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Security & Regulatory

Local AI processing, protected patient data, and a commitment to meet regulatory standards.
Fetoly is a medical software device: it is certified in the US (K251368) and Europe (CE0197) for the fetal heart and brain real-time analysis
Fetoly is Secure

Your Data. Your Control. 100% Secure.

Fetoly operates without internet or cloud dependency, ensuring that your data never leaves your hospital. No external access, no compromises, complete security, privacy, and compliance with data privacy regulations.

Your Security Seatbelt for Every Scan.

Every ultrasound frame of your scan matters. Fetoly analyzes your live exam in real-time, serving as a security seatbelt: providing instant feedback and ensuring no critical detail is overlooked, enhancing your screening accuracy without disrupting your workflow.
Scan exactly as you always do
No workflow changes. No predefined sequence. No constraints on probe movement.
CE 0197 Marked and FDA Cleared
Trusted by clinicians across 20+ countries and supported by leading healthcare partners.
Local & Secure Processing
Our AI is embedded directly within a standard tablet. No cloud processing, meaning top-level privacy and ultrafast performance.
Reports are transferred only at your discretion, with seamless integration into your existing PACS workflow.

Fetoly™

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Smarter Ultrasound for Better Outcomes

Discover how real-time AI can help you detect more and miss less without changing the way you scan