CloudSteth Health Files IPO Prospectus: AI-Powered Auscultation for Maternal and Child Cardiopulmonary Screening

China is the world’s second-largest medical device market, yet domestic medical device companies are confronting numerous novel developments without precedent abroad. While a wave of mergers and acquisitions (M&A) has swept the global medical device industry, the number of Chinese medical device enterprises has continued to grow, implying that a significant number of these firms will ultimately be acquired or cease to exist. Nevertheless, challenges also bring opportunities. As target markets shift, primary care institutions have emerged as a major market segment beyond tertiary hospitals, offering medical device companies new avenues for market entry. Furthermore, with the advent of the Internet of Things (IoT) and big data era, intelligent medical devices represent another key breakthrough area.

As a type of high-performance medical device, wearable technology must achieve breakthroughs in core technologies to become a key entry point for the Internet of Things (IoT). It needs to go beyond collecting large volumes of superficial data and instead provide the core clinical data required by physicians, while also overcoming the current homogenization of products. Unlike existing smart wearables that primarily track basic vital signs, YunTing Health focuses on comprehensive health management throughout the maternal and child care continuum. It enables initial screening and auxiliary diagnosis for conditions such as asthma, pneumonia, and heart disease. Through lightweight, intelligent solutions, it empowers consumers to manage their health and monitor diseases using professional-grade methods. For primary healthcare institutions, YunTing Health enhances the efficiency of early warning, diagnosis, and prognosis through more intelligent approaches.

For children aged 0–5, YunTing Health’s ChildCare YunTing Smart Stethoscope, integrated with the YunTing Health Platform, intelligently analyzes patients’ heart and lung sounds to screen for conditions such as asthma, pneumonia, and cardiac diseases. It transforms physicians’ auscultation expertise into visualized heart and lung sound waveforms with diagnostic prompts via patented algorithms, and displays quantitative health index results.

Pneumonia is a major threat to children's health. Infants and young children are more susceptible to pneumonia during the winter and spring seasons. If not thoroughly treated, the condition is prone to recurrent episodes, which can lead to various severe complications.

When cardiopulmonary diseases occur, in addition to heart sounds and breath sounds, the stethoscope detects additional abnormal sounds, namely cardiac murmurs and pulmonary rales. The YunTing intelligent stethoscope can identify cardiac murmurs as well as dry and wet rales, enabling analysis of cardiopulmonary status during the early stage of disease, treatment phase, and recovery period. It performs real-time intelligent analysis to provide parents with effective data for informed decision-making.

Yunting Health was founded in 2015. Three years on, in addition to continuously optimizing its existing products, the company is launching a smart abdominal belt designed for pregnant women. This flexible wearable device monitors fetal heart rate and movement, as well as the mother’s health status.

In addition to consumer-grade products, Yunting Health has launched medical-grade products tailored for healthcare institutions. Within the vast market of healthcare institutions, as tiered diagnosis and treatment systems are advanced, grassroots medical facilities are experiencing a growing demand for auxiliary diagnostic medical devices, surpassing that of tertiary Grade A hospitals.

For consumers, smart stethoscopes cater to users with higher expectations for child-rearing. However, for medical institutions, Cloud Stethoscope Health addresses the needs of primary healthcare facilities in western China, particularly in Tibetan areas. Due to the dispersed population and high prevalence of cardiopulmonary diseases in these regions, disease diagnosis rates remain low. Primary healthcare facilities require portable smart devices to enhance diagnostic and treatment services, thereby providing patients with a better medical experience.

Currently, Yunting Health promotes its remote cardiopulmonary disease screening services to primary healthcare institutions by charging service fees. Meanwhile, Yunting Health also collaborates with non-profit organizations to provide services in Tibetan regions.

In the realm of maternal health monitoring, YunTing Health has introduced a smart abdominal support belt that differs from traditional fetal heart rate monitors. Conventional fetal monitors acquire fetal heart signals using ultrasound principles; however, ultrasound exposure poses certain risks to the fetus, generally limiting usage to no more than 10 minutes per session. In contrast, YunTing employs passive auscultation technology, which only receives biological signals emitted by the human body without emitting any radiation or ultrasound waves, thereby alleviating concerns for expectant mothers.

It is worth noting that overseas markets are also a primary market for YunTing Health. Liu Tao, co-founder of YunTing Health, stated, “Our product sales on Amazon and eBay are comparable to those in China. The main reason is that in some developed countries such as the United States, the United Kingdom, and the Netherlands, nurses have limited prescribing authority, leading to higher demand for auxiliary diagnostic tools, lower market education barriers, and greater product acceptance.”

To truly address parents' needs, it is essential first to amass a large volume of cardiopulmonary sound data, and second, to meet stringent algorithmic requirements.

Yunting Health’s products have obtained the CE Class II medical device certification and accumulated over 20,000 valid cardiopulmonary sound data points. Yunting Health has established collaborations with Shanghai Children’s Hospital and Liaoning Traditional Chinese Medicine Hospital, and is conducting pilot programs in community hospitals in Wuhu City, Anhui Province. With continuous user engagement and conversion, cloud-based data is steadily growing.

In terms of algorithms, Cloud Listening Health has developed machine learning algorithms capable of identifying pulmonary rales, a key clinical indicator for pediatric asthma and pneumonia. These algorithms enable intelligent detection of the presence of rales, as well as their frequency and temporal distribution. Additionally, Cloud Listening Health leverages these algorithms to identify heart murmurs in children, facilitating screening for congenital heart disease.

In addition to child health, YunTing Health is also developing algorithms for maternal health that calculate fetal heart rate and fetal movement counts by collecting fetal heart sound and movement signals. The company is also focusing on identifying uterine contraction signals to enable better and more convenient monitoring of pregnant women’s labor status.

Yunting Health has not only enriched its product portfolio by leveraging its core technologies but also achieved technology export. Liu Tao revealed to VCBeat, “We have currently undertaken several collaborative development projects related to our technology, including the joint research and development of a smart wearable device with a Fortune 500 multinational corporation, and the co-development of the second-generation smart stethoscope with overseas hospitals.”

Zhou Hongyuan, founder of Yunting Health, previously led R&D for large-scale imaging equipment at Neusoft Philips and served at Yinyi Medical, where he was responsible for project implementation and market promotion of major medical projects.

In the future, YunTing Health will leverage its medical device products as a foundation, using screening and early warning for pneumonia, asthma, and congenital heart disease, along with monitoring of fetal heart rate and fetal movement, as entry points. Built on artificial intelligence algorithms and healthcare big data, it will deliver a closed-loop service for comprehensive health management throughout the maternal and infant care journey.

Yunting Health is currently seeking Series A financing. Previously, it received angel investment from Beike Society, and secured Pre-A funding from Hongtai Fund and Gucang Academy, with the amounts undisclosed.