HTMwire
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MedCrypt

Device Security Platforms

HTMwire assessment

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

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Key Features

  • ✓ Helm: SBOM and vulnerability management with prioritization
  • ✓ Guardian: Embedded cryptographic protection for device data and code signing
  • ✓ Canary: Field monitoring for device behavior anomalies
  • ✓ Cybersecurity-enabled Quality Fabric (CeQ) for Secure Product Development Framework
  • ✓ Self-service security intelligence platform with financial risk quantification

What It Helps You Do

Embedded cryptography and PKI SBOM and vulnerability management FDA-aligned device security Field monitoring

What Sets Them Apart

Only company focused on embedding security into medical devices at the manufacturer level — team members helped write the FDA cybersecurity guidance they help companies comply with.

How MedCrypt Uses AI

No AI/ML

HTMwire's independent read on the technology — not the vendor's marketing claim.

Key Numbers

  • ▪ $25M Series B (Nov 2022); more than $36M raised to date
  • ▪ Works with 7 of the top 10 medical device manufacturers

Integrations

NetRise C2A Security Thirdwayv

Tags

embedded-security medical-device-manufacturer fda-compliance sbom

Trust Signals

Founders
Founded in 2016 by CEO Mike Kijewski, who previously founded radiation-oncology software startup Gamma Basics (acquired by Varian Medical Systems in 2013); holds an MBA from Wharton and a Master of Medical Physics from the University of Pennsylvania.
Certifications
Team helped create FDA cybersecurity guidance frameworks and IEEE standards
Investors / Funding
$25M Series B (2022) led by Intuitive Ventures and Johnson & Johnson Innovation (JJDC), with Section 32, Eniac Ventures, Anzu Partners, and Dolby Family Ventures; Series B extension from Dexcom Ventures; more than $36M raised to date.

Frequently Asked Questions

What does MedCrypt actually sell and to whom?

MedCrypt sells embedded cybersecurity to medical device manufacturers, not hospitals directly. Its products are Guardian (cryptography and PKI for secure communication and signed updates), Helm (SBOM and vulnerability management built for medical device makers), and Canary (security monitoring of device behavior in the field).

Does MedCrypt help with FDA premarket cybersecurity requirements?

Yes. MedCrypt's tooling is built to help manufacturers meet FDA premarket cybersecurity expectations such as SBOM generation, vulnerability management, and cryptographic protection, and its leadership is active in industry dialogue on FDA guidance.

How is MedCrypt funded and who leads it?

MedCrypt raised a $25M Series B in November 2022 led by Intuitive Ventures and Johnson & Johnson Innovation (JJDC), with Section 32 participating, bringing funding to date to more than $36M after a Dexcom Ventures extension. CEO Mike Kijewski previously founded Gamma Basics, acquired by Varian Medical Systems in 2013.

Which device manufacturers use MedCrypt?

MedCrypt states it provides security features for seven of the top 10 medical device manufacturers and added 18 new OEM partners in 2022, but it does not publicly name those manufacturers. Named technology partners include NetRise, C2A Security, and Thirdwayv.

Sources

  1. PR Newswire: MedCrypt raises $25M Series B (Intuitive Ventures, JJDC, Section 32)
  2. MedCrypt About: Kijewski / Gamma Basics / Varian; $36.4M to date
  3. 24x7: MedCrypt extends Series B with Dexcom; product detail

We cite a primary or named source for every claim on this page. How we evaluate →

Last updated: June 9, 2026