Advances in Fetal and Neonatal Diagnostics and Monitoring

Frost & Sullivan, June 2007

This Frost & Sullivan research service titled Advances in Fetal and Neonatal Diagnostics and Monitoring Technologies provides in-depth information about the various commercial products and technologies available in the market today and those on the verge of commercialization. In this research, Frost & Sullivan's expert analysts thoroughly examine the following technologies: ultrasound, magnetic resonance imaging (MRI), noninvasive fetal diagnostics and other emerging technologies.

The following technologies are covered in this research:

- Wireless/Remote Monitoring, Home-based Monitors
- Multiparametric Monitors – Brain, Cardiac monitoring
- Cell-free DNA Technologies
- Preimplantation Genetic Diagnosis
- Transrenal DNA Technologies

Obstetrics - A Promising Field for Telemetry and Wireless Technologies

Telemetry and wireless technologies have transformed the way prenatal and neonatal care is provided as well as the process of labor and delivery itself. Due to these technologies, electronic data transmission between remote clinics and tertiary prenatal care centers has become a reality, allowing doctors to have real-time discussions with patients in labor. New telemetry applications under development could revolutionize the field of obstetrics further by allowing obstetricians to diagnose patient conditions as well as provide continuous treatment guidance. "Obstetrics seems to be an ideal field for merging wireless technologies due to the defined and cyclical nature of pregnancy, which allows a standard data set to be recorded into a relational database for future study and prediction of outcomes," says the analyst of this research service. "By enabling real-time interaction between physicians and patients, telemedical and wireless monitoring systems may offer an excellent solution for obstetrics, as obstetricians can neither predict the onset of labor nor stay in continuous touch with the patient for monitoring the ongoing events."

Some noteworthy wireless technology trends include the development of minimally invasive and wireless handheld biosensors that can directly monitor the patient’s vital signs, eliminating the need for laboratory testing. There have been major advances in this regard recently in the application of complimentary processing and pattern analysis of biological signals for patient monitoring. Other emerging trends in patient monitoring are likely to be the integration of nanotechnology and state-of-the-art technologies such as bio micro-electromechanical systems (bio MEMS) microprocessors. These innovative micro- and nanosensing devices are likely to be monitoring aids in the future with applications in BP and temperature monitoring and pulse oximetry, among others.

Neonatal Monitoring and Prenatal Diagnostics become Safer and More Sophisticated due to Advances in Monitoring Technologies

Neonatal monitoring is seeing a distinct trend toward non-invasive techniques due to the small size and volume of the prematurely born infant. Advances in monitoring technologies in the recent past are allowing a greater number of physiological parameters to be monitored non-invasively such as blood gas, intracranial pressure, cerebral blood flow, and biochemicals. A multisensor intravascular monitoring device is a potential development in the future that could measure not only blood gases, but also various biochemical parameters. "The future of neonatal monitoring will move toward computerized physiological, biochemical, and patient management, and the incorporation of closed loop systems within the monitors to effectively treat infants at the instant of physiological or biochemical derangements," says the analyst.

Prenatal diagnostics has also seen numerous exciting developments with the emergence of safer and more effective techniques such as the cell-free fetal DNA diagnostic technique due to a better understanding of the genetic basis of various diseases. Currently, only a few clinical centers in the United States and Canada are using these techniques, but they pose a potential threat to present-day invasive gold standards such as amniocentesis and chorionic villus sampling (CVS). Interesting developments in fetal medicine are also taking place in the emerging field of preimplantation genetic diagnosis (PGD). PGD can be potentially used for prenatal genetic testing of cytogenetic and Mendelian disorders in embryos prior to being implanted in patients undergoing assisted reproductive technology (ART). However, PGD is still an investigational technique and its major drawback is that patients must undergo IVF in order to have PGD, even in the absence of fertility issues.

1. Executive Summary
-1. Scope and Methodology
--1. Scope and Segmentation
--2. Methodology
-2. Overview of Monitoring and Diagnostics
--1. Monitoring Industry
--2. Diagnostic Industry

2. Technology Adoption Factor Analysis
-1. Technology Primer
--1. Monitoring Techniques
--2. Future Directions--Fetal MRI vs Ultrasound
-2. Assessment of Monitoring Technology Trends
--1. Emerging Trends in Monitoring
--2. Wireless and Remote Monitoring--Benefits
--3. Challenges of Remote/Wireless Monitoring
-3. Assessment of Diagnostic Technology Trends
--1. Noninvasive Fetal Diagnostics--Emerging Trends
--2. Future Scope and Clinical Applications of Noninvasive Prenatal Diagnosis
-4. Strategic Analysis
--1. Drivers and Restraints for Monitoring Technologies
--2. Drivers and Restraints for Diagnostic Technologies
--3. Strategic Recommendations
-5. Mergers and Acquisitions/Collaborations and Funding Details
--1. Mergers and IP Acquisitions
--2. Collaborations
--3. Funding/Stakeholder Analysis

3. Technology Developments in Companies and Universities
-1. Corporate Developments--Monitoring
--1. Intrapartum Monitoring System Offers ST Waveform Analysis--Sweden
--2. Neonatal Brain Monitoring Device--Australia
--3. Home-Based Noninvasive Monitor for Counting Fetal Movements--USA
--4. An Advanced and Integrated System for Fetal/Maternal Monitoring--USA
--5. Fetoscopy Instrument Detects and Treats Twin to Twin Transfusion Syndrome--USA
--6. Fetal and Neonatal Monitoring and Information Management Systems--Germany
--7. Ultrasound-Based Labor Monitoring System--Israel
--8. Neonatal Brain Temperature Monitoring and Treatment System for HIE--USA
--9. Computerized Labor Monitoring System--Israel
--10. World's First Holter Fetal/Maternal Monitor--UK
--11. Other Noteworthy Innovations
-2. Corporate Developments--Diagnostics
--1. World's First Noninvasive Diagnostic Test for Down's Syndrome--USA
--2. Noninvasive Prenatal Diagnostic Method for Detecting Chromosomal Disorders--USA
3. IVD Test for Monitoring and Detection of Antepartum and Intrapartum GBS Infection--USA
--4. Other Noteworthy Technologies
-3. University Studies
--1. Novel Device Detects Fetal Brain Abnormalities in Utero--USA
--2. Real-Time Ultrasound Imaging in 3D Raises Hope for Early Diagnosis of Fetal Abnormalities--USA
--3. Cell-Free Prenatal Diagnostic Technology for the Analysis of Fetal Genetic Information--USA
--4. New Sensor Monitors Fetal Hypoxia--UK
--5. Combined Screening Technique for High-Risk Pregnancies--Canada
--6. 4D Fetal Heart Visualization Using Real-Time Volumetric Imaging--UK
--7. Noninvasive Preemptive Sepsis Monitor for Neonates--USA
--8. Neonatal Brain Scanner Based on Optical Tomography--UK
--9. Other Noteworthy Research

4. Patents and Key Industry Participants
-1. Patents
--1. Fetal/Neonatal Monitoring Methods
--2. Prenatal/Neonatal Diagnostic Testing Methods
-2. Key Contacts
--1. Company Contacts
--2. University Contacts

5. Decision Support Database
-1. Database Tables
--1. Birth Rate (2002-2012)
--2. Fertility Rate per Woman (2002-2012)
--3. Infant Mortality Rate per 1000 Live Births (2002-2012)
--4. Prevalence of Female Smokers (2002-2012)
--5. Number of Biotech Companies (2002-2012)
--6. Number of Abortions (2002-2012)

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