PALO ALTO, Calif.–(BUSINESS WIRE)–#AIinHealthcare–Quantum Knight, a pioneer in quantum-secure encryption and cybersecurity innovation, has reached a major milestone with its flagship cryptosystem CLEAR™ (Cryptographic Layer for Enterprise Access and Resilience) becoming the first standalone encryption solution to receive Authority to Operate (ATO) from the U.S. Food and Drug Administration (FDA) for use in life-critical medical and digital infrastructure.
This groundbreaking authorization affirms CLEAR’s compliance with the FDA’s stringent cybersecurity standards for healthcare, biotech, and embedded medical software, opening the door for regulated industries to adopt next-generation post-quantum cryptographic protection. CLEAR 2.X features Kyber and Dilithium, the NIST-selected post-quantum cryptographic standards (FIPS 202, 203, 204), satisfying organizations seeking “quantum-readiness” and future-proof compliance. These PQC algorithms offer proven defenses against quantum computing-based attacks and allow customers to confidently check the “quantum box.”
Quantum Knight goes further. While many stop at PQC, CLEAR combines these algorithms with intelligence-grade symmetric cryptography that is already FDA-approved and battle-tested, delivering unmatched performance and strength across today’s most sensitive environments.
At the heart of this architecture is Hyperkey™, Quantum Knight’s patented innovation that integrates encryption and access control into one seamless, tamper-resistant system. It replaces traditional key management with solid-state authentication and decentralized policy enforcement embedded directly in the key structure itself.
“CLEAR doesn’t just lock the door, it defines who holds the keys and embeds that control directly into the encryption itself,” said Andy Schwaderer, CEO of Quantum Knight. “With this FDA authorization, we’re empowering healthcare and life sciences organizations to protect the core of what matters most: patient data, IP, and the digital lifeblood of the modern medical system.”
Healthcare applications for CLEAR and Hyperkey™ include:
- Tamper-proof medical records, accessible only by cryptographically approved personnel.
- Decentralized data control, removing dependence on vulnerable third-party systems.
- Real-time enforcement of dynamic access policies, including geo-fencing and role-based changes.
Along with future proofing, CLEAR addresses today’s threats head on. CLEAR instantly eliminates man-in-the-middle attacks, harvest-now-decrypt-later strategies, and other active attack surfaces. It guarantees data authenticity and provenance between any two digital points, critical for AI/ML training, cloud synchronization, and compliance. As regulatory landscapes evolve, Quantum Knight’s crypto-agile architecture ensures organizations stay ahead. It enables seamless adaptation and full compliance with upcoming security regulation requirements.
CLEAR is NIST FIPS 140-3 and 140-2 validated, embeds post-quantum cryptographic algorithms Kyber and Dilithium (FIPS 202, 203, 204), and supports compliance with frameworks like NIS2, ensuring organizations remain protected against both current and future threats.
Quantum Knight’s CLEAR is now ready for deployment across patient care platforms, surgical robotics, AI-driven diagnostics, and secure cloud/edge systems, setting a new benchmark for Zero Trust encryption and digital sovereignty.
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