Ketryx Marks Milestone Year, Impacting Over 20M+ Patients in MedTech

New AI Capabilities, Customer Milestones, and Certifications Power Ketryx Forward

CAMBRIDGE, Mass., Jan. 9, 2025 /PRNewswire/ -- Ketryx, the leader in connected lifecycle management for safety-critical industries, today announced key accomplishments for 2024, marking a pivotal year of growth and innovation.

CEO and founder Erez Kaminski also shared his vision for 2025, including some bold predictions about AI for the coming year.

"2024 has been transformative for Ketryx in expanding customers and their applications to serve well over 20 million patients," said Kaminski. "These milestones are a testament to our team's focus on innovation, our customers' trust, and our belief that MedTech companies can release safe, innovative software at a pace that rivals top technology companies."

Highlights of the Year:

• Building a World-Class Team: In 2024, Ketryx welcomed Zack Jha (PTC, AWS) as SVP of Worldwide Sales, Randall Markham as Chief of Staff (American Industrial Partners, Booz Allen), and Gabriel Pascualy (MITRE, Amgen) as Director of Solutions. These additions strengthened the company's ability to scale operations and serve its growing customer base.
• Customer Milestones: Ketryx signed leading global MedTech manufacturers, including innovators in AI medicine like RadNet, HeartFlow, and Nutrino, as well as numerous Fortune 500 organizations. The company also expanded adoption of its platform with AI/ML-enabled devices across sectors such as surgical robots, radiology and diagnostic imaging.
• Certifications Achieved: Ketryx renewed UL Certification to IEC 62304, ISO 13485, and ISO 14971 and ISO 27001, also achieving SOC 1 and SOC 3 compliance. These certifications demonstrate the company's dedication to maintaining the same high quality and compliance standards as customers while upholding best practices internally.
• Launch of New AI Capabilities, Cybersecurity Features: Ketryx Intelligence saves teams hundreds of hours through the AI-powered creation of requirements, suggested traceability links, and auto-generated release notes. On the cybersecurity front, automated generation of an FDA-ready Software Bill of Materials (SBOM) ensures companies can easily identify, track, and mitigate any vulnerabilities from third-party or open-source software.
• New Integrations: Ketryx expanded its integrations to popular tools including Jama, TestRail, Polarion, and ADO, complementing existing integrations to Jira, GitHub, AWS, and many others.
• Thought Leadership/Education: Erez Kaminski, the CEO and founder of Ketryx and former head of AI/ML at Amgen, has emerged as a leading voice in MedTech. This year, he delivered keynote speeches and presentations at premier conferences including AdvaMed Toronto, RAPS, and RSNA. Ketryx's acclaimed webinar series continues to draw interest from regulated teams with best practices and education on the latest FDA guidance, including PCCP, cybersecurity guidance, and total product lifecycle management.

2025 Predictions

Ketryx anticipates the following trends shaping the MedTech landscape in 2025:

• AI Integration as Standard Practice: By 2025, all major MedTech manufacturers will have AI-enabled products in their portfolios. The Ketryx platform helps manufacturers ensure these innovations are compliant and secure.
• Accelerated Software Updates: Weekly or monthly software updates will become more common in MedTech, requiring companies to adopt tools that balance speed with reliability.

"The MedTech industry is undergoing rapid changes," said Kaminski. "Our work in 2024 positioned Ketryx as a trusted partner for companies navigating these shifts, and we are prepared to support them through the challenges and opportunities of 2025."

AI Webinar Series

Join us for our AI webinar series on the challenges and opportunities of regulated AI. Our next webinar is on Wednesday, January 15, at 11 am ET: "Navigating the FDA's Total Product Lifecycle Framework for Generative AI Devices."

Generative AI devices hold transformative potential for healthcare, but ensuring their safety and effectiveness demands robust lifecycle management strategies. Building on the FDA's Total Product Lifecycle Considerations for Generative AI-Enabled Devices, this session provides actionable insights to help you align with regulatory expectations while driving innovation.

Register here.

About Ketryx

Ketryx is the first and only Al-powered connected lifecycle management platform for the life sciences industry. Our automation-based software enables companies building regulated software to accelerate development through modern cloud-based tools while improving quality and compliance. By overlaying and connecting existing product development and quality tools, Ketryx creates a real-time, traceable, single source of truth. Teams expedite time to market by automating documentation while enforcing SOPs across connected systems.

SOURCE Ketryx