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Fetal Monitoring, Diagnostics and Predictive Tests

Fetal Monitoring, Diagnostics and Predictive Tests

The global market for fetal monitoring, prenatal diagnostics, predictive tests and neonatal monitoring was valued at roughly $8.6 billion in 2013 and about $9.0 billion in 2014. This market is expected to reach about $10.9 billion by 2019, with a compound annual growth rate (CAGR) of 4.0% from 2014 to 2019.

This report provides:

An overview of the global markets for fetal monitoring, diagnostics, and predictive tests.

Analyses of global market trends, with data from 2013 and 2014, and projections of compound annual growth rates (CAGRs) through 2019.

Information on the strengths and weaknesses of each category of fetal monitoring and diagnosis in addition to new technologies and developments, manufacturer and supplier competition, and the changing environment of the market due to the increasing awareness of expectant mothers.

Discussion covering acquisitions, mergers, and alliances by companies and global organizations.

Comprehensive company profiles of major players in the industry.


SCOPE OF THE STUDY

This study is mainly focused on fetal monitoring and related markets. Therefore, it does not focus on neonatal monitoring. The study is focused on fetal diseases, fetal monitoring products, diagnostic and predictive tests. The study has listed almost all the participating companies in the fetal monitoring sector and their products relevant to this field.

CHAPTER 1 INTRODUCTION
STUDY OBJECTIVES
INTENDED AUDIENCE
SCOPE OF THE STUDY
METHODOLOGY
INFORMATION SOURCES
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 EXECUTIVE SUMMARY
SUMMARY TABLE GLOBAL MARKET FOR FETAL MONITORING, PRENATAL DIAGNOSTICS, PREDICTIVE TESTS AND NEONATAL MONITORING, THROUGH 2019 ($ MILLIONS)
SUMMARY FIGURE GLOBAL MARKET FOR FETAL MONITORING, PRENATAL DIAGNOSTICS, PTREDICTIVE TESTS AND NEONATAL MONITORING, 2013-2019 ($ MILLIONS)
CHAPTER 3 INDICATIONS ADDRESSED BY FETAL MONITORING AND RELATED DIAGNOSTICS: AN OVERVIEW
HIGH-RISK PREGNANCIES
FACTORS FOR HIGH-RISK PREGNANCIES
Advanced Maternal Age (AMA)
Medical Conditions Existing Before Pregnancy
TABLE 1 MATERNAL/FETAL CONCERNS DUE TO CERTAIN PRE-EXISTING
MATERNAL CONDITIONS
Medical Conditions Occurring During Pregnancy
Preeclampsia (Toxemia)
Gestational Diabetes
Pregnancy-Related Issues
Premature Labor
Multiple Births
Placenta Previa
Fetal Problems
FETAL GROWTH RESTRICTIONS
FIGURE 1 DISTRIBUTION OF SMALL FETUSES DUE TO FETAL GROWTH RESTRICTIONS (%)
PRETERM BIRTHS
TABLE 2 WEIGHT, LENGTH, AND HEAD CIRCUMFERENCE BY GESTATIONAL AGE (LB/INCHES)
Global Epidemiology of Preterm Births
FIGURE 2 RISK FACTORS FOR NEONATAL AND POSTNEONATAL DEATHS (%)
Classification of Preterm Birth
TABLE 3 CLASSIFICATION OF PRETERM, TERM AND POST-TERM BIRTHS
Preterm Birth Complications
TABLE 4 LONG-TERM IMPACT OF PRETERM BIRTHS ON SURVIVORS
Causes of Preterm Birth
TABLE 5 TYPES OF PRETERM BIRTHS AND RISK FACTORS
Global Rates of Preterm Births
TABLE 6 THE TOP 20 COUNTRIES WITH MAXIMUM PRETERM BIRTH RATES
FIGURE 3 AVERAGE RATES OF PRETERM BIRTH RATES BY REGION PER YEAR (%)
OLIGOHYDRAMNIOS
ABNORMAL PLACENTAL BLOOD FLOW
MECONIUM STAINED LIQUOR
BEECH PRESENTATION
CHAPTER 4 FETAL MONITORING TECHNOLOGIES: AN OVERVIEW
A BRIEF INTRODUCTION TO FETAL MONITORING
FETAL HEART RATE (FHR)
DOPPLER ULTRASOUND
Limitations of Doppler Ultrasound
FETAL ELECTROCARDIOGRAM
FETAL MOVEMENT
Hand-held Patient Event Marker
Automatic Fetal Movement Detector (FMD or Actogram)
MATERNAL CONTRACTION
External Tocodynamometer
Intrauterine Pressure Monitoring
PRINT-OUT
Print-Out on Thermal Paper
TRACE INTERPRETATION
SOFTWARE ANALYSIS
TECHNOLOGICAL ADVANCEMENTS IN FETAL MONITORING
