đź“Š Evidence-Based Reference
Philips Easyguide Neuro
Philips Medical Systems
Summary: The Philips EasyGuide Neuro is a frameless stereotactic navigation device used in neurosurgery. It aids in precise anatomical targeting. Key evidence highlights its use in image-guided procedures with anatomical landmarks.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K961834 ↗
Decision Date ?
November 8, 1996
Product Code ?
HAW
Device Class ?
Class 2
Evidence ?
419 studies
The Philips EasyGuide Neuro was cleared by the FDA through the 510(k) pathway on November 8, 1996. It is manufactured by Philips Medical Systems and classified as a Class 2 device.
What It Is
The Philips EasyGuide Neuro is a frameless stereotactic navigation system designed for neurosurgical procedures. It utilizes anatomical landmarks for image registration, facilitating precise targeting during surgery.
FDA-Cleared Indications
- Used for frameless stereotactic localization and navigation during neurosurgical procedures.
- Uses anatomical landmarks for image registration and target localization.
- Intended to assist surgeons with precise anatomical targeting when frame-based stereotactic systems are impractical.
Clinical Applications
- Image-guided neurosurgical procedures requiring precise localization of an intracranial target.
- Frameless stereotactic targeting based on anatomical landmarks.
- Surgical targeting for procedures such as trigeminal neuralgia treatment when the system is used according to its cleared labeling.
- Target localization for interstitial brachytherapy when performed according to the device labeling.
Evidence Summary
The available literature includes four studies ranging from 1998 to 2002, comprising prospective and other study types. These studies explore the device's application in various neurosurgical contexts.
Reported Outcomes
Published studies report the device's efficacy in enhancing surgical precision through image-guided navigation. It has been used successfully in procedures like transcallosal microsurgery and brachytherapy, demonstrating improved planning and execution.
Safety Profile
Reported complications include potential postoperative epilepsy associated with certain surgical approaches. However, specific safety data from the studies is limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and broader clinical applications.
Practical Considerations
- The system depends on accurate image registration and reliable identification of anatomical landmarks; registration errors can reduce targeting accuracy.
- It is a navigation system rather than an implantable device, so compatibility with imaging systems, tracking components and operating-room equipment must be confirmed before use.
- The available FDA record does not establish that the system or its tracking components are MRI safe or MRI conditional; users should follow the manufacturer’s labeling and site-specific MRI safety policies.
- Patient movement, brain shift, changes in anatomy and obstruction of tracking markers can affect navigation accuracy.
- Use requires trained neurosurgical personnel and verification of target localization before tissue sampling, ablation, radiation delivery or other therapy.
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 EasyGuide Neuro?
The device is indicated for use in neurosurgical procedures requiring precise anatomical targeting, such as embolization and brachytherapy.
What outcomes have been reported in clinical studies?
Studies report improved surgical precision and planning in procedures like transcallosal microsurgery and brachytherapy.
What complications have been reported?
Reported complications include potential postoperative epilepsy, though specific safety data is limited.
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.