AMSTERDAM , Oct. 1, 2024 /PRNewswire/ -- Lapsi Health, a fast-growing healthtech startup from Europe and the U.S.

, has announced that its newest innovation, Keikku , has received FDA Class II clearance , setting the stage for its U.S. launch.

With over 1,000 pre-orders already secured, Keikku is positioned to radically transform how healthcare professionals and consumers capture and utilize sound data in diagnostics. Lapsi means 'child' in Finnish (As the company has Dutch-Finnish roots), Keikku means 'tool'. Dr.

Diana van Stijn , MD , Chief Medical Officer of Lapsi Health, emphasizes the disruptive potential of 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." Unlike traditional stethoscopes, Keikku 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.

What truly sets Keikku apart is its focus on the forward-thinking, tech-driven healthcare providers —a generation that values not only functionality but also a seamless user experience and a greater sense of agency . Designed for every HCP in healthcare, Keikku makes spotting potential issues faster and more.