CHANGES IN BIRTH TECHNOLOGY
THE FUTURE OF FETAL MONITORING
New Fetal Heart Monitoring Technologies
STAN Monitor
The Monica AN24 Monitor
MindChild MERIDIAN Monitor
Newer Nonvoltage Fetal Heart Monitoring Technologies
Newer Uterine Contraction Monitoring Technologies
VENDORS AND PRODUCTS FOR FETAL MONITORING
FETOSCOPE
TABLE 7 SELECTED FETOSCOPE PRODUCTS AND VENDORS
FETAL HEART DOPPLER
Types of Fetal Heart Doppler
Difference between 2 MHz Probes and 3 MHz Probes in Fetal Doppler
TABLE 8 MARKET LEADING FETAL DOPPLERS AND VENDORS
FETAL MONITORS
External Fetal Monitors
TABLE 9 MARKET-LEADING EXTERNAL FETAL MONITOR VENDORS AND THEIR PRODUCTS
Internal Fetal Monitors
Fetal Scalp Electrodes
Indications
Contraindications
TABLE 10 FETAL SCALP ELECTRODES: PRODUCTS AND VENDORS
TELEMETRY
TABLE 11 CENTRAL MONITORING STATIONS: PRODUCTS AND VENDORS
FETAL ECG (FECG)
Meridian Monitor
Monica AN24
FETAL PULSE OXIMETER
FETAL ULTRASOUND
Types of Fetal Ultrasound Exams
Safety of Diagnostic Ultrasound in Fetal Scanning
Adverse Effects
Thermal Effects
Cavitation
Other Mechanical Effects
The Effect of Ultrasound on Fetuses
TABLE 12 PRODUCTS AND VENDORS OF GYNECOLOGICAL AND OBSTETRIC ULTRASOUND SYSTEMS
RECENTLY APPROVED ULTRASOUND SYSTEMS
TABLE 13 PREMARKET APPROVALS FOR ULTRASOUND SYSTEMS, 2012 TO JULY 2014
FETAL MAGNETIC RESONANCE IMAGING (MRI)
TABLE 14 LEADING VENDORS OF MRI SYSTEMS AND PRODUCTS
NEONATAL MONITORING
Monitoring in the NICU
ECG Monitoring
Radiant Warmers
Incubator
Cardiorespiratory Monitor
Phototherapy Lamps
CHAPTER 5 PRENATAL DIAGNOSIS AND FETAL THERAPY
ESSENTIALS OF PRENATAL DIAGNOSIS AND FETAL THERAPY
PRENATAL SCREENING TESTS
TABLE 15 PRENATAL SCREENING TESTS BY PREGNANCY STAGES
Pregnancy and Prenatal Screening Tests
TABLE 16 SCREENING TESTS DURING PREGNANCY
First Trimester Beta Human Chorionic Gonadotropin (Beta–hCG)
Screening Test
TABLE 17 HCG LEVELS IN WEEKS FROM LAST NORMAL MENSTURAL
PERIOD (LMP) (mLU/ml)
Beta–hCG Kits and Vendors
TABLE 18 SELECTED BETA-HCG KITS AND VENDORS
First Trimester Pregnancy-Associated Plasma Protein-A (PAPP-A)
Screening Test
TABLE 19 SELECTED PAPP-A TEST KITS AND VENDORS
Second Trimester Maternal Serum Alpha-fetoprotein (MSAFP) Screening
Test
TABLE 20 SELECTED MSAFP TEST KITS AND VENDORS
Second Trimester Serum beta-hCG Screening Test
Second Trimester Unconjugated Estriol (uE3) Screening Test
TABLE 21 SELECTED UE3 TEST KITS
Second Trimester Inhibin-A Screening Test
TABLE 22 SELECTED INHIBIN-A TEST KITS
Second Trimester Maternal Hexosaminidase Screening Test
TABLE 23 SELECTED MATERNAL HEXOSAMINIDASE TEST KITS
Second Trimester Screening of Cell-Free Fetal DNA (cffDNA)
Second Trimester Triple-Screen Test
TABLE 24 SECOND TRIMESTER MATERNAL SERUM SCREENING
ANALYTE PATTERNS
TABLE 25 SOME GENETIC DISORDERS THAT CAN BE DETECTED
BEFORE BIRTH
PRENATAL DIAGNOSTIC TESTS
TABLE 26 PRENATAL DIAGNOSTIC TESTS BY PREGNANCY STAGE
First Trimester Fetal Ultrasonography Diagnostic Test
Threatened Abortion
First Trimester Induced Abortion
First Trimester Ultrasound Guidance for Invasive Diagnostic
Procedures
Cervical Cerclage
Multiple Gestations
Ectopic Pregnancy
Molar Pregnancy
Pelvic Mass
First Trimester Chorionic Villus Sampling (CVS) Diagnostic Test
First Trimester Early amniocentesis Diagnostic Test
First Trimester Preimplantation biopsy Diagnostic Test
Types of PGS
First Trimester Coelocentesis Diagnostic Test
Second Trimester Amniocentesis
Second Trimester Percutaneous Umbilical Cord Blood Sampling (PUBS)
Diagnostic Test or Cordocentesis
Second Trimester Fetal Muscle and Liver Biopsy
Third Trimester Amniocentesis
Third Trimester Nonstress Test (NST)
Third Trimester Biophysical Profile Test (BPP)
TABLE 27 THE FIVE BIOPHYSICAL ATTRIBUTES STUDIED DURING BPP
