The consumerization of medtech marches on: Amsterdam-based startup Lapsi Health has just clinched FDA approval for its first clinical support tool, a digital stethoscope. The U.S. medical devices regulator, the Food & Drug Administration, has cleared it as a Class IIA (medium risk) medical device.

The startup’s debut sensing gadget is called Keikku, which means child in Finnish. It is a reference to the company’s original focus on support for detecting childhood asthma. But the smooth, puck-shaped touch-sensitive sensing hardware is intended as the first of a portfolio of devices and wearables that will be pitched, initially, at general healthcare professionals.

Lapsi’s forthcoming devices will aim to support the monitoring of chronic heart and lung conditions, based on acoustic processing and data from other on-board sensors.

It’s also set to target a future device at parents-to-be: This novel wearable (to be called Ilo) will be aimed at pregnant women. When placed on the belly, it will use acoustic processing and on-board sensors to track the heartbeat and movements of the developing fetus as an early warning system for potential problems. The startup claims this device will be a world first.

Big acoustic ambitions

The young medtech business has kicked off with the cardinal doctor’s tool (what’s more familiar than a stethoscope?). It is upgrading the conventional tool from an analogue listening device to a data-capturing digital platform play so it can become a fully fledged health tracker. In particular, it adds features that will be familiar to the average tech consumers, such as the ability to record digital sound clips, open a secure comms channel and stream data in the process. Its roadmap encompasses a more ambitious range of healthcare support aims.

To this end, a forthcoming second-gen version of Lapsi’s hardware platform — slated for launch by the end of 2025 — will include more sensors than the technology powering Keikku to open up a wider range of opportunities in diagnostics.

It also hopes to be able to expand Keikku’s capabilities sooner via software updates. They will bolt-on AI-based analysis, if it manges to gains FDA approvals for specific features — starting with heart murmur detection (something we’ve seen on rival medtech Eko’s digital stethoscope since 2022).

Lapsi is applying for clearance for that feature through the FDA’s 510(k) route and is anticipating that being granted by the end of the year. And it expects more clearances and capabilities to follow on from there. Co-founder and CEO Jhonatan Bringas Dimitriades emphasizes that its core hardware is extensible by design.

“Our mission is to unlock the health opportunities and the unprecedented insights that sound has,” he tells TechCrunch, discussing the focus the startup has honed since being founded in late 2021. From a tool for tracking childhood asthma it’s mapped out a wide-ranging platform play for supporting multiple healthcare needs.

“We have a patented, general purpose hardware architecture,” he says, stressing the way-paving the team has undertaken since these physicians and engineers got to work. Including — most recently — having three (of multiple) pending patents granted in the EU.

“We have created this PCB [printed circuit board] that looks like a chipset, or is a compendium of chipsets… and it has multiple sensors inside. It’s not only microphones… We call it GPHA — general purpose [hardware] — because it gives us raw data.”

Lapsi then uses proprietary software algorithms to process and clean up the data — and “get it ready for AI,” as Bringas Dimitriades puts it.

Its software platform is designed to take all this raw biomarker data and interpret it via algorithmic analysis, outputting medical insights to support healthcare professions. Lapsi also envisages Keikku being provided to patients so they can carry out remote monitoring at home in conjunction with their care team.

He likens Lapsi’s approach to Tesla’s platform play — i.e. where the carmaker is shooting to commercialize fully autonomous car tech. Although he suggests it isn’t intending its AI-aided devices to automate diagnosis. The kit will stay in a care support lane but gain in capability and functionality.

The second generation of Lapsi’s hardware platform will underpin the ambition, enabling the gen-two Keikku and all future devices/wearables to pack a sensing array that includes not just sound (via the staple on-board microphone) but also a PPG (photoplethysmography) sensor, an accelerometer, a gyroscope and a proximity sensor — so they can capture optical information using light to gather physiological signals such as blood flow and other data-points, too.

Bringas Dimitriades won’t publicly discuss where the startup obtained training data for honing its data processing algorithms, such as a forthcoming wheeze and crackle tracking AI (for respiratory conditions), saying it’s confidential. But he claims the data sets they’re using are appropriately diverse for sound-led diagnostics, an area of medicine where he suggests differences in age and gender are the most important characteristics when it comes to understanding variance in how biologically produced sounds can change across bodies (whereas, he says, ethnic diversity is less important in this context).

