đź“‹ FDA Reference

philips biosensor bx100

Philips Medical Systems

Summary: The Philips Biosensor BX100 is a wearable biosensor used for continuous monitoring of physiological parameters, primarily by healthcare professionals in hospital settings. It aids in patient monitoring and management.

FDA Clearance Information

Pathway 510K
Decision Date April 16, 2020
Product Code DRG
Device Class Class 2
Evidence 419 studies

The Philips Biosensor BX100 was cleared through the FDA 510(k) pathway on April 16, 2020. Manufactured by Philips Medical Systems, it is classified as a Class 2 device under product code DRG.

What It Is

The Philips Biosensor BX100 is a wearable device designed to continuously monitor vital signs such as heart rate and respiratory rate. It uses advanced sensor technology to provide real-time data to healthcare providers, facilitating timely clinical decisions. The device is typically worn on the patient's chest and transmits data wirelessly to a monitoring system.

Clinical Applications

This biosensor is commonly used in hospital settings, particularly in general wards and step-down units, where continuous monitoring is essential but traditional ICU monitoring is not required. It is beneficial for patients who are at risk of deterioration, such as those with cardiac or respiratory conditions. The device supports clinicians in early detection of patient deterioration, allowing for timely intervention.

Indications for Use

The FDA-cleared indications for the Philips Biosensor BX100 involve its use in monitoring physiological parameters in patients who require continuous observation. It is particularly suitable for patients with conditions that may lead to embolization or other complications.

Practical Considerations

The Philips Biosensor BX100 is designed for ease of use with a simple application process. It is compatible with various hospital monitoring systems, allowing seamless integration into existing workflows. Clinicians should ensure proper placement and secure attachment to optimize data accuracy.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 is Philips Biosensor BX100 used for?

It is used for continuous monitoring of vital signs such as heart rate and respiratory rate in hospital settings.

What specialties typically use this device?

Specialties such as internal medicine, cardiology, and respiratory care commonly use this device.

What are the FDA-cleared indications?

The device is indicated for monitoring physiological parameters in patients who require continuous observation, particularly those at risk of embolization or other complications.

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.