Third Trimester Contraction Stress Test (CST)
Third Trimester Doppler Study
RADIOLOGICAL STUDIES IN PRENATAL DIAGNOSIS
TABLE 28 RADIOLOGICAL STUDIES IN PRENATAL DIAGNOSIS
Ultrasonography in Fetal Diagnosis
TABLE 29 APPLICATIONS OF ULTRASONOGRAPHY IN PREGNANCY
Magnetic Resonance Imaging in Fetal Diagnosis
TABLE 30 MRI INDICATIONS FOR FETAL DIAGNOSIS WHEN THERE ARE ULTRASOUND-RELATED PROBLEMS
Fetal Magnetocardiography (FMCG)
FETAL MANAGEMENT
RECENT TRENDS PRENATAL DIAGNOSTIC TESTS
Noninvasive Prenatal Tests
NIPT Patent Landscape
TABLE 31 U.S. PATENTS AND PATENT APPLICATIONS FOR
NONINVASIVE PRENATAL TESTS AS OF JULY 2013
FIGURE 4 GENETIC DISORDERS DETECTABLE BY PRENATAL TEST METHODS (%)
U.S. Patents Issued for Noninvasive Prenatal Testing, 2010 through
2012
TABLE 32 RECENT U.S. PATENTS ISSUED FOR NONINVASIVE
PRENATAL TESTING
U.S. Cost of cfDNA Prenatal Testing
TABLE 33 U.S. COSTS OF RECENTLY LAUNCHED PRENATAL GENETIC TESTS ($)
Next-Generation Sequencing (NGS)
NGS in Diagnosis
Currently Available NGS Platforms for NIPT
TABLE 34 CURRENTLY AVAILABLE NGS PLATFORMS FOR NIPT
Market Leaders in NGS Platforms for Fetal Diagnosis
TABLE 35 COMMERCIALLY AVAILABLE NGS PLATFORMS FOR CFDNA
TESTS
Commercially Available for NIPT for Trisomies
TABLE 36 COSTS OF COMMERCIAL TESTS AVAILABLE FOR NIPT OF TRISOMIES ($)
CHAPTER 6 PREDICTIVE GENETIC TESTING
PREDICTIVE TESTS RELATED TO PREGNANCY
RISK FACTORS FOR PREGNANCY-RELATED PREDICTIVE TESTS
TYPES OF PREGNANCY-RELATED PREDICTIVE TESTS
Preconception Genetic Testing
TABLE 37 GENETIC DISORDERS DETECTED BY CARRIER PREDICTIVE
TEST
EFFECTS OF CHROMOSOMAL DEFECTS ON FETUSES
Trisomy 13: Patau Syndrome
Trisomy 18: Edwards Syndrome
Tay-Sachs disease
Trisomy 21: Down Syndrome
Klinefelter Syndrome (47, XXY Karyotype)
Achondroplasia
Phenylketonuria (PKU)
Cystic Fibrosis
Fragile X Syndrome (FXS)
Turner Syndrome
TOTAL NUMBER OF PREDICTABLE CARRIER GENETIC DISEASES
TABLE 38 TOTAL NUMBER OF PREDICTABLE CARRIER GENETIC DISEASES
Chance of Being a Carrier of Genetic Disease
TABLE 39 CHANCE OF BEING A CARRIER OF GENETIC DISEASE
SPECIFIC GENES OF FETAL DISORDERS
TABLE 40 LIST OF PRENATAL GENETIC DISORDERS, GENES AND LOCATIONS
CAUSES OF BIRTH DEFECTS
FIGURE 5 CAUSES OF FETAL ABNORMALITIES (%)
COMMERCIALLY AVAILABLE GENETIC TESTS FOR CARRIER SCREENING
TABLE 41 COMMERCIALLY AVAILABLE GENETIC TESTS FOR CARRIER SCREENING
Preimplantation Genetic Testing
Preimplantation Genetic Diagnosis (PGD/PGS) Technologies
TABLE 42 COMPARISON OF AVAILABLE PGD/PGS TECHNOLOGIES
Fluorescent In-Situ Hybridization (FISH)
DNA Microarray Technology
Array Comparative Genome Hybridization (aCGH)
Single Nucleotide Polymorphism Microarray (SNP Microarray)
Oligonucleotide Genome Sequencing (OGS)
Express Genome Screening (EGS)
FUTURE OF PGD
PGD Testing Products in the Market
TABLE 43 COMPANIES AND PRODUCTS FOR PGD TESTING
Preimplantation Genetic Diagnosis (PGD) and In Vitro Fertilization (IVF)
Cost
TABLE 44 AVERAGE COST FOR PGD TESTING IN THE U.S. ($)
CHAPTER 7 MARKET ANALYSIS
MARKET OVERVIEW
TABLE 45 GLOBAL MARKET FOR FETAL MONITORING, PRENATAL DIAGNOSTICS, AND NEONATAL MONITORING BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 6 GLOBAL MARKET FOR FETAL MONITORING, PRENATAL DIAGNOSTICS, PREDICTIVE TESTS AND NEONATAL MONITORING BY REGION, THROUGH 2019 ($ MILLIONS)
FETAL MONITORING: MARKET OVERVIEW
TABLE 46 GLOBAL MARKET FOR ELECTRONIC FETAL MONITORS (EFM) BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 7 GLOBAL MARKET FOR ELECTRONIC FETAL MONITORS BY REGION, 2013-2019 ($ MILLIONS)
Market Leaders in Electronic Fetal Monitoring
TABLE 47 GLOBAL MARKET SHARES: ELECTRONIC FETAL MONITOR MANUFATURERS, 2013 (%)
FIGURE 8 GLOBAL MARKET SHARES: ELECTRONIC FETAL MONITOR MANUFACTURERS, 2013 (%)
Global Market for Fetal Dopplers
