About
MedCrypt provides FDA-focused medical device cybersecurity products and services for manufacturers preparing regulatory submissions. Their platform offers medical device SBOM vulnerability management with AI-driven risk prioritization, automated compliance reporting, and bulk remediation. They also offer regulatory strategy, penetration testing, threat modeling, PKI and certificate management, and process optimization to prepare for 510(k) or PMA submissions and EU/Health Canada filings. Capabilities listed include integrating and analyzing the software supply chain to identify and mitigate vulnerabilities, encrypting data, device management, incident response, automated cryptographic provisioning, and benchmarking product security posture with risk quantification. The company positions its Guardian & Helm platforms to accelerate FDA readiness and claims zero FDA rejections to date.
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Finite State positions itself as a product cybersecurity platform for connected devices and embedded systems. The platform uncovers vulnerabilities in source code, binaries, and third-party components and consolidates risks into a unified view across a product portfolio. Finite State says it can dissect source code or binaries with precision to reduce false positives and help teams prioritize and fix issues, and it offers CI/CD integrations and automatic PRs for remediation workflows. The company highlights compliance-readiness, the ability to generate reports to meet regulatory compliance requirements, and notes it is SOC 2 Type 2 certified. The site also references recorded demos and access to expertise from former U.S. government officials.
Threat Detective is SBOM and vulnerability management software for medical device teams. It imports and validates CycloneDX and SPDX SBOMs, identifies vulnerabilities using NVD, GitHub Security Advisories, and OSV, prioritises findings using CVSS, EPSS, and CISA KEV, and records exploitability, remediation, and mitigation decisions with an auditable history. It turns that vulnerability analysis into submission-ready cybersecurity evidence for medical device regulatory workflows, including FDA premarket submissions, and supports VEX generation. Continuous monitoring then tracks active device and software versions for newly disclosed vulnerabilities throughout post-market surveillance.
