Major players in the fetal and neonatal monitoring devices and equipment market are GE Healthcare, Fisher & Paykel Healthcare Limited, Philips Healthcare, Atom Medical Corporation and Natus Medical Incorporated.
New York, May 04, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Fetal And Neonatal Monitoring Devices Global Market Report 2021: COVID 19 Impact and Recovery to 2030" - https://www.reportlinker.com/p06067932/?utm_source=GNW
The global fetal and neonatal monitoring devices market is expected to grow from $4.17 billion in 2020 to $4.8 billion in 2021 at a compound annual growth rate (CAGR) of 15.1%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $6.25 billion in 2025 at a CAGR of 6.8%.
The fetal and neonatal monitoring devices and equipment market consists of sales of fetal and neonatal monitoring devices and equipment and related services.Fetal and neonatal monitoring devices and equipment are used to assess fetal heart rate and contractions of the uterus during pregnancy and childbirth.
Ultrasound Dopplers and internal fetal monitors are widely-used fetal and neonatal monitors.
The fetal and neonatal monitoring device market is restricted by stringent regulatory policies governing this market.The fetal and neonatal device manufacturers need to pass through several tests and requirements laid down by different regulatory bodies.
Regulations like FDA’s Center for Devices and Radiological Health (CDRH), NMPA regulations, EU directives lay down some stringent regulations for this equipment.The changes related to customer data protection such as the European Union’s General Data Protection Regulation (GDPR), changes to equipment approval procedures and other regulatory changes lead to increased healthcare costs.
For instance, according to a report by Ernst and Young, Fortune 500 companies are spending $7.8 billion to comply with GDPR regulations. The GDPR regulation is an EU law on data protection and privacy of individuals residing the European Union and the European Economic Area (EEA). Furthermore, the FDA is requesting more clinical data to support claims resulting in increased processing times of 510(k)s by over 55% over the last decade, thus delay the operating cycle of manufacturers in this market.
In June 2018, Hong Kong’s Department of Health, a regulatory body for fetal and neonatal monitoring devices of Hong Kong, sent a medical device safety alert to Guangzhou Sunray Medical Apparatus Co., Ltd, a medical device manufacturer, concerning its maternal and fetal monitor. The safety alert was sent as the Guangzhou Sunray maternal and fetal monitor was delivering inaccurate ultrasound-derived fetal heart rate recordings due to software-related issue. These devices impacted patients’ health with delayed intervention resulting in severe injury or death to the fetus. To reduce incidences associated with these devices MRHA sent a medical device safety alert to correct the device.
Similarly, in March 2019, Philips Medical Systems, a medical device manufacturer, was sent a medical device safety alert on Philips Fetal Spiral Electrode (FSE) to define its usage instructions due to an increase cases of tip breakage of the spiral electrode. The safety alert was sent as it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
Fetal and neonatal monitoring device manufacturers are increasingly innovating and integrating technologies such as wireless technology with patient monitoring devices to efficiently diagnose and monitor fetus and new-borns.Wireless sensor technology such as biosensor monitoring devices, wireless fetal heart rate monitoring devices are multi sensor systems implanted or embedded into the skin, consisting of a sensor that transmits data for real time monitoring of patient’s medical condition.
For instance, the National Institute of Neurological Disorders and Stroke developed SARA, a scanning device that can detect fetal brain activity with the help of flashes of light transmitted through the mother’s abdomen.Philips developed a new cordless fetal monitoring device that helps in ensuring the safety of the mother as well as the child without any inconvenience and risk.
These technological innovations eliminate poor reception of observation and help caregivers in monitoring more efficiently.
The increasing prevalence of preterm births and low body weight of infants acts as factor driving the fetal and neonatal monitoring devices market growth.Preterm birth refers to premature birth of a child before 37 weeks gestation period, which leads to poor health and growth, mental retardation, visual and hearing impairments, cerebral palsy and others.
According to World Health Organization (WHO), around 1 million babies die each year and preterm birth was found to be one of the top reasons for the deaths.According to the report by WHO, nearly 15 million babies are born preterm every year and this number is expected to have a continuous rise in the near future.
The increasing prevalence and need to reduce the infant mortality rates with improving healthcare conditions, drives the fetal and neonatal monitoring devices market. For instance, according centers of Disease Control and Prevention (CDC), in 2019 the preterm birth rates in the African-American women was 14.4%. Furthermore, the low birth weight rate increased to 8.16% in 2016 from 8.07% in 2015.
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