Lapsi Health launches Keikku in Europe following CE MDR Class I certification

Dutch-American clinical AI company Lapsi Health has launched Keikku, its clinical AI platform developed to bring clinical documentation, coding, evidence-based reference, and connected workflows into one environment.

The European launch follows the classification of Keikku Scribe as a Class I medical device under the EU Medical Device Regulation (EU MDR). The platform is now available to clinicians and healthcare organizations across Europe through its web and mobile applications.

What does Keikku offer?

Keikku is designed to address a frequent challenge in clinical AI: healthcare professionals often use separate tools for documentation, coding, research, and electronic health record (EHR) workflows.

The platform brings these capabilities together, including:

• Ambient clinical documentation that converts clinician-patient conversations into structured notes
• Coding Intelligence supporting ICD-10 and other applicable coding workflows
• Contextual clinical reference grounded in more than three million peer-reviewed articles, guidelines, and protocols
• Citations with clinical reference responses so clinicians can review the underlying evidence
• Multilingual documentation for different European care environments
• EHR connectivity and enterprise deployment options
• Clinician review and approval before information is transferred into the medical record

Keikku can be used by individual clinicians or deployed across healthcare organizations, with enterprise features including EHR integration, identity and access management, configurable workflows, SSO and SAML, and implementation support.

A focus on clinical AI and regulatory readiness

The CE MDR Class I classification is a key part of Lapsi Health’s European expansion. The company says its approach is focused on ensuring that healthcare organizations can evaluate clinical AI with greater clarity around safety, quality, transparency, and regulatory readiness.

“European clinicians should not have to become AI auditors before they can benefit from clinical technology.”

He added that Keikku was developed as more than an ambient scribe, bringing together documentation, evidence review, communication, and information transfer within a connected clinical workflow while keeping clinicians in control of outputs.

Built for European healthcare environments

Lapsi Health says Keikku has been designed to support the varied requirements of European healthcare, including multilingual care delivery, GDPR compliance, different health-system structures, and fragmented EHR environments.

The platform combines multilingual documentation, configurable clinical templates, evidence-based reference, enterprise security, and flexible deployment models to support these settings.

With Keikku now available across Europe, Lapsi Health is positioning the platform as a broader clinical AI solution that goes beyond ambient documentation to connect multiple parts of the clinical workflow.

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