The increasing consumerization of medical technology: Amsterdam-based startup Lapsi Health just won FDA approval for its first clinical support tool, a digital stethoscope. The U.S. medical device regulator, the Food and Drug Administration, has approved the product as a Class IIA (intermediate risk) medical device.
The startup's debut sensing gadget is called Keikku, which means child in Finnish. This is a reference to the company's original focus on supporting the discovery of childhood asthma. But the slick puck-shaped touch-sensitive sensing hardware is intended as the first in a portfolio of devices and wearables that will initially be marketed to general medical professionals.
Lapsi's upcoming device aims to support monitoring of chronic heart and lung conditions based on acoustic processing and data from other onboard sensors.
Future devices will also be targeted at parents-to-be. This new wearable (called Ilo) is aimed at pregnant women. When placed in the abdomen, it uses acoustic processing and onboard sensors to track heart rate and movement of the developing fetus as an early warning system for potential problems. The startup claims this device is the world's first.
Big acoustic ambitions
This young medical technology business started with a cardinal doctor's tool (what could be more familiar than a stethoscope?). Upgrade your traditional tools to a digital platform play that captures data from analog listening devices, allowing you to become a full-fledged health tracker. In particular, it adds features that will be familiar to the average technology consumer, such as the ability to record digital sound clips, open secure communication channels, and stream data in the process. That roadmap includes a more ambitious range of health assistance goals.
To this end, the upcoming second-generation version of Lapsi's hardware platform, expected to be available by the end of 2025, will incorporate more sensors than the technology that powers Keikku, opening up a wide range of opportunities in diagnostics. It will be opened.
We also want to be able to expand Keikku's capabilities faster through software updates. If they can get FDA approval for certain features, they could start with heart murmur detection (something seen in competing medical technology company Eco's digital stethoscope since 2022) and enhance AI-based analytics. I plan to.
Lapsi has applied for clearance for that feature through the FDA's 510(k) route and expects clearance by the end of the year. And more permissions and features are expected to follow from there. Co-founder and CEO Jonathan Bringas Dimitriades emphasizes that the core hardware is scalable by design.
“Our mission is to unlock the health opportunities and unprecedented insights of sound,” he told TechCrunch, discussing the focus the startup has honed since its founding in late 2021. Platform play to support multiple medical needs.
“We have a patented, general-purpose hardware architecture,” he said, emphasizing that these doctors and engineers have paved the way the team has been working on since they started work. Among them, three patents have been recently granted in the EU (multiple).
“We created this PCB [printed circuit board] It looks like a chipset, or an overview of a chipset… and there are multiple sensors inside. Not just a microphone…we call it GPHA (General Purpose) [hardware] — Because you get the raw data. ”
Lapsi then uses proprietary software algorithms to process and clean the data, making it, as Bringas Dimitriades says, “ready for AI.”
Its software platform is designed to take all this raw biomarker data, interpret it through algorithmic analysis, and output medical insights to support healthcare professionals. Lapsi also envisions offering Keikku to patients so they can collaborate with their care teams and perform remote monitoring at home.
He likens Lapsi's approach to Tesla's platform strategy, the automaker's efforts to commercialize fully self-driving car technology. However, he indicated that the company has no intention of automating diagnostics with its AI-assisted devices. This kit stays in the care support lane, but with increased capabilities and functionality.
Lapsi's 2nd generation hardware platform supports this ambition, providing 2nd generation Keikku and all future devices/wearables with sensing capabilities that include not only audio (via the classic onboard microphone) but also PPG (photoplethysmography). You can now mount an array. It has sensors, accelerometers, gyroscopes, proximity sensors, etc., and can use light to capture optical information and also collect physiological signals such as blood flow and other data points.
Bringas Dimitriades won't publicly discuss where he gets the training data to hone data-processing algorithms, such as the upcoming AI that tracks wheezing and crackles (for respiratory diseases). . However, he argues that the dataset they are using is suitably diverse for sound-driven diagnostics. In this field of medicine, he suggests that age and gender differences are the most important characteristics in understanding differences in how biologically produced sounds change. (On the other hand, he says, ethnic diversity is less important in this context).
