Lapsi Health’s Keikku Gets Fda Class Iia Clearance And Launches In The U.s. With Pre-orders And A Pipeline Full Of Opportunities

Top Quote Lapsi Health, a healthtech startup based in the Netherlands and the USA, has officially received FDA Class IIA Clearance for Keikku, its newest medical innovation. Lapsi Health’s patented sound+AI platform is designed to create new opportunities in diagnostics, transforming how biometric data is acquired and analyzed. End Quote
  • (1888PressRelease) October 02, 2024 - Amsterdam, The Netherlands – Lapsi Health, a healthtech startup based in the Netherlands and the USA, has officially received FDA Class IIA Clearance for Keikku, its newest medical innovation. Lapsi Health’s patented sound+AI platform is designed to create new opportunities in diagnostics, transforming how biometric data is acquired and analyzed. With over 1000 pre-orders secured, Keikku blends advanced sound processing technologies, a future of AI analytics, and a sleek, high tech design of consumer electronics, offering practitioners a tool that feels as intuitive as it is powerful.

    Dr. Diana van Stijn, MD, Chief Medical Officer at Lapsi Health, emphasizes the device’s potential: “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.

    About Lapsi Health:
    Lapsi Health is a venture backed health-tech company focused on leveraging AI and sound analytics to enhance diagnostic opportunities in healthcare. With a total investment to date of USD 5.8 million, including USD 1.4 million in scientific grants, the company is dedicated to democratizing the use of sound insights both in and out of clinical settings. Lapsi Health’s latest investment round was led by Houston-based venture capital firm, Modi Ventures. Founded by a team of physicians and engineers, Lapsi is committed to creating innovative products that bridge the gap between medicine and technology.

    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).

    Learn more about Lapsi Health at www.lapsihealth.com

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