Lapsi Turns Stethoscope into a Health Monitoring Platform

A doctor uses Keikku to listen to a patient's lungs.
Consumer focus on medical technology continues to evolve: Amsterdam-based startup Lapsi Health has received FDA approval for its first clinical tool—a digital stethoscope. The device has been registered as a Class IIA medical device (medium risk) by the U.S. Food and Drug Administration.

The company's first product is called Keikku, which means "child" in Finnish. This name reflects the startup's original goal—assisting in the diagnosis of asthma in children. However, the smooth, round digital stethoscope is intended as the initial product in a line of medical and wearable devices to be offered to healthcare professionals.

Future Lapsi products will target monitoring chronic heart and lung diseases using acoustic processing and data from other built-in sensors.

The company also plans to develop a new device named Ilo, aimed at expectant mothers. This wearable device, placed on the belly, will use acoustic processing and built-in sensors to monitor fetal heartbeats and movements, providing early warnings of potential problems. Lapsi claims this device will be the first of its kind.

Acoustic Ambitions at New Heights
The med-tech startup began by modernizing the traditional doctor's tool—the stethoscope—transforming it from an analog device into a digital platform for health data collection. This will allow for a comprehensive health tracker with features familiar to users of modern technology, such as audio file recording, secure communication, and data streaming. Lapsi's roadmap encompasses a broad spectrum of ambitious goals in healthcare support.

The planned second version of Lapsi's hardware, set to launch in late 2025, will include more sensors than the current version of Keikku, expanding diagnostic capabilities.

The company hopes to enhance Keikku through software updates, including the addition of AI analyses, pending FDA approval for specific features like heart sound detection, already implemented in competitor Eko's digital stethoscope since 2022.

Lapsi has filed for approval for this feature via the FDA's 510(k) route and expects to receive it by year-end. Further approvals for new functionalities are also anticipated. Co-founder and CEO Jonathan Bringas Dimitriadis emphasizes that their hardware is designed for expansion.

"Our mission is to unlock the potential of health and the new ideas that sound brings," he noted in an interview with TechCrunch, sharing the focus the startup has maintained since its founding in late 2021. From a tool for monitoring childhood asthma, the company has evolved into a comprehensive platform supporting various healthcare needs.

"We have a patented general-purpose hardware architecture," he added, discussing the team's progress since the startup's inception. Currently, they have three patents pending in the EU.

"We developed a circuit board that consists of multiple chips and sensors. It's not just microphones... We call it GPHA—general-purpose hardware because it provides raw data."

Afterward, Lapsi applies its own algorithms to process and clean the data, preparing it for analysis with AI, as Bringas Dimitriadis explains.

Lapsi's software platform is designed to work with these raw biomarker data, interpreting them through algorithmic analysis and providing medical insights to support healthcare workers. Lapsi also plans to provide Keikku to patients for remote monitoring of their conditions at home in collaboration with their medical team.

The company compares its approach to Tesla's platform model, meaning the automaker strives to commercialize fully autonomous technologies. However, they do not plan to use their AI-enabled devices for automating diagnosis. The devices will remain within the care support framework while acquiring more functions and capabilities.

The second version of Lapsi's hardware will support these ambitions, allowing Keikku and future devices/wearables to use a sensor matrix, including not only sound (via a built-in microphone) but also photoplethysmography (PPG), accelerometers, gyroscopes, and proximity sensors for capturing optical information using light, enabling the collection of physiological data like blood flow.

Bringas Dimitriadis does not disclose where the startup obtained data to train its processing algorithms, such as the upcoming AI for tracking wheezes and crackles (in respiratory diseases), stating that this is confidential information. However, he emphasizes that the datasets they use are diverse enough for sound-based diagnostics, where age and gender differences play a crucial role in understanding sound changes in different bodies.

A Tool for Tech-Savvy Healthcare Professionals
Returning to Lapsi's first device, the company developed a touch interface to control the digital stethoscope. This means there are no mechanical buttons or ports on the device itself. Bringas Dimitriadis notes that Keikku features a clean and simple design, as traditional stethoscopes can harbor many microbes.

To increase the volume, users simply turn a dial. The connected device also supports wireless charging, eliminating the need to plug it into a socket. Built-in Bluetooth allows the device to connect to headphones. Pressing Keikku launches various functions.

Lapsi will sell the device directly to healthcare professionals, starting with primary care physicians in the U.S. Bringas Dimitriadis claims that "the stethoscope is the only medical device that its user buys directly," referring to it as a "chef's knife." So far, they have 1,700 pre-orders for the device.

Considering the need for users to learn a new digital interface, is Lapsi concerned that potential customers may be reluctant to go through a learning curve? Bringas Dimitriadis does not see this as a problem, noting that the target audience—healthcare workers aged 25 to 50, mostly women—are tech-savvy enough to master another digital device. He also conducted usability tests in the U.S. with positive results.

"We developed a very simple and user-friendly medical device that can be used in various clinical settings," he asserts. "Moreover, it can be used by patients in telemedicine and remote monitoring. It’s not only about form and function, but also about the high technology we applied."

"We created a technology where, by pressing one button to stream sound, you not only start streaming but also transition to a kind of call that we encrypted in our architecture, creating an entire telemedicine session with one click," he explains, describing one of the streaming and sharing features.

These capabilities could help accelerate patient care, enabling a general practitioner to connect with a consultant for expert opinions on specific biomarkers. "If you come to the hospital with chest pain and have an ECG done, the next doctor on shift will compare your ECGs. That’s how evidence-based medicine works, but not in the sound aspect," he adds, emphasizing: "Our task is to create a platform where we can use it as objectively as possible for patients."

Competition in Premium Med-Tech
According to Bringas Dimitriadis, Keikku will be available for healthcare professionals in the U.S. soon, priced at $350, significantly higher than traditional stethoscopes but on par with digital stethoscopes from Eko Health.

Eko has been in this field much longer and has raised significantly more funding—many millions more. So far, Lapsi has raised $5.8 million in seed and pre-seed funding, led by Texas-based Modi Ventures, including $1.4 million in scientific grants. Meanwhile, Eko raised $165 million in its recent Series D round and aims to outpace the Lapsi startup in terms of patient data and hardware.

However, Lapsi has already presented its product with high quality and innovative value and has a strategy for further expansion.

"Our goal is to support a healthy lifestyle and focus on prevention rather than treatment," concludes Bringas Dimitriadis, emphasizing that this is the foundation of their philosophy.