Amsterdam-based startup Lapsi Health is setting a milestone in medical technology by combining artificial intelligence with traditional clinical devices. Its latest breakthrough, the digital stethoscope called Keikku, has received approval from the U.S. Food and Drug Administration (FDA), positioning it as a Class IIA medical device. This new gadget not only performs the conventional functions of a stethoscope, but also captures biometric data and processes it through AI algorithms to offer advanced support in medical diagnosis.
IA and real-time diagnostics
The Keikku, whose name means "child" in Finnish, was initially conceived to aid in the detection of childhood asthma, but its scope has expanded considerably. This device aims to assist healthcare professionals in monitoring chronic diseases of the heart and lungs through acoustic processing and other built-in sensors. One of the next advances Lapsi hopes to implement in the Keikku is the detection of heart murmursthrough AI, a feature already found in some competing devices such as Eko Health's digital stethoscopes. Lapsi plans to obtain FDA clearance for these advanced AI features through the 510(k) process, which allows for accelerated certification of medical devices with technological innovations. According to Lapsi co-founder and CEO Jhonatan Bringas Dimitriades, the device is not designed to automate diagnostics, but toprovide more effective clinical support by analyzing biometric data, which will facilitate decision-making in the clinical setting.
Innovation in remote monitoring
The Keikku is also designed to be used at home as part of remote monitoring programs in collaboration with medical teams. Thanks to its extensible design, the device will be able to be upgraded via software to add new functionality as Lapsi develops more sophisticated algorithms. In addition, the startup is already working on a second generation of this hardware, expected by the end of 2025, which will include additional sensors such as a PPG (photoplethysmography), accelerometers, gyroscopes and proximity sensors. These components will enable the collection of optical information, such as blood flow, and provide more complete data for diagnosis. Another of Lapsi's planned innovations is a wearable device called Ilo, aimed at pregnant women. This acoustic sensor will monitor the heartbeat and movements of the fetus, functioning as an early warning system for possible complications. This product would be the first of its kind and is scheduled to be launched in 2026, after obtaining regulatory approval.
IA and the future of medical diagnostics
Lapsi Health has developed a unique approach by combining the traditional listening function of stethoscopes with advanced data capture and processing capabilities. Its hardware architecture, called GPHA (general purpose hardware), is designed to be flexible and adaptable, allowing new functionality to be added without the need to modify the physical device. This system not only captures sounds, but also collects other biometric data that is processed and cleaned by the company's proprietary algorithms, making it ready for AI analysis. Lapsi's vision goes beyond just improving current medical devices. Like Tesla with its autonomous vehicles, the company seeks to leverage AI to offer a more holistic approach to medical care, but without replacing human medical decision-making. Instead, the technology is used to speed up diagnoses and improve accuracy, something that could change the way healthcare is delivered globally. With this combination of AI and advanced medical technology, Lapsi Health is at the forefront of a new era of smart healthcare devices. The potential of these advances lies not only in facilitating the work of healthcare professionals, but also in empowering patients to track their health more closely from the comfort of their homes.
