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philips wearable biosensor-g5 solution
Connected Sensing- A Division Of Philips Medical Systems
Summary: The Philips Wearable Biosensor-G5 Solution is a clinician-facing device designed for continuous monitoring of vital signs. It is primarily used for early detection of clinical deterioration. Key evidence highlights its role in reducing severe adverse events.
FDA Clearance Information
Pathway
510K
Number
K181165 ↗
Decision Date
March 7, 2019
Product Code
DRT
Device Class
Class 2
Evidence
419 studies
The Philips Wearable Biosensor-G5 Solution was cleared via the FDA 510(k) pathway on March 7, 2019. It is manufactured by Connected Sensing, a division of Philips Medical Systems, and is classified as a Class 2 device under product code DRT.
What It Is
The Philips Wearable Biosensor-G5 Solution is a wearable device that continuously monitors vital signs such as heart rate and respiratory rate. It is intended for use in hospital settings to aid in the early detection of patient deterioration.
Clinical Applications
Commonly used in general hospital wards, the device helps clinicians monitor patients who are at risk of clinical deterioration. It provides continuous data that can inform timely interventions and potentially prevent severe adverse events.
Evidence Summary
The available literature includes 10 peer-reviewed studies, with a mix of study types such as RCTs and prospective studies, conducted between 2023 and 2025. These studies focus on the device's efficacy in monitoring vital signs and its impact on patient outcomes.
Reported Outcomes
Published studies report that the Philips Wearable Biosensor-G5 Solution significantly reduces severe adverse events by enabling early detection of clinical deterioration. The device's continuous monitoring capabilities have been shown to improve patient safety and reduce the need for ICU transfers.
Safety Profile
Reported complications include potential discomfort from wearing the device and occasional false alarms. However, no severe adverse events directly attributed to the device have been noted in the studies reviewed.
Evidence Limitations
Current evidence is limited by the relatively short duration of studies and the focus on specific clinical settings. Further research is needed to explore long-term outcomes and the device's applicability in diverse patient populations.
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 Wearable Biosensor-G5 Solution?
The device is indicated for continuous monitoring of vital signs to detect early signs of clinical deterioration in hospital settings.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in severe adverse events and improved patient safety due to early detection of deterioration.
What complications have been reported?
Safety data indicate potential discomfort from wearing the device and occasional false alarms, but no severe device-related adverse events.
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.