FDA-Approved Dutch-Finnish AI-Powered Digital Stethoscope Keikku

FDA-Approved Dutch-Finnish AI-Powered Digital Stethoscope Keikku

Dutch-Finnish startup Lapsi Health has recently received U.S. Food and Drug Administration (FDA) clearance for its innovative digital stethoscope, Keikku. Unlike traditional models, Keikku transforms the act of listening to bodily sounds into a sophisticated data capture moment, leveraging advanced AI-driven analytics across multiple healthcare sectors, including cardiology, pulmonology, gastroenterology, and obstetrics.

While Keikku’s current iteration primarily focuses on sound-based diagnostics, future versions will incorporate an expanded range of sensors designed to gather additional biometric data, potentially setting new standards for AI in diagnostic support. Already, Lapsi Health has secured over 1,000 pre-orders, underscoring the high demand and interest in its pioneering technology.

“Sound has always played a crucial role in diagnostics, but Keikku turns it into actionable, data-driven insights that could significantly enhance medical care,” said Lapsi Health’s Chief Medical Officer, Dr. Diana van Stijn.

Keikku’s design prioritizes accessibility for all healthcare professionals, offering streamlined data-sharing capabilities, wireless functionality, and a user-friendly interface to support clinicians at the point of care. With its potential to simplify diagnostics while delivering more accurate results, Keikku is positioned as a powerful tool for both primary care and specialized practitioners.

Lapsi Health envisions Keikku as the initial step toward democratizing access to advanced diagnostic insights through AI-integrated sound analysis. By blending proprietary hardware with cutting-edge AI algorithms, the company aims to disrupt the medical device landscape. Founded by Dr. Stijn, Jhonatan Bringas Dimitriades, M.D., Rodrigo Alvez, and Seamus Holohan, the Netherlands-based startup has raised $5.8 million with backing from Modi Ventures, aiming to redefine portable medical tools and set new standards for accessibility and functionality in diagnostic devices.




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