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FDA’s Final Cybersecurity Guidance (June 2025): What Medical Device Manufacturers Must Do Now

Why The New FDA Update Matters Right Now for MDMs

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FDA’s Final Cybersecurity Guidance (June 2025): What Medical Device Manufacturers Must Do Now

August 7, 2025

Why The New FDA Update Matters Right Now for MDMs The FDA’s Final Cybersecurity Guidance of June 2025 introduces significant new requirements under the FD&C Act, making cybersecurity a lifecycle obligation. Section 7 provides the most detailed interpretation to date.  The update consolidates all previous cybersecurity guidance documents and specifies how medical device manufacturers (MDMs) must address both premarket and

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Why SBOMs Are Vital for Medical Device Cybersecurity and Compliance
Every Component Counts: Why SBOMs Are Vital for Medical Device Cybersecurity and Compliance

What is an SBOM and why is it Important? A

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FDA’s Final Cybersecurity Guidance (June 2025): What Medical Device Manufacturers Must Do Now

Why The New FDA Update Matters Right Now for MDMs

Read More
NIS2 Directive
Navigating NIS2: Essential OT Security for EU Manufacturers

Introduction The EU’s Network and Information Systems Directive 2 (NIS2,

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Chinese Itbigtec and C2A Security Formally Establish Strategic Partnership

[Read the Chinese version of this announcement] Tel Aviv, Israel

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ITBigtec Logo
艾体宝与 C2A Security 正式建立合作伙伴关系

[Read the English version of this announcement] 艾体宝正式宣布与全球领先的网络安全合规平台提供商C2A Security达成战略合作。双方将整合国际领先技术与本土化服务能力，为能源、制造、交通、智能终端及关键基础设施等行业提供覆盖产品全生命周期的安全合规解决方案，助力企业高效应对GB 44495-2024、ISO/SAE

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Source: https://arstechnica.com/
Red Teaming AI Systems: Lessons for Secure System Design in Regulated and Connected Environments

AI Red Teaming as a Blueprint for Proactive Product Security

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Contec CMS 8000 Patient Monitoring System
From Backdoors to Bans: What the EU RED Regulation Means for IoT & Medical Device Security

In early 2025, security researchers uncovered a critical vulnerability in

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Medcrypt and C2A Security partnership
C2A Security and Medcrypt Forge Partnership to Elevate Medical Device Security

Medcrypt’s Guardian PKI and Cryptography Platform integrates into C2A Security’s

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patient at a hospital bed with IoT devices around her. AI-generated.
From Bedside to Breach: The Growing Cyber Threat to IoT Healthcare Devices

The interconnected healthcare sector is facing a growing threat from

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