TABLE 48 GLOBAL MARKET FOR FETAL DOPPLERS BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 9 GLOBAL MARKET FOR FETAL DOPPLERS BY REGION, 2013-2019 ($ MILLIONS)
Market Leaders in Fetal Dopplers
TABLE 49 GLOBAL MARKET SHARES: FETAL DOPPLER MANUFACTURERS, 2013 (%)
FIGURE 10 GLOBAL MARKET SHARES: FETAL DOPPLER MANUFACTURERS, 2013 (%)
Global Market for Others Category of Fetal Monitors
TABLE 50 GLOBAL MARKET FOR OTHERS CATEGORY OF FETAL MONITORS BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 11 GLOBAL MARKET FOR OTHERS CATEGORY OF FETAL MONITORS BY REGION, THROUGH 2019 ($ MILLIONS)
Market Leaders in Others Category of Fetal Monitoring Products
TABLE 51 GLOBAL MARKET SHARES: OTHER FETAL MONITOR MANUFACTURERS, 2013 (%)
FIGURE 12 GLOBAL MARKET SHARES: OTHER FETAL MONITOR MANUFACTURERS, 2013 (%)
PRENATAL DIAGNOSTICS: MARKET OVERVIEW
Global Market for Fetal Ultrasound
TABLE 52 GLOBAL MARKET FOR PRENATAL MONITORING BY ULTRASOUND AND ULTRASONOGRAPHY BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 13 GLOBAL MARKET FOR PRENATAL MONITORING BY ULTRASOUND AND ULTRASONOGRAPHY BY REGION, 2013-2019 ($ MILLIONS)
Market Leaders in Fetal Ultrasound Systems
TABLE 53 GLOBAL MARKET SHARES: FETAL ULTRASOUND MANUFACTURERS, 2013 (%)
FIGURE 14 GLOBAL MARKET SHARES: FETAL ULTRASOUND MANUFACTURERS, 2013 (%)
Global Market for Fetal MRI
TABLE 54 GLOBAL MARKET FOR PRENATAL MONITORING BY MAGNETIC RESONANCE IMAGING, BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 15 GLOBAL MARKET FOR PRENATAL MONITORING BY MAGNETIC RESONANCE IMAGING, BY REGION, 2013-2019 ($ MILLIONS)
Market Leaders in Fetal MRI
TABLE 55 GLOBAL MARKET SHARES: FETAL MRI MANUFACTURERS, 2013 (%)
FIGURE 16 GLOBAL MARKET SHARES: FETAL MRI MANUFACTURERS, 2013 (%)
Global Market for Amniocentesis and Chorionic Villus Sampling (CVS)
TABLE 56 GLOBAL MARKET FOR PRENATAL MONITORING BY AMNIOCENTESIS AND CHORIONIC VILLUS SAMPLING BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 17 GLOBAL MARKET FOR PRENATAL MONITORING BY AMNIOCENTESIS AND CHORIONIC VILLUS SAMPLING BY REGION, 2013-2019 ($ MILLIONS)
Global Market for Noninvasive cfDNA Tests
Reimbursement Landscape for NIPT
TABLE 57 GLOBAL MARKET FOR NONINVASIVE CFDNA PRENATAL TESTING, THROUGH 2019 ($ MILLIONS)
FIGURE 18 GLOBAL MARKET FOR NONINVASIVE CFDNA PRENATAL TESTING, THROUGH 2019 ($ MILLIONS)
Others Category of Prenatal Diagnostics (Maternal Serum Screening)
TABLE 58 GLOBAL MARKET FOR PRENATAL MONITORING BY SCREENING AND OTHER TESTS, BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 19 GLOBAL MARKET FOR PRENATAL MONITORING BY SCREENING AND OTHER TESTS, BY REGION, 2013-2019 ($ MILLIONS)
Preimplantation Genetic Diagnosis and Screening (PGD/PGS)
TABLE 59 GLOBAL PREIMPLANTATION GENETIC DIAGNOSIS AND SCREENING (PGD/PGS) MARKET, THROUGH 2019 ($ MILLIONS)
FIGURE 20 GLOBAL PREIMPLANTATION GENETIC DIAGNOSIS AND SCREENING (PGD/PGS) MARKET, 2013-2019 ($ MILLIONS)
NEONATAL MONITORING PRODUCTS MARKET
TABLE 60 GLOBAL MARKET FOR NEONATAL MONITORING PRODUCTS, THROUGH 2019 ($ MILLIONS)
FIGURE 21 GLOBAL MARKET FOR NEONATAL MONITORING PRODUCTS, 2013-2019 ($ MILLIONS)
CHAPTER 8 FETAL MONITORING INDUSTRY PARTICIPANTS
TABLE 61 MARKET PARTICIPANTS
CHAPTER 9 LATEST INNOVATIONS IN FETAL MONITORING SECTOR: 2014
NEED FOR INNOVATIONS
SMART FABRIC BELLY BAND
LABORVIEW SENSOR SYSTEM
BRLLABEAT INTERACTIVE MONITORING DEVICE
BENCHTOP SEMICONDUCTOR SEQUENCING PROCEDURE
SMART SOCK MONITOR
CHAPTER 10 COMPANY PROFILES
ABBOTT LABORATORIES
BRIEF HISTORY
PRODUCT
ARCHITECT AFP Assay
REVENUE HISTORY
TABLE 62 ABBOTT'S REVENUES, 2011-2013 ($ MILLIONS)
ABBOTT MOLECULAR INC.
BRIEF HISTORY
PRODUCTS
AneuVysion
Cystic Fibrosis Genotyping Assay
ABCAM PLC
BRIEF HISTORY
PRODUCT
hCG Human ELISA Kit
ADALTIS S.R.L.
