The consumerization of medtech continues to advance as Amsterdam-based startup Lapsi Health has recently secured FDA approval for its first clinical support tool: a digital stethoscope. The U.S. medical devices regulator has classified it as a Class IIA (medium risk) medical device.

Lapsi's initial sensing device, named Keikku—meaning "child" in Finnish—reflects the company's original focus on supporting childhood asthma detection. The sleek, puck-shaped, touch-sensitive device is designed as the first in a series of devices and wearables aimed initially at general healthcare professionals.

Future devices from Lapsi will focus on monitoring chronic heart and lung conditions using acoustic processing and data from other onboard sensors. One upcoming product will target expectant parents: a novel wearable called Ilo, intended for pregnant women. When placed on the abdomen, Ilo will utilize acoustic processing and onboard sensors to track the fetus's heartbeat and movements, serving as an early warning system for potential issues. The startup claims this will be a world first.

### Big Acoustic Ambitions
The young medtech company is enhancing the traditional stethoscope by transforming it from an analog listening device into a data-capturing digital platform, thereby creating a comprehensive health tracker. This upgrade includes features familiar to tech consumers, such as the ability to record digital sound clips, establish secure communication channels, and stream data. Lapsi envisions a broader range of healthcare support in its roadmap.

A second-generation version of Lapsi's hardware platform, expected to launch by the end of 2025, will incorporate more sensors than the technology powering Keikku, expanding diagnostic opportunities. The company also plans to enhance Keikku's capabilities through software updates, including AI-based analysis for features like heart murmur detection, pending FDA approval.

Co-founder and CEO Jhonatan Bringas Dimitriades emphasizes that the core hardware is designed to be extensible. "Our mission is to unlock health opportunities and unprecedented insights that sound provides," he explains, noting the startup's evolution since its founding in late 2021.

### A Tool for Tech-Savvy Healthcare Professionals
Lapsi has created a touch- and gesture-based interface for controlling Keikku, eliminating the need for mechanical buttons or ports that can harbor germs. Users can increase the volume by twisting the puck, and the device supports wireless charging and Bluetooth connectivity for pairing with headphones. 

The kit will be marketed directly to healthcare professionals in the U.S., where the stethoscope is uniquely purchased by its users. So far, Lapsi has received 1,700 pre-orders for the device, priced at $350, which is significantly higher than traditional stethoscopes but comparable to those from competitor Eko Health.

Despite potential concerns about a learning curve for users unfamiliar with digital interfaces, Bringas Dimitriades believes the target audience—healthcare professionals aged 25 to 50, many of whom are women—will be adept with consumer technology. Usability tests in the U.S. have yielded positive feedback.

### Competing in the Premium Medtech Space
Following the launch of Keikku, Lapsi plans to pursue a Series A funding round of $10 million in the first half of 2025. To date, the startup has raised $5.8 million, including $1.4 million in scientific grants, with Texas-based Modi Ventures as its lead investor. In contrast, Eko has raised $165 million since announcing its Series D funding.

Bringas Dimitriades highlights Lapsi's rapid development pace, noting that the startup has made significant strides in under three years. The team combines expertise in both medtech and consumer health technology, with engineering lead Toni Leinonen previously co-founding Haltian, a Finnish Internet of Things company known for the Oura health-tracking smart ring.

Lapsi aims to offer a comprehensive suite for monitoring patients with heart and lung conditions, though the pace of its growth is subject to FDA approval timelines, especially for more innovative technologies like fetal monitoring. The company anticipates clearance for Ilo in 2026 and plans to release AI-powered feature updates for Keikku, such as heart murmur detection, as quickly as possible.

By mid-2025, Lapsi expects to have three algorithms ready for the Keikku platform, with the second generation launching by the end of that year.