Heading into 2025, innovative medical imaging solutions are setting new benchmarks for healthcare providers, integrating advanced features and tools that enhance diagnostic capabilities across...
Blog
2024’s Compliance Updates for Quality Assurance in Ultrasound
The year 2024 marked significant advancements in regulatory frameworks for medical devices, especially ultrasound systems. The updates are not just about adhering to new rules but are a reminder of...
Advanced Algorithms for Ultrasound Image Quality Analysis
Algorithmic advancements are central to improving ultrasound image quality and ensuring robust quality assurance in ultrasound. As ultrasound probes undergo routine use, maintaining both imaging...
Nonlinear Acoustic Parameters in Ultrasound QA
Traditional quality assurance in ultrasound often centers on linear acoustic parameters, focusing on basic aspects of sound propagation and imaging resolution. But as ultrasound technology advances,...
Ultrasound Probe Repair: Application-Specific Performance Testing
Ultrasound probe repair services must evolve with the increasing complexity of new ultrasound systems, particularly in probes used for specialized clinical applications. A one-size-fits-all approach...
Quality Assurance in Ultrasound: New PoCUS Technology — and New Questions
The rise of handheld point-of-care ultrasound (POCUS) devices has introduced new possibilities in medical diagnostics. But with their widespread adoption comes an important and often overlooked...
Transparency and Trust in Ultrasound Probe Repair Services
The healthcare industry relies on accurate diagnostics, and ultrasound technology plays a pivotal role in delivering real-time imaging that aids in critical decision-making. As ultrasound systems...
FDA Guidance Shapes the Future of Ultrasound and Medical Device Repair Companies
The evolution of commercially available ultrasound technology is not solely driven by scientific innovation; it is closely intertwined with regulatory oversight that ensures safety, efficacy, and...
Technical Expertise for Compliant Ultrasound Repairs
As medical device repair companies navigate new compliance guidance, the need for specialized technical expertise has never been clearer. The FDA’s Final Guidance on medical device repairs mandates...
The Acertara Advantage: Precision Testing for Patient Safety
Precision testing plays a crucial role in the medical device industry, ensuring compliance with regulatory requirements and enhancing patient safety and treatment outcomes. In the field of...
Quantitative Testing for Ultrasound Devices
The FDA’s Final Guidance on medical device remanufacturing has underscored the critical need for quantitative testing. This type of testing is essential to ensuring compliance with their Guidance...
FDA Guidance Calls for Quantitative Testing
The U.S. Food and Drug Administration (FDA) recently issued Final Guidance on the definition and determination of what constitutes “remanufacturing” for reusable medical devices. This...