Lapsi Health's sound diagnostics device Keikku receives FDA Class II clearance

Healthcare startup Lapsi Health has announced that its newest innovation, Keikku, has received FDA Class II clearance, setting the stage for its US launch.

Founded in 2022, Lapsi Health aims to enhance remote healthcare provision by allowing clinicians to use a catalogue of clinical stethoscope ausculatory sounds — for example breathing sounds in the lungs —  to screen, monitor and treat patients away from the clinic.

Unlike traditional stethoscopes, Keikku transforms the simple act of listening into a data-rich moment, paving the way for advanced AI-driven analytics in multiple care fields, including cardiac, respiratory, gastrointestinal, and obstetric diagnostics. 

Designed for every HCP in healthcare, Keikku makes spotting potential issues faster and more accessible, thanks to the multiple data functions in its software architecture. From streaming to sharing, to its wireless nature, the device empowers frontline clinicians without overburdening them with complex tech.

The company's founders are Jhonatan Bringas Dimitriades, MD (CEO), Diana van Stijn, MD PhD (Chief Medical Officer), Seamus Holohan (COO), and Rodrigo Alvez (CTO).

According to Dr Diana van Stijn, MD, Chief Medical Officer of Lapsi Health:  

“Sound has always been key in diagnostics, but with Keikku, we’re turning it into actionable data that can revolutionise and empower medical care.”

Since its founding, Lapsi health has 1 patent granted (8 patents pending), ISO certification, two distributors, and over 1,000 pre-orders already secured.

In January the company raised $3.7 million in Seed round led by Modi Ventures, a Texas-based Venture Capital fund. 

While the first-generation of Keikku focuses on sound-related data, upcoming updates will integrate many sensors for deeper diagnostic insights.

Lead image: Lapsi. Photo: uncredited.