonomously assesses attack surface and prioritizes and remediates vulnerabilities across IT and connected device environments, including IoMT. Rather than only reporting findings, Mondoo delivers code fixes and pull requests and pairs AI agents with security experts. The company reports 300+ customers and integration with 70+ security tools.

OT and IoT/IoMT security platform providing network monitoring and behavioral anomaly detection across healthcare and building-automation environments.

AI-powered medical device discovery and security with behavioral modeling, automated microsegmentation, and Zero Trust policy for healthcare.

Medical IoT Security with ML-powered device discovery, MDS2 risk assessment, behavioral anomaly detection, and Zero Trust clinical device segmentation.

Phosphorus Cybersecurity offers an xIoT cyber-physical security platform that discovers, assesses, hardens, and continuously monitors connected devices at enterprise scale, including IoMT in healthcare. Unlike monitoring-only tools, Phosphorus emphasizes proactive remediation and device hardening. The company has raised $65M and is now part of Dragos.

Sensato Cybersecurity is a medical device security program built around MD-COP (Medical Device Cybersecurity Operations Program), which combines compliance assessment, asset fingerprinting, intrusion detection, network monitoring, and a 24x7 security operations center (SOC) with incident response. Sensato was acquired by CloudWave in 2022 and now operates within CloudWave's healthcare cybersecurity portfolio, so it is best evaluated alongside that parent.

Sepio provides hardware-based asset visibility through AssetDNA, a layer-1 physical-layer fingerprinting technology that identifies and validates every connected device. The approach detects rogue, spoofed, and hidden hardware threats across networks, supporting zero trust hardware security.

Embedded device security platform providing firmware-level runtime protection and observability for connected medical and IoT devices.

Stratigos Security is a medical device product security consultancy that provides FDA-aligned cybersecurity testing for device manufacturers, including threat modeling, penetration testing, code and binary analysis, and documentation formatted for premarket submissions. The firm positions itself as engineering-first and regulatory-aligned, stating its staff advised on and drafted FDA premarket and postmarket cybersecurity guidance. This is a manufacturer-facing offering: the buyer is the device maker preparing an FDA submission, so the value for hospital HTM teams is contextual rather than a direct purchase.

OT and device security platform focused on protecting legacy and connected equipment, including healthcare environments.

Velentium (Velentium Medical) is an engineering-first partner providing integrated medical device development, manufacturing, and cybersecurity services for Class II and Class III devices. Its cybersecurity practice spans risk identification through implementation, positioned alongside product development and test systems from concept to commercialization.

Veridify Security offers DOME, a SaaS platform delivering zero trust security for hospital OT and building management systems (BMS). The platform applies quantum-resistant cryptography to protect operational technology and IoT devices. Veridify is a Synopsys partner.

TRIMEDX-native medical device cybersecurity platform that builds vulnerability management directly into clinical engineering workflows.

Virta Labs makes OpenSecOps, an API-first, MIT-licensed open-core security platform for healthcare infrastructure. It combines BlueFlow asset management, Tapirx passive medical device discovery, and VulnFWRD AI risk orchestration, with FDA SBOM generation and NIST CSF alignment. Hospitals can self-host it. The company is ARPA-H and NSF SBIR funded and was founded by University of Michigan medical-device-security researchers, aiming at HTM, clinical engineering, and IT teams that want inspectable, deployable device security.