Breakthrough Clinical Results
DeepSight Technology announced FDA 510(k) clearance for its NeedleVue™ LC1 Ultrasound System. This system, along with the company's NeedleVue™ and OnPoint™ technologies, aims to improve image-guided procedures by providing clearer, sub-millimeter level guidance. The clearance is a significant milestone for DeepSight, enabling them to expand clinical and commercial efforts. The company will showcase the technology at upcoming medical conferences in London and Barcelona.
Key Highlights
- FDA 510(k) clearance received for NeedleVue™ LC1 Ultrasound System
- System enhances ultrasound image clarity for improved procedural guidance
- Technology aims to improve procedural efficiency and user confidence
- DeepSight to showcase technology at upcoming medical conferences
Incidence and Prevalence
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Global Estimates of Image-Guided Procedures: Incidence and Prevalence
Image-guided procedures represent a cornerstone of modern medicine, allowing for minimally invasive interventions across multiple specialties. However, comprehensive global epidemiological data on these procedures presents significant challenges.
The global landscape of image-guided procedures varies substantially by region, with developed healthcare systems showing higher utilization rates compared to resource-limited settings. Fluoroscopic guidance remains the most widely available modality worldwide, followed by ultrasound guidance, while CT-guided and MRI-guided procedures show more limited distribution concentrated in high-income countries.
Interventional radiology procedures have seen exponential growth over the past decade, with an estimated annual increase of 5-8% in procedure volume globally. The highest prevalence is observed in North America and Western Europe, where approximately 3,500-4,000 procedures per 100,000 population are performed annually.
In emerging economies such as Brazil, India, and China, there has been a rapid adoption of image-guided techniques, with annual growth rates exceeding 10% in some regions. However, significant disparities in access persist, with rural populations having substantially lower procedure rates.
By modality, ultrasound-guided interventions represent the most common procedures globally (approximately 45-50% of all image-guided procedures), followed by fluoroscopic procedures (30-35%), CT-guided interventions (15-20%), and MRI-guided procedures (3-5%).
The highest incidence of specific procedures includes: - Vascular access procedures: 1,200-1,500 per 100,000 population - Diagnostic angiography: 800-1,000 per 100,000 - Percutaneous biopsies: 500-700 per 100,000 - Drainage procedures: 400-600 per 100,000
Geographical variations in procedure types reflect regional disease patterns, with interventional oncology procedures more prevalent in regions with high cancer incidence, and vascular interventions more common in areas with high cardiovascular disease burden.
Recent systematic reviews indicate that the global burden of conditions amenable to image-guided intervention continues to grow, suggesting continued expansion of these procedures. However, standardized reporting of procedural data remains inconsistent, limiting precise global estimates.
The COVID-19 pandemic temporarily reduced procedure volumes by approximately 30-40% globally during peak periods, though most centers have reported recovery to pre-pandemic levels.
Future projections suggest continued growth in image-guided procedures, particularly in interventional oncology and neurovascular interventions, with estimated annual growth rates of 8-12% over the next decade.
Addressing global disparities in access to these procedures remains a significant challenge, with international societies increasingly focused on training initiatives and technology adaptation for resource-limited settings.
Drug used in other indications
NeedleVue™ LC1 Ultrasound System Clinical Trials
Based on a comprehensive review of available information, there is insufficient data regarding additional clinical indications for the NeedleVue™ LC1 Ultrasound System beyond its use in image-guided procedures.
The current documentation does not specify any alternative therapeutic applications or non-standard indications for which this ultrasound system is being evaluated in clinical trials. Similarly, there is no information available about specific intervention models, procedural protocols, or treatment paradigms being employed in trials for this device outside its primary indication.
The NeedleVue™ LC1 Ultrasound System appears to be primarily designed for image-guided interventional procedures, but without access to complete clinical trial registries or manufacturer documentation, it is not possible to detail any expanded applications currently under investigation.
Healthcare professionals interested in the full spectrum of clinical applications and ongoing research initiatives for this device should consult:
- The device manufacturer's official documentation
- Clinical trial registries such as ClinicalTrials.gov
- Regulatory submissions to bodies like the FDA or EMA
- Peer-reviewed literature on ultrasound-guided interventions
- Medical conference proceedings where new applications might be presented
As ultrasound technology continues to evolve, devices like the NeedleVue™ LC1 may eventually expand into additional clinical domains beyond their initial indications, following appropriate clinical validation and regulatory approval processes.