BRIEF HISTORY
PRODUCT
CLIAgen Free Beta-hCG Kit
AMBISEA TECHNOLOGY CORP. LTD.
BRIEF HISTORY
PRODUCTS
AMBULANC (SHENZHEN) TECH. CO. LTD.
BRIEF HISTORY
PRODUCTS
Fetal Monitor
Fetal Doppler (A8200S2P)
Fetal Doppler (A8200S2)
Fetal Doppler (A8200S1P)
Fetal Doppler (A8200S1)
Fetal Doppler (A8200S5T)
ANALOGIC CORP.
BRIEF HISTORY
Ultrasound Systems
FlexFocus Family of Ultrasound Systems
Sonix Family of Ultrasound Systems
REVENUE HISTORY
TABLE 63 ANALOGIC'S REVENUE HISTORY, 2009-2013 ($ MILLIONS)
TABLE 64 ANALOGIC'S REVENUE HISTORY BY BUSINESS SEGMENTS, 2012 AND 2013 ($ THOUSANDS)
ANSH LABS
BRIEF HISTORY
PRODUCTS
picoPAPP-A ELISA
Inhibin A ELISA
ARIOSA DIAGNOSTICS INC.
BRIEF HISTORY
PRODUCT
Harmony Test
ATOM MEDICAL CORP.
BRIEF HISTORY
PRODUCTS
Atom Fetal Doppler
Infant Incubator and Infant Warmers
Examination Light
Therapeutic Equipment
Respiratory Equipment
Infusion Device
BECKMAN COULTER INC.
BRIEF HISTORY
PRODUCTS
Access Total Beta-hCG
Access Inhibin A Assay
BERRY GENOMICS
BRIEF HISTORY
PRODUCT
BambniTest
BIONET AMERICA INC.
BRIEF HISTORY
PRODUCTS
FC700 Single Fetus Monitor
TwinView FC 1400
BISTOS AMERICA INC.
BRIEF HISTORY
PRODUCTS
BT350 Fetal Monitor
BT200 Hi Bebe Fetal Doppler Series
BT-500
BRAEL
BRIEF HISTORY
PRODUCTS
BFM-10
BFM-10 TWIN
FD 10D BabyPlus
UDT-20SD
UDT-300D
UDT-300SD
UDT-300 with Record
CELLSCAPE CORP.
BRIEF HISTORY
COMBIMATRIX CORP.
BRIEF HISTORY
PRODUCTS
CombiSNP Array for Prenatal Analysis
REVENUE HISTORY
TABLE 65 COMBIMATRIX'S REVENUE, THROUGH 2013 ($ THOUSANDS)
CONTEC MEDICAL SYSTEMS CO. LTD.
BRIEF HISTORY
PRODUCTS
CMS800G
Baby Sound C
CMS800H Fetal Monitor
CMS600B2 B-Ultrasound Diagnostic System
CMS600P B-Ultrasound Diagnostic System
Sonoline C2 Pocket Fetal Doppler
Baby Sound A
Baby Sound B Pocket Fetal Doppler
CMS600P2 B-Ultrasound Diagnostic System
Sonoline H Pocket Fetal Doppler
CMS600B3 B-Ultrasound Diagnostic System
Sonoline A Pocket Fetal Doppler
Sonoline B Pocket Fetal Doppler
Sonoline C
Sonotrax A Pocket Fetal Doppler
Sonotrax B
COOPERSURGICAL INC.
BRIEF HISTORY
PRODUCTS
ClearTone
MedaSonics First Beat
MedaSonics TRIA II Hand–held Doppler
Fetal Monitor F9
COUNSYL INC.
BRIEF HISTORY
PRODUCTS
Family Prep Screen
Inherited Cancer Screen
COVIDIEN PLC
BRIEF HISTORY
PRODUCTS
Puritan Bennet 980 Ventilator
Puritan Bennett 840 Ventilator
Nellcor Bedside Respiratory Patient Monitoring System
Nellcor Portable SpO2 Patient Monitoring System
Nellcor Bedside SpO2 Patient Monitoring System
Nellcor N-560 Pulse Oximetry Monitor
Nellcor N-600x Pulse Oximeter
Nellcor N-65 Hand-Held Pulse Oximeter
Nellcor N-85 Pulse Oximetry Monitor
REVENUE HISTORY
TABLE 66 COVIDIEN'S REVENUES, 2009-2013 ($ MILLIONS)
CREATIVE DIAGNOSTICS
BRIEF HISTORY
PRODUCT
Human Inhibin A (INH-A) ELISA Kit
CUSABIO
BRIEF HISTORY
PRODUCT
Inhibin A INH-A ELISA Kit
DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS INC.
BRIEF HISTORY
PRODUCT
PAPP-A ELISA Kit
DEMEDITEC DIAGNOSTICS GMBH
BRIEF HISTORY
PRODUCT
Inhibin A ELISA
DRAGERWERK AG & CO.
BRIEF HISTORY
PRODUCTS
Oxylog 1000
Oxylog 2000 Plus
Oxylog 3000 Plus
Drager TI500 Globe-Trotter Neonatal Transport System
Evita XL
Evita V300
DRE INC.
BRIEF HISTORY
PRODUCTS
DRE Compact Fetal Monitor
DRE Compact Plus Fetal Monitor
DRE Envoy F/M Central Monitoring System
DRG INTERNATIONAL INC.
BRIEF HISTORY
PRODUCT
DRG PAPP-A ELISA
EAGLE BIOSCIENCES INC.
