LAPSI HEALTH'S KEIKKU GETS FDA CLASS II CLEARANCE AND LAUNCHES IN THE U.S. WITH PRE-ORDERS AND A PIPELINE FULL OF OPPORTUNITIES

AMSTERDAM, Oct. 1, 2024 /PRNewswire/ -- Lapsi Health, a fast-growing healthtech startup from Europe and the U.S., has announced that its newest innovation, Keikku, has received FDA Class II clearance, setting the stage for its U.S. launch.

With over 1,000 pre-orders already secured, Keikku is positioned to radically transform how healthcare professionals and consumers capture and utilize sound data in diagnostics.

Lapsi means 'child' in Finnish (As the company has Dutch-Finnish roots), Keikku means 'tool'.

Dr. Diana van Stijn, MD, Chief Medical Officer of Lapsi Health, emphasizes the disruptive potential of Keikku: "Sound has always been key in diagnostics, but with Keikku, we're turning it into actionable data that can revolutionize and empower medical care."

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 fields of care, including cardiac, respiratory, gastrointestinal, and obstetric diagnostics. While the first generation of Keikku focuses on sound-related data, upcoming updates will integrate a plethora of sensors for deeper diagnostic insights.

What truly sets Keikku apart is its focus on the forward-thinking, tech-driven healthcare providers—a generation that values not only functionality but also a seamless user experience and a greater sense of agency. 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 sophisticated and easy-to-use platform allows HCPs and patients to manage data in a fast-streamed and purposeful way.

A Future-Forward Vision for HealthTech

Lapsi Health's vision is to democratize access to the insights of our body through sound, combining proprietary hardware with AI to disrupt the traditional medical device market. Keikku is the first step in their broader mission to develop a suite of healthcare tools that are portable, accessible, and seamlessly integrated with AI-powered insights.

About Lapsi Health

Lapsi Health was founded by Jhonatan Bringas Dimitriades, MD (A Dutch-Peruvian Physician), Diana van Stijn, MD PhD (Dutch Physician), Rodrigo Alvez, MBA (Uruguayan Technologist), and Seamus Holohan (Irish-Finnish Entrepreneur)

With USD 5.8 million raised to date and backed by Modi Ventures, Lapsi Health is primed to lead the charge in creating the next generation of medical devices. The FDA clearance and upcoming U.S. launch of Keikku are just the beginning for this ambitious startup.

For more information, visit www.lapsihealth.com.

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SOURCE Lapsi Health