Turning back to Lapsi’s first device, it’s designed a touch- and gesture-based interface for controlling the digital stethoscope. This means there’s no need for any mechanical buttons or ports on the hardware itself. Bringas Dimitriades says it wanted Keikku to have pure, clean lines as traditional stethoscopes can harbor lots of germs.

So, for instance, to increase the volume the user just needs to twist the puck. The connected device also uses wireless charging to juice up the built-in battery so no need to plug it in. Bluetooth is also on-board so it can be paired with connected headphones. Tapping Keikku lets the user instigate various functions.

Lapsi will be marketing the kit directly to healthcare professionals, starting with U.S.-based practitioners. He says “the stethoscope is the only device in healthcare that is purchased directly by its user” — dubbing it akin to “a chef’s knife”. So far they’ve had 1,700 pre-orders for the device.

But given the need for users to learn a new digital knob twiddling interface, isn’t Lapsi concerned potential customers may not be keen to go through the touch- and gesture-based learning curve? Bringas Dimitriades says not. He reckons the general medicine professions it’s targeting — who are generally aged 25 to 50, with also a majority being women — are plenty savvy when it comes to consumer tech and unlikely to be fazed by learning how to pair and steer another digital gizmo. It has also run usability tests in the U.S. with good results.

“We have developed a very simple to use and easy to use medical device that can fit into multiple modes of clinical usage,” he argues. “Also that can be used by patients on telemedicine and remote management. It’s not only about the shape or the design or the functions or the cutting edge technologies we’ve used or the sound experience. It’s basically everything at once,” Bringas Dimitriades said.

“We have created a technology in which, when you just press one button to stream a sound, you not only just go and stream the sound itself, but you also go into a sort of WhatsApp call that we have encrypted inside of our architecture, and what it does is it basically creates an entire telemedicine session in one click,” he also tells us, fleshing out one of the built in streaming and sharing features.

Such features could help speed up patient care by enabling a GP to loop in a consultant for an expert verdict on a particular biomarker, he suggests. “If you go to hospital with chest pain and they do you an ECG, the next doctor in the next shift will grab your ECG, read it and do you another one and compare them. That is how evidence based medicine works, but not in sound,” he argues, adding: “It’s our responsibility to build a platform in which we can actually use it in the most objective way for the sake of the patients.”

Racing to compete in premium medtech

The Keikku will go on sale to healthcare professionals in the U.S. imminently, per Bringas Dimitriades, at a price point ($350) that’s far above the cost of an analogue stethoscope. But it sits in a similar ballpark to rival Eko Health’s digital stethoscopes.

Eko has been working in this area for considerably longer than Lapsi and has also pulled in many millions more in investment. Lapsi has raised just $5.8 million to date across pre-seed and seed fundings (Texas-based Modi Ventures is its lead investor) — which includes $1.4 million worth of scientific grants. Comparatively, Eko’s raised a total of $165 million when it announced its Series D this summer.

Bringas Dimitriades says one of the startup’s next steps, post Keikku launch, will be turning its attention to raising a Series A. It’ll be targeting a round of $10 million for the first half 2025 (if not before).

Despite starting from a better funded veteran like Eko, Bringas Dimitriades talks up how much development Lapsi has packed into just “two years, eight months” of startup life. He suggests it’s developing novel medtech at a faster clip than others thanks to a talent-heavy team — which features both medtech expertise and consumer health tech smarts. For example Lapsi’s engineering lead, Toni Leinonen, was a founder at Finnish Internet of Things veteran Haltian where he led development of the Oura health-tracking smart ring through a partnership arrangement with that device maker.

With its hardware architecture, it wants to offer “the most comprehensive suite” for monitoring patients with structuring heart conditions or lung conditions, he also says, emphasizing the scope of the ambitious platform play they’ve devised.

Though, as with any medtech, how fast it can run is not entirely in its control as launches must wait on FDA approval — which, in the case of Lapsi’s more novel technologies (such as fetal monitoring) are more likely to take years than months to gain. For instance, Lapsi is penciling in 2026 to get clearance for Ilo, per Bringas Dimitriades.

Meanwhile, once AI-powered feature updates for Keikku have been cleared — such as heart murmur detection, and wheeze and crackle tracking for respiratory conditions — he says they’ll aim to get them out to users as quickly as possible.

“By medio 2025, or the third quarter of 2025, we should have three algorithms ready in the Keikku platform. And by the end of 2025 we should launch Keikku generation two,” he adds.