Xiya Fetal Monitor Receives Class II Medical Device Certification; Xinchen Health Plans to Build Maternal and Child Safety Industrial Chain

Recently, the National Health Commission pointed out in the "Report on the Development of Maternal and Child Health Services in China (2019)" that in 2018, the national maternal mortality rate was 18.3 per 100,000 live births, and the infant mortality rate was 6.1‰. With the relaxation of the two-child policy, advanced maternal age has become a common social phenomenon, with the average age of pregnant women in China now approaching 30 years.

During pregnancy, fetal safety is the most critical concern for expectant mothers and must not be overlooked. Even minor negligence can compromise the health of the newborn or even pose a life-threatening risk to the fetus. “When I was working as a pediatrician, I observed that many cases of intellectual disability in children were directly linked to intrauterine hypoxia during the perinatal period and inadequate maternal-fetal monitoring,” said Wang Xin, Chairman of Xinchen Health.

How can this issue be prevented? Real-time monitoring of the fetal heart rate becomes particularly crucial. Currently, pregnant women must visit large hospitals to receive fetal heart monitoring.

“Can fetal heart rate monitoring be performed at home anytime, anywhere? Can technical services with efficacy equivalent to that of major hospitals be enjoyed at home?” After proposing this idea, Wang Xin led his team to Europe to seek leading technologies capable of replacing Doppler-based systems, and through secondary development, launched the first auscultation-based fetal monitor, “Xiya.”

Wang Xin told VCBeat (WeChat ID: vcbeat) that Xiya obtained the Class II medical device certification from the National Medical Products Administration (NMPA) earlier this year and is currently accelerating production to meet market demand. The launch of Xiya signifies a shift in fetal heart rate monitoring from traditional hospital settings to home-based care, ushering in the era of Fetal Heart Rate Monitoring 2.0.

“Investing and starting a business is not just about maximizing profits; it also means following your heart, serving society, and benefiting the public,” Wang Xin said emphatically.

In the early 1990s, Wang Xin left his position as a pediatrician to enter the pharmaceutical market and single-handedly founded Xincheng Group.

(Wang Xin, Chairman of Xinchen Health)

Xinchen Group, established in 1996, is a high-tech joint-stock conglomerate integrating the research and development, manufacturing, promotion, and sales of medical products. It owns multiple subsidiaries, including Jiangsu Xinchen Health Technology Co., Ltd., Jiangsu Qin’anfang Co., Ltd., and Jiangsu Yuanjing Technology Co., Ltd. The Group’s business scope covers the R&D, production, and sales of medical and health products, such as pharmaceuticals, medical devices, nutritional supplements, and health-oriented apparel.

According to data released by Analysys, the market size of China’s maternal and infant industry reached RMB 2.77 trillion in 2018 and was projected to exceed RMB 3 trillion in 2020. Reflecting on his experience as a pediatrician and considering the growing demand in the maternal and infant market, Wang Xin identified significant growth potential in China’s smart maternal and infant monitoring device sector.

“In 2014, I redirected my primary focus back to my core profession in healthcare and established the development direction for intelligent maternal and infant products,” said Wang Xin.

"Silent until the moment it speaks, then astonishing the world." Wang Xin, who focuses on intelligent maternal and infant products, has become the focal point of the industry with his debut.

“When I worked as a pediatrician, my greatest concern was maternal and infant safety. Once expectant mothers leave the hospital, who monitors the fetus’s well-being? The market needs a smart product that truly offers convenience to mothers and safeguards fetal health. This was the driving force behind my development of the Xiya Fetal Monitor,” said Wang Xin.

From 2014 to 2016, Wang Xin led his elite team in preparing for product research and development, during which they identified a series of technical challenges associated with fetal heart rate monitoring.

“Ultrasound Doppler fetal heart rate monitors used in hospitals are bulky, expensive, and limited to clinical settings. How can we develop an alternative that meets the needs of home use? This requires significant technological breakthroughs,” said Wang Xin. Looking globally, no product capable of replacing Doppler technology had been commercialized at the time, representing both a market pain point and an opportunity.

To this end, he led his core technical team on extensive trips to European countries such as Denmark, Hungary, and Germany in search of companies with leading-edge technologies. In 2015, he identified an advanced fetal heart rate monitoring product in Israel; however, negotiations stalled due to the supplier’s exorbitant asking price.

By the end of 2016, Wang Xin had identified an auscultation-based technology in Germany capable of delivering all the functionalities of Doppler ultrasound. “I contacted the other party a few days before Christmas and immediately flew to Budapest,” Wang recalled. Following a series of negotiations, both sides signed a technology transfer and cooperation agreement in early 2017. In July of the same year, Wang established Xinchen Health, a subsidiary of the Xinchen Group.