BRIEF HISTORY
PRODUCT
Free Beta-hCG ELISA
ECARE MEDICAL TECHNOLOGY CO. LTD.
BRIEF HISTORY
PRODUCTS
EDAN INSTRUMENTS INC.
BRIEF HISTORY
PRODUCTS
Fetal and Maternal Monitor F9 Express
Fetal Monitor F9
Fetal Monitor F6
Fetal Monitor F3
Fetal Monitor F2
Ultrasonic Doppler SD3 Series (SD3, SD3 Lite, SD3 Plus and SD3 Pro)
Ultrasonic Pocket Doppler SonoTrax Series (SonoTrax Lite, SonoTrax
Basic, SonoTrax Basic A, SonoTrax Pro, SonoTrax II and SonoTrax Pro II)
Ultrasonic Doppler SD6
Wired Ultrasonic Tabletop Doppler SD5
Central Monitoring System MFM–CNS
ESAOTE SPA
BRIEF HISTORY
ULTRASOUND PRODUCTS FOR WOMEN'S HEALTH
MyLab Twice
MyLab ClassC
MyLab GOLD Platform
MyLab 50
MyLab 40
MyLab 25 Gold
FUKUDA DENSHI CO. LTD.
BRIEF HISTORY
PRODUCTS
DS-7700 Dynascope Central Monitor
UF-400AX Digital Portable Ultrasound Scanner
UF-550XTD Full Digital Ultrasound Scanner
UF-760 AG PaoLus Full Digital Color Portable Ultrasound Scanner
UF780AG Full Digital Ultrasound Scanner
REVENUE HISTORY
TABLE 67 FUKUDA DENSHI'S REVENUES, THROUGH MARCH 2014 (Yuan MILLIONS)
GE HEALTHCARE LTD.
BRIEF HISTORY
PRODUCTS
Corometrics 250CX Series Maternal and Fetal Monitor
Corometrics 170 Series Fetal Monitor
Mini Telemetry System
Ultrasound Systems
Vscan Pocket Ultrasound
Vscan with Dual Probe
LOGIQ P5
LOGIQ P6
Venue 50
Venue 40
LOGIQ S8
LOGIQ E9
LOGIQ e Ultrasound-2014
LOGIQ e Ultrasound BT12
MRI Systems
Discovery MR750w 3.0T
Optima MR450w 1.5T with GEM Suite
Silent Scan
Optima MR360 Advance
Brivo MR355 Inspire
Discovery MR750 3.0T
Optima MR450w
Optima MR360 1.5T
Brivo MR355 1.5T
Signa HDxt 3.0T
Signa HDxt 1.5T
REVENUE HISTORY
TABLE 68 GE HEALTHCARE'S REVENUES, THROUGH 2013 ($ MILLIONS)
GENE DIAGNOSTIX INC.
BRIEF HISTORY
PRODUCTS
NGS 24
NGS 24 Plus
NGD PGD
GD Basic
GD Premium
GD Custom
GENERAL MEDITECH INC.
BRIEF HISTORY
PRODUCTS
G6B/G6B Plus Fetal/Maternal Monitor
G6A/G6A Plus Fetal/Maternal Monitor
GENWAY BIOTECH INC.
BRIEF HISTORY
PRODUCTS
Free Beta-Subunit of Human Chorionic Gonadotropin (Free beta–hCG)
Test
GUANGZHOU SUNRAY MEDICAL APPARATUS CO. LTD.
BRIEF HISTORY
PRODUCTS
Fetal Monitor SRF618B5
Fetal Monitor SRF618B++
Fetal Monitor SRF618B
Maternal and Fetal Monitor SRF618K9
Fetal Heart Rate Doppler SRF618D
Fetal Heart Rate Doppler SRF618E
GUOTENG SCIENCE AND TECHNOLOGY DEVELOPMENT CO. LTD.
BRIEF HISTORY
PRODUCTS
GT9001 Fetal Monitor
Maternal Monitor
HITACHI MEDICAL SYSTEMS AMERICA INC.
BRIEF HISTORY
PRODUCTS
Ultrasound Systems
Arietta 70
ProSound Alpha 7
Noblus
ProSound F37
ProSound Alpha 6
ProSound F75
HOLOGIC INC.
BRIEF HISTORY
PRODUCT
Fetal Fibronectin (fFN) Test
REVENUE HISTORY
TABLE 69 HOLOGIC'S REVENUES, 2009-2013 ($ THOUSANDS)
HUNTLEIGH HEALTHCARE LLC.
BRIEF HISTORY
PRODUCTS
Sonicaid BD4000xs Series - Entry Level Fetal Monitor
Smartsigns SC750 Combo
Sonicaid Team Series
Sonicaid FM 800 Encore Series
Sonicaid Fetal Assist
Sonicaid Cordflow Assist
ILLUMINA INC.
BRIEF HISTORY
PRODUCTS
Verifi
REVENUE HISTORY
TABLE 70 ILLUMINA'S REVENUE, 2010-2013 ($ THOUSANDS)
INFINIUM MEDICAL INC.
BRIEF HISTORY
PRODUCTS
Omniview Central Station
INSTITUTE OF ISOTOPES CO. LTD.
BRIEF HISTORY
PRODUCTS
Beta-hCG ELISA Kit (EK-76)
LEINCO TECHNOLOGIES INC.
BRIEF HISTORY
PRODUCT
Alfa-1 Fetoprotein (AFP) Micro-ELISA Test Kit
LIFEWAVE BIOMEDICAL INC.
