Lapsi’s AI-Powered Keikku Stethoscope Transforms Healthcare

Amsterdam-based startup Lapsi Health has secured FDA approval for its first medical device, the Keikku digital stethoscope. Cleared as a Class IIA medical device, Keikku represents the company's initial foray into the medtech market, aimed at transforming the traditional stethoscope into a comprehensive health tracking tool. This approval marks a significant milestone for the young company, which was founded in late 2021.

Revolutionizing Healthcare with Digital Sound and AI

Lapsi’s Keikku digital stethoscope is much more than an upgraded listening device; it’s designed to capture and analyze data to support healthcare professionals in diagnosing and monitoring conditions. Originally developed with a focus on detecting childhood asthma, the puck-shaped device has evolved into a platform that can support a wide array of healthcare needs, including chronic heart and lung conditions.

The device is equipped with acoustic processing and on-board sensors that allow for detailed sound capture. This data can be streamed, recorded, and analyzed, providing real-time insights into patient health. Additionally, Keikku includes features like secure communication channels, enabling doctors to share data instantly with specialists for consultation.

AI Integration and Future Capabilities

Lapsi is actively working on expanding Keikku’s functionality through AI-powered updates. One of the key upcoming features is an AI tool designed to detect heart murmurs. The company is currently seeking FDA clearance for this feature through the 510(k) process, with approval expected by the end of the year. Other AI capabilities, including tracking respiratory conditions like wheezes and crackles, are also in the pipeline.

CEO Jhonatan Bringas Dimitriades emphasized that Keikku’s hardware is designed to be extensible, allowing new features to be added over time without requiring major hardware changes. This modularity ensures that Keikku can stay ahead of evolving healthcare needs while minimizing costs for practitioners.

Advanced Hardware and Future Wearables

Keikku’s design sets it apart from traditional stethoscopes. It features a touch- and gesture-based interface, eliminating the need for mechanical buttons or ports, which can harbor germs. To adjust the volume, users simply twist the device, and its wireless charging capability ensures ease of use. Bluetooth connectivity allows Keikku to pair with headphones, offering a more modern approach to patient care.

Lapsi’s ambitions don’t end with Keikku. The company plans to release a second-generation hardware platform by the end of 2025, incorporating additional sensors to capture more physiological data. These include a photoplethysmography (PPG) sensor, accelerometer, gyroscope, and proximity sensor, which will enable future devices to monitor blood flow and other vital signs.

Proprietary Software and Data Processing

At the heart of Keikku is Lapsi’s proprietary software platform, which processes the raw data collected by its sensors and prepares it for AI-driven analysis. By leveraging algorithms to clean and interpret biomarker data, the platform generates insights that can support healthcare professionals in making informed decisions. This software also enables Keikku to be used for remote patient monitoring, allowing patients to track their health from home in collaboration with their care teams.

“Our mission is to unlock the health opportunities and unprecedented insights that sound has,” said Bringas Dimitriades, discussing Lapsi’s approach to healthcare innovation. The company envisions Keikku as a platform that will provide physicians with more accurate, objective data to improve patient care.

Building a Platform for Healthcare

Lapsi’s approach mirrors that of Tesla’s platform play, where the company aims to continuously enhance the device’s capabilities through software updates rather than relying on hardware upgrades alone. Bringas Dimitriades made it clear that while Keikku’s AI-driven features are advancing, the goal is not to automate diagnoses but to support doctors with enhanced tools and insights.

The future of Lapsi’s product line is ambitious, with plans to release additional devices and wearables aimed at addressing various healthcare needs. One such device, called Ilo, will be targeted at pregnant women, using sensors to monitor fetal heartbeats and movements. The company is eyeing 2026 for FDA clearance of this groundbreaking device.

Competitive Landscape and Funding

Despite its relatively recent entry into the medtech space, Lapsi has made impressive strides. To date, the company has raised $5.8 million, including $1.4 million in scientific grants. While this funding pales in comparison to competitors like Eko Health, which has raised $165 million, Lapsi has managed to develop novel technology in under three years. The company is preparing for a Series A funding round of $10 million by mid-2025 to continue fueling its growth.

With 1,700 pre-orders for Keikku, which is priced at $350, Lapsi is poised to make a significant impact on the digital health market. Although the cost is higher than traditional stethoscopes, it is competitive with other digital models on the market, such as those from Eko Health.

A Rapidly Growing Medtech Player

Lapsi’s success can be attributed to its talented team, which combines medtech expertise with consumer health technology experience. The company’s engineering lead, Toni Leinonen, was previously involved in developing the Oura health-tracking ring, bringing deep knowledge of wearable health tech to the team.

As Lapsi continues to develop new products and features, it faces the challenge of navigating the regulatory approval process. However, with several patents already granted in the EU and more pending, Lapsi is well on its way to achieving its vision of transforming healthcare through sound and data.

The Keikku stethoscope is set to launch soon, with pre-orders already underway for healthcare professionals in the U.S. You can view their live event October 1st, 202409:00 PST / 12:00 EST.