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Philips Avalon Fetal Maternal Monitors FM20 FM30 FM40 and FM50
Philips Medizin Systeme Boblingen
Summary: The Philips Avalon fetal maternal monitors are used for continuous monitoring of fetal and maternal parameters during labor. Key evidence highlights their role in improving patient comfort and signal quality in noninvasive monitoring.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140535 ↗
Decision Date ?
November 25, 2014
Product Code ?
HGM
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Avalon fetal maternal monitors were cleared by the FDA through the 510(k) pathway on November 25, 2014. Manufactured by Philips Medizin Systeme Boblingen, they are classified as Class 2 devices.
What It Is
The Philips Avalon fetal maternal monitors are medical devices designed to continuously monitor fetal heart rate and maternal uterine activity. They utilize advanced technology to provide accurate and reliable data, aiding in the assessment of fetal well-being during labor.
FDA-Cleared Indications
- Monitoring fetal heart rate.
- Monitoring maternal heart rate and other maternal vital signs.
- Monitoring uterine activity during labor.
- Monitoring fetal and maternal parameters simultaneously.
Clinical Applications
- Continuous fetal heart-rate monitoring during labor.
- Noninvasive monitoring of maternal heart rate and vital signs during labor.
- Monitoring maternal uterine activity, including contractions.
- Simultaneous fetal and maternal monitoring when assessment of both patients is needed.
Evidence Summary
The available literature includes six studies, comprising various study types such as RCTs and prospective analyses, conducted between 2018 and 2025. These studies explore different aspects of fetal monitoring technologies, including patient experiences and device performance.
Reported Outcomes
Published studies report that the Philips Avalon monitors enhance patient comfort and provide high-quality signal acquisition for fetal heart rate monitoring. They are effective in prolonged monitoring scenarios, offering improved patient experience compared to traditional methods.
Safety Profile
Reported complications include minimal adverse events, with studies focusing more on patient comfort and device performance rather than safety issues. The evidence suggests that these monitors are generally safe for use in clinical settings.
Evidence Limitations
The evidence base is limited by a lack of large-scale studies directly comparing different fetal monitoring technologies. Further research is needed to explore long-term outcomes and the impact of these devices on clinical decision-making.
Practical Considerations
- The FM20, FM30, FM40, and FM50 are monitor systems used with compatible fetal and maternal sensors, transducers, cables, and accessories; compatibility should be confirmed before use.
- External monitoring may be affected by fetal movement, maternal movement, signal loss, body habitus, sensor placement, or interference from other equipment.
- The monitor provides physiologic measurements and does not replace clinical assessment or confirm fetal well-being by itself.
- MRI compatibility depends on the specific monitor, sensor, transducer, cable, and accessory. These devices should not be taken into an MRI environment unless Philips labeling specifically permits it.
- Sensors and accessories should be cleaned, disinfected, stored, and replaced according to the manufacturer’s instructions and the condition of the equipment.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Philips Avalon fetal maternal monitors?
These monitors are indicated for continuous monitoring of fetal heart rate and maternal uterine activity during labor and delivery.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved patient comfort and high-quality signal acquisition, making these monitors suitable for prolonged monitoring.
What complications have been reported?
Reported complications include minimal adverse events, with a focus on patient comfort and device performance in the available studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.