
GE HealthCare Recall: Why a Cybersecurity Flaw Now Carries Regulatory Weight
A recent FDA Class II recall involving GE HealthCare’s Centricity Universal Viewer is another sign that medical device cybersecurity is no longer being treated as
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A recent FDA Class II recall involving GE HealthCare’s Centricity Universal Viewer is another sign that medical device cybersecurity is no longer being treated as

The European Commission has opened a public consultation on draft guidance for the Cyber Resilience Act (CRA). The consultation allows companies, developers, and industry stakeholders

March 2026 Where We’ve Been: A Decade of Reactive Cybersecurity To understand why the newly released Cyber Strategy for America matters, it helps to understand

Many modern medical devices contain hundreds of software components sourced from multiple suppliers across the global software supply chain. When a vulnerability disclosure appears, hospitals

The cybersecurity market is getting hit hard on the stock market. Palo Alto Networks, CrowdStrike, Cloudflare, Zscaler, the companies that defined enterprise security for the

The Cyber Resilience Act establishes cybersecurity requirements as a condition for placing products with digital elements on the European market, with phased obligations beginning in

Why February 2, 2026 was not just another regulatory date February 2, 2026 marked a watershed moment for the medical device industry. On that date,

CVE-2025-36911, widely known as “WhisperPair,” recently exposed a critical class of vulnerabilities in Bluetooth audio accessories that rely on Google’s Fast Pair protocol. But here

The recent FDA Class I recall and safety alert involving Abiomed, Inc.’s Automated Impella Controller (AIC), due to cybersecurity vulnerabilities, is a powerful reminder that
CRO
C2A Security
VP and GM, Medical Technology
C2A Security
Ken Zalevsky brings over 20 years of medical device cybersecurity experience to his role at C2A Security, where he serves as VP and GM, Medical Technology, following the acquisition of Vigilant Ops in October 2025. A former Bayer executive, Ken founded Vigilant Ops in 2019 after witnessing the consequences of inadequate technical preparation in the healthcare industry. He is an active contributor to CISA’s SBOM working groups and a frequent speaker on software supply chain security. Ken’s mission: transform SBOM from a compliance checkbox into operational intelligence that keeps patients safe while streamlining regulatory processes.