BRIEF HISTORY
PRODUCTS
LifeWave FetalConnect
UWB Medical Radar Technology
Postpartum Hemorrhage Detection
LUTECH INDUSTRIES INC.
BRIEF HISTORY
PRODUCTS
Datalys 500
Datalys 500UD
Datalys 500 Maternal
Datalys 750P
Datalys 750
Datalys 760
Datalys 780
Datalys 730
Datalys 790
LT8500 Laptop Ultrasound
LT8510 Tablet Ultrasound
LT100 Digital Video Colposcope System
LT300 Digital Video Colposcope System
M&B ELECTRONIC INSTRUMENTS CO. LTD.
BRIEF HISTORY
PRODUCTS
M1720a Fetal Monitor
M1720A Fetal Monitor
MEDGYN PRODUCTS INC.
PRODUCTS
MedGyn Fetal Monitor F6
MedGyn Fetal Monitor F9
Ultrasonic Pocket Doppler
Ultrasonic Tabletop Doppler
ECO 3 Ultrasound
D3 Ultrasound
Q8 Color Ultrasound System
Q5 Color Ultrasound System
8300 Black and White Ultrasound System
MEDIANA CO. LTD.
BRIEF HISTORY
PRODUCTS
FM 20 Fetal Monitor
F 10 Fetal Doppler
MEDICAL ECONET GMBH
BRIEF HISTORY
PRODUCTS
ECOsound
ECOtwin LCD
ECOtwin LED
Insight
Insight Lite
Smart 1
Smart 3
Smart 5
MEDICHECKS LTD.
BRIEF HISTORY
PRODUCT
Beta-hCG (Qualitative)
MINDCHILD MEDICAL INC.
BRIEF HISTORY
PRODUCT
Meridian Monitor
MINDRAY MEDICAL INTERNATIONAL LTD.
BRIEF HISTORY
PRODUCT
TMS-6016 Telemetry Monitoring System
Hypervisor VI Central Monitoring System
eGateway Integration Manager
REVENUE HISTORY
TABLE 71 MINDRAY'S REVENUE, 2009-2013 ($ THOUSANDS)
MONICA HEALTHCARE LTD.
BRIEF HISTORY
PRODUCTS
Monica AN24
Monica IF24
Monica VS Program
Monica DK
MONOBIND INC.
BRIEF HISTORY
PRODUCT
AccuLite CLIA and AccuBind ELISA
MYRIAD GENETICS INC.
BRIEF HISTORY
PRODUCTS
Myriad myRisk Hereditary Cancer Panel
Myriad myPath Melanoma
Myriad myPlan Lung Cancer
Polaris
Vectra DA
BRACAnalysis
Colaris
Panexia
Prezeon
NATERA INC.
BRIEF HISTORY
PRODUCTS
Panorama Test
Clinical Data for Panorama Test
TABLE 72 CLINICAL DATA FOR PANORAMA TEST (%)
Minimal False Negatives in Panorama Tests
FIGURE 22 FALSE NEGATIVE RATES FOR DIFFERENT GENETIC DIAGNOSTIC TESTS (%)
Error Rates in Fetal Sex Determination
FIGURE 23 ERROR RATES IN FETAL SEX DETERMINATION (%)
Horizon Multi-Disease Carrier Screening
Spectrum Preimplantation Genetic Screening (PGS) and Preimplantation
Genetic Diagnosis (PGD)
Anora Miscarriage Testing
Prenatal Paternal Test
NATUS MEDICAL INC.
BRIEF HISTORY
FETAL MONITORING PRODUCTS
Nicolet Elite
FreeDop
ImexDop CT+
Pocket-Dop 3
Pocket-Dop II
VersaLab APM and APM2
VersaLab LE and SE
REVENUE HISTORY
TABLE 73 NATUS MEDICAL'S REVENUE HISTORY, 2009-2013 ($ THOUSANDS)
NEMO HEALTHCARE BV
BRIEF HISTORY
PRODUCTS
PUREtrace
NEOVENTA MEDICAL AB
BRIEF HISTORY
PRODUCTS
Stan S31
ST Analysis
StanViewerLive
StanViewer
Goldtrace
NIHON KOHDEN CORP.
BRIEF HISTORY
PRODUCTS
CNS-6201 Central Monitor
CNS-9601 Central Monitor
WEP-5204 and WEP-5208 Telemetry Systems
REVENUE HISTORY
TABLE 74 NIHON KOHDEN'S REVENUE, 2010-MARCH 2014
(¥THOUSANDS)
NONIN MEDICAL INC.
BRIEF HISTORY
PRODUCTS
Onyx II 9560 Wireless Finger Pulse Oximeter
Onyx II 9550 Finger Pulse Oximeter
OB TOOLS LTD.
BRIEF HISTORY
PRODUCTS
Electro Uterine Monitor EUM-100 Pro
PENLON LTD.
BRIEF HISTORY
PRODUCTS
Hypervisor VI CMS
PERKINELMER LIFE AND ANALYTICAL SCIENCES INC.
BRIEF HISTORY
PRODUCTS
DELFIA TRF Assays
AutoDELFIA Automatic Immunoassay System
DELFIA Xpress PAPP–A Kit
Dries Blood Spot (DBS) Kits
PHOENIX PHARMACEUTICALS INC.
BRIEF HISTORY
PRODUCT
Free Beta–hCG ELISA Kit
RAVGEN
BRIEF HISTORY
PRODUCTS
Prenatal Down syndrome Testing
Single Gene Disorder Testing
PREMAITHA HEALTH LTD.
