Lapsi Health Launches Keikku 2.0, the First FDA-Cleared Digital Stethoscope with Integrated AI Scribe
Amsterdam-based Lapsi Health has announced the launch of Keikku 2.0, a next-generation digital stethoscope that combines AI-powered auscultation, automated clinical documentation, and real-time diagnostic support in a single device. The product marks the world’s first FDA-cleared stethoscope with an integrated AI scribe, reflecting a step forward in how clinicians record, analyze, and act on patient data.
Designed by physicians, Keikku 2.0 aims to reduce administrative burden and enhance diagnostic efficiency. According to the American Medical Association, physicians in primary care spend an average of 36 minutes per patient visit on electronic health record (EHR) charting, often outside regular hours. Keikku 2.0 addresses this challenge by automatically generating structured, ready-to-use clinical notes that integrate with major EHR systems. The device also supports interoperability with leading scribe technologies and ensures data security through advanced encryption and HIPAA-compliant protocols.
Beyond documentation, Keikku 2.0 incorporates multiple sensors and AI algorithms to analyze cardiac and pulmonary sounds, detecting abnormalities such as murmurs or irregular lung patterns. By converting sound into structured data, the device offers clinicians immediate insights during physical exams. Its high-definition ambient microphones maintain diagnostic accuracy even in noisy environments, while secure data transmission safeguards patient privacy.
Lightweight and wireless, the Class II medical device operates via Bluetooth and pairs with a smartphone, with future iterations expected to support independent functionality. Its portability allows clinicians to use it seamlessly during hospital rounds, outpatient visits, or field care, functioning as a compact, intelligent assistant that complements routine medical workflows.
Dr. Diana van Stijn, Chief Medical Officer and co-founder of Lapsi Health, said the device was developed to “fit naturally into clinical workflows” and to “reduce stress for healthcare providers.” CEO and co-founder Dr. Jhonatan Bringas Dimitriades added that the goal is to give physicians “less time on paperwork and more focus on patients.”
With Keikku 2.0, Lapsi Health bridges clinical and digital innovation, positioning AI-assisted auscultation as a practical, everyday tool for modern healthcare environments.