“We acquired exclusive rights to the core technology of PentaVox Group’s fetal heart rate monitoring systems, to the extent that the European Union is now urging us to establish a joint venture in Europe,” said Wang Xin.

After acquiring the core technology, Wang Xin led the technical team to accelerate the research and development of fetal heart monitoring products. Following more than a year of secondary R&D, Xiya passed national technical testing in June 2018 and, in January 2019, became the world’s first non-ultrasound Doppler-based fetal monitor to obtain medical device certification.

(Xiya Auscultation Fetal Monitor)

The Unique Feature of Xiya's Auscultation-Style Fetal Monitor Lies in Achieving Ultrasound Doppler Functionality Through Physical Technology. Product Features Include: Medical-Grade Fetal Monitoring Probe, European Fetal Monitoring Technology, Fetal Heart Rate Positioning System, Nine-Dimensional Medical-Grade Fetal Heart Monitoring Data, Online Doctor Interpretation of Monitoring Reports, and Alert Notifications for Abnormal Data.

Furthermore, Xiya does not require coupling gel, offering convenient wearability anytime and anywhere. It does not emit ultrasonic energy waves, poses no radiation hazards, and has no adverse safety effects on the fetus, allowing for safe use without the need for professional medical supervision.

Its fetal monitoring technology is derived from Pentavox Group’s patented auscultatory-based fetal heart sound extraction technology. By avoiding the emission of ultrasonic energy waves and employing neurobiological algorithms to filter out noise, it accurately extracts fetal heart sounds. This technology has been used in clinical practice in Europe for over two decades and has gained widespread recognition among European medical institutions.

Beyond the technical aspects, Xiya boasts a professional medical team and leverages artificial intelligence, big data, and medical knowledge graph processing technologies to provide rapid report analysis for each fetal heart rate monitoring session. Additionally, by establishing pregnancy health records for expectant mothers and integrating fetal heart rate monitoring data, it offers necessary alerts and reminders.

Xiya cannot replace doctors in making clinical decisions, but it can provide timely warnings for conditions such as fetal hypoxia and preterm birth, prompting pregnant women to seek medical attention promptly to prevent more severe complications.

“It took us nearly three years to go from acquiring the prototype and technology, through product upgrades and development, to achieving mass production this month. The entire process of implementing, integrating, optimizing, and upgrading the technology was truly no easy feat,” remarked Wang Xin.

Fortunately, Xiya has received positive industry feedback. Wang Xin revealed that Xincheng Health is currently working closely with the Jiangsu Provincial Health Commission to jointly build the Jiangsu Maternal and Infant Safety Monitoring Platform. The Xiya fetal monitor will leverage this platform to provide comprehensive services to every expectant mother.

“Our product won the bid for Nangqian County People’s Hospital in Yushu, Qinghai Province, shortly after its launch at the beginning of the year. Given the relatively underdeveloped medical services in the local area, we hope that Xiya’s intelligent technologies can provide some effective support,” said Wang Xin.

Currently, Xiya has been deployed in multiple hospitals, including the Jiangsu Provincial Hospital of Maternity and Child Health Care. “Xiya offers significant advantages, and I am highly confident in its performance. In terms of safety, Xiya employs an absolutely safe auscultation-based principle, eliminating any potential harm to the fetus. Regarding usability, while Doppler devices require operation by medical personnel, Xiya can be conveniently operated by pregnant women themselves, thereby reducing labor costs for hospitals,” said Wang Xin.

He stated that Xiya aims to serve over one million expectant mothers per day within the next two years, and, if feasible, plans to eventually provide its services free of charge to every expectant mother.

“As a physician, I need to prescribe medications that offer genuine clinical value. Safeguarding the health of mothers and infants—both for families and society—is the mission behind my product development,” said Wang Xin.

In addition to the Xiya product, Xinchen Health will next comprehensively expand its offerings around the “prenatal and postpartum” phases for expectant mothers, building a comprehensive maternal and infant safety industry chain.

“Through these smart devices and the collection of health data, we can better safeguard the health of mothers and infants,” said Wang Xin. Currently, Xinchen Health is developing a smart device for postpartum rehabilitation. Featuring globally leading technology, this device will help many new mothers overcome physiological challenges encountered during postpartum recovery.

“Previously, new mothers had to spend 50,000 to 100,000 yuan on postpartum recovery at confinement centers, while professional rehabilitation equipment in hospitals cost as much as 700,000 to 800,000 yuan. Our smart product will significantly reduce these recovery costs,” said Wang Xin.

He stated that the product is expected to finalize its design and submit for registration in the second half of this year.

“We will also submit a proposal for an intelligent monitoring system in the next phase. In the future, we expect to launch products targeting individuals with infertility, as well as establish high-end smart maternal and child hospitals. Our R&D efforts in smart healthcare products are accelerating, and the maternal and infant safety industry chain holds promising prospects,” said Wang Xin.