Going back to Lapsi's first device, a touch and gesture-based interface was designed to control the digital stethoscope. This means there are no mechanical buttons or ports required on the hardware itself. Bringas Dimitriades said he wanted Cake to have pure, clean lines because traditional stethoscopes can harbor a lot of bacteria.
So, for example, to increase the volume, the user only has to twist the pack. Connected devices use wireless charging to charge the built-in battery, so you don't need to be connected. It also has Bluetooth so you can pair it with connected headphones. Tap Keikku to launch various features.
Lapsi plans to sell the kit directly to healthcare workers, starting with US-based healthcare workers. “The stethoscope is the only medical device that you buy directly,” he said, calling it similar to a “kitchen knife.” There have been 1,700 pre-orders for the device so far.
But given that users will have to learn the interface to operate the new digital knob, Lapsi worries that potential customers may not be keen to go through a touch- or gesture-based learning curve. Isn't that so? Bringus Dimitriades says that's not the case. He said the company's target population of general health care workers (generally between the ages of 25 and 50, and the majority of whom are women) are fairly savvy when it comes to consumer technology and are able to combine different digital devices. I think it's unlikely that you'll be upset if you learn how to operate it. Usability tests have also been conducted in the United States, with good results.
“We have developed a very simple and easy-to-use medical device that can be adapted to multiple modes of clinical use,” he claims. “Patients receiving telemedicine or remote management can also use this. It doesn't just mean the form, the design, the functionality, the cutting-edge technology used, or the sound experience. It's basically everything. all at once,” said Bringas Dimitriades.
“We've developed a technology that allows you to stream sound with the push of a button, and it not only streams the sound itself, but also initiates a kind of WhatsApp call that we've encrypted within our architecture. And what it does. is basically creating an entire telemedicine session with one click,” he told us while also fleshing out one of the built-in streaming and sharing features.
Such a feature could help speed patient care by allowing general practitioners to loop in consultants for expert judgment on specific biomarkers, he suggested. “If you go to the hospital complaining of chest pain and they do an EKG, the doctor on the next shift will read your EKG and do another EKG to compare. That's how evidence-based medicine works. , it's not healthy,” he asserted, adding, “It's our responsibility to build a platform that actually allows healthcare to be used in the most objective way for patients.”
Race to compete in premium medical technology
Cake will soon be available to medical professionals in the U.S. at a price point that far exceeds the price of an analog stethoscope ($350), Bringas Dimitriades said. But it's about on par with Eko Health's digital stethoscope and competing products.
Eco has been in the field considerably longer than Lapsi and has attracted millions more in investment. Lapsi has raised just $5.8 million in pre-seed and seed funding to date (Texas-based Modi Ventures is the lead investor). This includes $1.4 million worth of scientific grants. In comparison, Echoes raised a total of $165 million when it announced its Series D this summer.
Bringas Dimitriades said that one of the startup's next steps after launching Keikku will be to focus on raising Series A funding. The company is targeting a $10 million round in the first half of 2025 (if not earlier).
Despite starting with a well-funded veteran like Eko, Bringas Dimitriades tells us how much development Lapsi has packed into just “2 years and 8 months” of startup life. He said the company develops new medical technologies faster than others thanks to a deep team with both medical technology expertise and consumer health technology smarts. Suggests. For example, Toni Leinonen, engineering lead at Lapsi, is the founder of Haltian, a Finnish Internet of Things veteran who led the development of the health tracking smart ring Oura through a partnership agreement with the device manufacturer.
With its hardware architecture, the company hopes to offer “the most comprehensive suite” for monitoring patients with structured heart and lung disease, and the ambitious platform they have devised. It emphasizes range.
However, like any medical technology, the launch must wait for FDA approval, so there is not complete control over how quickly it can be done. For Lapsi's newer technologies (such as fetal monitoring), approval is more likely to take years rather than months. To get. For example, according to Bringas Dimitriades, Lapsi is planning to receive ILO approval in 2026.
Meanwhile, once Keikku's AI-powered feature updates, such as heart murmur detection and tracking of wheezing and crackles in respiratory conditions, are complete, the company aims to make them available to users as soon as possible, he said.
“By mid-2025, that is, by the third quarter of 2025, we should have three algorithms ready on the Keikku platform. And we should launch the second generation of Keikku by the end of 2025,” he added .