FDA Clears Lapsi Health’s Digital Stethoscope

Dutch-Finnish startup Lapsi Health has gained U.S. Food and Drug Administration clearance for its new digital stethoscope, Keikku. 

Unlike traditional stethoscopes, Keikku (translated from Finnish as “tool”) transforms the simple act of listening into a data-rich moment, paving the way for advanced AI-driven analytics in multiple fields of care, including cardiac, respiratory, gastrointestinal, and obstetric diagnostics. While the first generation of Keikku focuses on sound-related data, upcoming updates will integrate a plethora of sensors for deeper diagnostic insights, according to the company.
 
Lapsi Health has secured more than 1,000 pre-orders for Keikku.
 
“Sound has always been key in diagnostics, but with Keikku, we’re turning it into actionable data that can revolutionize and empower medical care,” Lapsi Health Chief Medical Officer Diana van Stijn, M.D., said.
  
Designed for every healthcare practitioner, Keikku makes spotting potential issues faster and more accessible, thanks to the multiple data functions in its software architecture, Lapsi Health claims. From streaming to sharing to its wireless nature, the device empowers frontline clinicians without overburdening them with complex tech.
 
The sophisticated and easy-to-use platform allows healthcare practitioners and patients to manage data in a fast-streamed and purposeful way.
 
Lapsi Health’s vision is to democratize access to the body’s insights through sound, combining proprietary hardware with artificial intelligence (AI) to disrupt the traditional medical device market. Keikku is the first step in its broader mission to develop a suite of healthcare tools that are portable, accessible, and seamlessly integrated with AI-powered insights.
 
Lapsi Health was founded by Stijn, Jhonatan Bringas Dimitriades, M.D., Rodrigo Alvez, and Seamus Holohan. With $5.8 million raised to date and backed by Modi Ventures, Netherlands-based Lapsi Health aims to create the next generation of medical devices.