Medtech is becoming more and more consumerized: The FDA has now approved Lapsi Health, an Amsterdam-based business, for its first clinical assistance tool—a digital stethoscope. The Food and Drug Administration of the United States has approved it as a Class IIA (medium risk) medical device.
The Finnish word for child refers to Keikku, the company’s first sensing device. It alludes to the business’s initial emphasis on providing assistance in identifying childhood asthma. However, the puck-shaped, smooth touch-sensitive sensing technology is meant to be the first in a line of wearables and devices that are targeted first at general healthcare practitioners.
Based on information from several on-board sensors and acoustic processing, Lapsi’s upcoming devices will help monitor long-term heart and lung diseases.
It’s also planned to aim a future gadget at soon-to-be parents: Pregnant women are the target market for this innovative wearable, which will be dubbed Ilo. As an early warning system for possible issues, it will track the growing fetus’s movements and heartbeat when it is put on the abdomen using on-board sensors and sound processing. According to the firm, this gadget will be the first in the globe.
High Goals For Acoustics
What better way to launch a fledgling medical technology company than with the staple instrument of physicians—a stethoscope? In order to transform the traditional equipment into a fully functional health tracker, it is being upgraded from an analog listening device to a data-capturing digital platform play. Specifically, it includes capabilities that the typical tech consumer will be acquainted with, such the capacity to record digital sound clips, establish a secure communications channel, and stream data while doing so. Its roadmap includes a wider variety of more ambitious goals for healthcare support.
In order to do this, a second-generation hardware platform from Lapsi will be released by the end of 2025 and will include more sensors than Keikku’s technology, which will lead to greater possibilities in the field of diagnostics.
Additionally, it aims to use software updates to accelerate Keikku’s capability expansion. If it is able to obtain FDA approval for particular functions, like as heart murmur detection (which has been available on rival medtech Eko’s digital stethoscope since 2022), they will add AI-based analysis.
Lapsi hopes to have that functionality approved by the FDA by the end of the year after submitting an application under the 510(k) process. And it anticipates that additional clearances and capabilities will come after that. Jhonatan Bringas Dimitriades, co-founder and CEO, highlights that the hardware’s core is extendable by design.
He discusses the focus the firm has refined since being launched in late 2021 with TechCrunch, saying, “Our mission is to unlock the health opportunities and the unprecedented insights that sound has.” It started out as a tool for monitoring pediatric asthma and evolved into a comprehensive platform for addressing various healthcare requirements.
“We have a general purpose hardware architecture that is patented,” he emphasizes, highlighting the advancements the team has made since these doctors and engineers started working together. including, most recently, receiving grants for three (of several) pending patents in the EU.
We have designed this printed circuit board, or PCB, to resemble a chipset or to be a collection of chipsets. and it contains a number of sensors within. It goes beyond just microphones. Because it provides us with raw data, we refer to it as general purpose hardware, or GPHA.
After that, Lapsi processes and cleans up the data using in-house software methods to “get it ready for AI,” as Bringas Dimitriades puts it.
Its software platform is made to collect all of this unprocessed biomarker data and use algorithmic analysis to analyze it, producing medical insights that will help the healthcare industry. Additionally, Lapsi envisions giving patients access to Keikku so they may work with their care team to do remote monitoring from home.
He compares Lapsi’s strategy to Tesla’s platform play, which aims to commercialize fully autonomous vehicle technology. He does, however, imply that the goal of its AI-assisted gadgets is not to automate diagnosis. Although it will remain in the care support lane, the kit will become more capable and functional.
The goal will be supported by the second generation of Lapsi’s hardware platform, which will allow the gen-two Keikku and all upcoming devices/wearables to pack a sensing array that includes sensors for PPG (photoplethysmography), proximity, gyroscope, and sound (via the standard on-board microphone). This way, they can capture optical information using light to gather physiological signals like blood flow and other data-points.
Bringas Dimitriades claims that the information is proprietary and won’t be publicly discussing where the startup got training data for refining its data processing algorithms. Examples of these algorithms include an upcoming wheeze and crackle tracking AI for respiratory diseases. However, he asserts that the data sets they are utilizing are suitably diverse for sound-led diagnostics, a field of medicine in which he contends that variations in age and gender represent the most significant features in terms of comprehending the variability in the ways in which biologically generated sounds can vary amongst bodies (while, he says, ethnic diversity is less important in this context).