BRIEF HISTORY
PRODUCT
IONA Test
QUEST DIAGNOSTICS INC.
BRIEF HISTORY
SERVICES
RAYBIOTECH INC.
BRIEF HISTORY
PRODUCT
Custom Human PAPP-A ELISA
REPRODUCTIVE RESEARCH TECHNOLOGIES LP
BRIEF HISTORY
PRODUCTS
SureCALL Labor Monitor
SureTOUCH Collascope
REPROGENETICS LABORATORIES
BRIEF HISTORY
SERVICES
Comprehensive Chromosome Screening
Single Gene Disorder Testing
RESPIRONICS INC. (PHILIPS)
BRIEF HISTORY
PRODUCTS
920M Plus Hand-Held Oximeter
Wrist Ox2 Wrist-Worn Pulse Oximeter
GO2 Pulse Oximeter
CoughAssist T70
BiPAP AVAPS
BiPAP S/T
Trilogy200
Trilogy100
SEQUENOM INC.
BRIEF HISTORY
PRODUCTS
MaterniT21 PLUS
NextView Array Test
TABLE 75 NEXTVIEW DIAGNOSTIC TEST PLATFORMS
Fetal RHD Genotyping Test
Cystic Fibrosis Carrier Screening
SHENZHEN AEON TECHNOLOGY CO. LTD.
BRIEF HISTORY
PRODUCTS
A100C Portable Fetal Doppler and A100d Fetal Doppler Heart Rate
Monitor
A100S Desktop Fetal Doppler
A100B Fetal Monitor
A100C Portable Fetal Doppler
SHENZHEN COMEN MEDICAL INSTRUMENTS CO. LTD.
BRIEF HISTORY
PRODUCTS
C60 Neonatal Patient Monitor
Star 5000E Fetal Monitor
Star 5000D Fetal Monitor
Star 500C Maternal and Fetal Monitor
Star 500B Maternal and Fetal Monitor
Star 5000A Fetal Doppler
Star 6000 Fetus ECG Monitor
SHENZHEN JUMPER MEDICAL EQUIPMENT CO. LTD.
BRIEF HISTORY
PRODUCTS
Fetal Doppler JPD-100B+
Fetal Doppler JPD-100B
Fetal Doppler JPD-200C
Fetal Doppler JPD-100T
Fetal Monitor JPD-300P (12.1 inches)
Fetal Monitor JPD-300P (7 inches)
Maternal and Fetal Monitor JPD–600P (7 inches)
Maternal and Fetal Monitor JPD–600P (12 inches)
Long Distance Fetal Monitoring System JPD-300K
SIEMENS HEALTHCARE
BRIEF HISTORY
OBSTETRIC AND GYNECOLOGICAL ULTRASOUND PRODUCTS
ACUSON S3000
ACUSON S2000
ACUSON S1000
ACUSON X700
ACUSON X300PE
ACUSON X150
ACUSON Antares
ACUSON P300
ACUSON P10
IMMULITE Free Beta-hCG Assay
REVENUE HISTORY
TABLE 76 SIEMENS' REVENUE, THROUGH 2013 (€ MILLIONS)
SINOHERO BIOMEDICAL ELECTRONICS CO. LTD.
BRIEF HISTORY
PRODUCTS
SMITHS MEDICAL INC.
BRIEF HISTORY
PRODUCTS
Portex Latex Hyperinflation Systems
Portex 1st Response Infant Manual Resuscitators
BCI Autocorr Digital Pulse Oximeter
Digit Finger Oximeter
SPACELABS HEALTHCARE INC.
BRIEF HISTORY
PRODUCTS
Sonicaid Encore Intrapartum
TOSHIBA AMERICA MEDICAL SYSTEMS INC.
BRIEF HISTORY
ULTRASOUND SYSTEMS
Aplio 500
Aplio 300
Xario 200
Viamo
USCN LIFE SCIENCES INC.
BRIEF HISTORY
PRODUCT
ELISA Kit for Inhibin A (INHA)
ULTRASOUND TECHNOLOGIES LTD.
BRIEF HISTORY
PRODUCTS
Fetatrack 310
Fetatrack 360 Cardiotocograph
Fetal Doppler PD1, PD1+ and PD1 dwr
UNITED BIORESEARCH INC.
BRIEF HISTORY
PRODUCT
Unconjugated E3 (uE3)
UTAH MEDICAL PRODUCTS INC.
BRIEF HISTORY
PRODUCTS
OvaCue Fertility Monitor
Toco Abdominal Belts
Fetal Scalp Electrodes
VCOMIN TECHNOLOGY LTD.
BRIEF HISTORY
PRODUCTS
Lovebaby 100A
FD-200A
FD-300C
FD-800D and FD-800C
FM-800A
FM-321 and FM-322
FM-311 and FM-312
VERINATA HEALTH INC.
BRIEF HISTORY
PRODUCTS
Verifi Prenatal Test
WALLACH SURGICAL DEVICES INC.
BRIEF HISTORY
FETAL MONITORS
Fetal2EMR Fetal Monitor
Fetal2EMR Insight Software
FETAL DOPPLERS AND PROBES
LifeDop 150
LifeDop 250 Series
LifeDop 350 Series
LifeDop Non-Directional Obstetrical Probes
WELCH ALLYN INC.
BRIEF HISTORY
PRODUCTS
Acuity Central Monitoring Station
Connex Central Station

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