An Aid For Tech-Native Medical Professionals
Going back to Lapsi’s original gadget, it was created using a touch-and gesture-based UI to operate the digital stethoscope. This implies that no mechanical connectors or buttons on the hardware itself are required. Bringas Dimitriades claims that because conventional stethoscopes can harbor a lot of bacteria, the company intended Keikku to have pure, clean lines.
For example, all the user has to do is spin the puck to boost the volume. In order to recharge the integrated battery of the linked gadget without requiring a plug, wireless charging is also utilized. Additionally, Bluetooth is integrated so that linked headphones can be paired with it. Keikku can be tapped to initiate a variety of functions.
Starting with practitioners located in the United States, Lapsi will promote the kit directly to healthcare providers. He compares the stethoscope to a “chef’s knife,” saying it is “the only device in healthcare that is purchased directly by its user.” 1,700 preorders have been placed for the gadget thus far.
But isn’t Lapsi worried that potential customers might not be eager to go through the touch-and gesture-based learning curve given the necessity for users to become used to a new digital knob-twiddling interface? “No,” responds Bringas Dimitriades. He believes that the target audience for general medicine professions, who are typically between the ages of 25 and 50 and predominantly female, are well-versed in consumer technology and won’t be deterred by having to learn how to pair and operate another piece of technology. It has also successfully conducted usability tests in the United States.
He contends, “We have created a very user-friendly medical device that can be used in a variety of clinical settings.” Additionally, patients can use that for remote management and telemedicine. It goes beyond just the form, the appearance, the features, the state-of-the-art technology we’ve employed, or the audio quality. It’s essentially everything at once, according to Bringas Dimitriades.
He also elaborates on one of the built-in streaming and sharing features, saying, “We have created a technology in which, when you just press one button to stream a sound, you not only 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 proposes that by allowing a general practitioner to consult with a consultant for an expert opinion on a specific biomarker, such characteristics could expedite patient care. “The doctor working the following shift will take your ECG, read it, take another one for you, and compare them if you go to the hospital with chest trouble. That’s the way evidence-based medicine operates, but not in a sound way, he contends, adding that it’s our job to create a framework that will allow us to apply it to patients’ benefit in the most unbiased manner possible.
Competing In The Premium Medical Technology Race
According to Bringas Dimitriades, the Keikku will soon be available for purchase by medical practitioners in the United States for $350, which is significantly more than the price of an analog stethoscope. However, it is comparable to the competing digital stethoscopes from Eko Health.
In addition to having far greater investment in this space than Lapsi, Eko has been operating in this field for a far longer time. With Texas-based Modi Ventures as its principal investor, Lapsi has only raised $5.8 million in pre-seed and seed fundings to yet, which includes $1.4 million in grants for science. In contrast, Eko raised $165 million in total after announcing its Series D this summer.
After Keikku launches, one of Bringas Dimitriades’s next moves for the startup will be to focus on raising a Series A. It intends to raise $10 million in the first half of 2025, if not earlier.
Bringas Dimitriades highlights how much work Lapsi has crammed into just “two years, eight months” of startup life, despite beginning from a more well-funded veteran like Eko. He claims that because of its highly skilled team, which includes both medtech knowledge and consumer health tech acumen, it is creating innovative medtech at a faster rate than others. For instance, Toni Leinonen, the chief engineer of Lapsi, was a founding member of the Finnish Internet of Things pioneer Haltian, where he oversaw the creation of the Oura smart ring, a health-tracking device, as part of a joint venture with that manufacturer.
He adds, highlighting the breadth of the ambitious platform play they’ve developed, that it aims to provide “the most comprehensive suite” for monitoring patients with severe cardiac issues or lung illnesses through its hardware design.
As with any medical technology, however, Lapsi has little control over how quickly it operates because product introductions are subject to FDA approval, which could take years rather than months in the case of Lapsi’s most innovative technologies (like fetal monitoring). For instance, according to Bringas Dimitriades, Lapsi plans to obtain approval for Ilo in 2026.
He said they plan to release AI-powered feature upgrades for Keikku as soon as possible. These updates will include features like heart murmur identification and wheeze and crackle tracking for respiratory diseases.
We want to have three algorithms available on the Keikku platform by the third quarter of 2025, or mid 2025. And we ought to introduce Keikku generation two by the end of 2025,” he continues.