The FDA’s Final Guidance on repair versus remanufacturing of medical devices has important implications for hospital suppliers. It goes beyond simple terminology — new definitions and requirements have real impacts on patient safety and hospital liability. Misinformation can lead to reputational damage and even legal repercussions. Understanding the key differences between repair and remanufacturing — … Continue reading
Recent FDA guidance on remanufacturing medical devices has shed light on the crucial distinction between repair and remanufacturing activities. Ensuring proper maintenance and repair of reusable medical devices is essential for both patient safety and continued functionality throughout equipment lifespan. Navigating the new guidelines and complying with the testing requirements can be a challenge for … Continue reading
In medicine, ensuring the safety and efficacy of equipment is paramount. From complex surgical tools to diagnostic instruments, medical devices play a crucial role in patient care — and the U.S. Food and Drug Administration (FDA) is at the forefront of mandating requirements to govern them. Specifically, the FDA releases guidance that sets the tone … Continue reading
In a perfect vision of society, healthcare would be universally accessible, with timely and effective treatment available to all. Yet the reality is often marred by challenges such as geographic isolation, financial constraints, and a scarcity of resources, all of which hinder access for many communities. Amid these challenges, advancements in medical technology are emerging … Continue reading
If the digital age has taught us anything, it’s that information is valuable — and powerful. This has always been a fundamental truth in the world of healthcare. Today, we’re seeing a marriage of digital capabilities and healthcare philosophies in pursuit of improving patient care. Nowhere is this more evident than within the scope of … Continue reading
Ultrasound is a tried-and-true technology, applicable across a spectrum of clinical applications. It’s becoming more critical with the shift toward value-based care (VBC). Today’s technology offers decisive point-of-care ultrasounds, delivery, and treatment monitoring as part of complex care plans. Yet, unlocking the full potential of ultrasound in VBC requires more than just a skilled hand … Continue reading
Healthcare is in a period of necessary evolution, with traditional fee-for-service models giving way to a focus on delivering value: providing improved outcomes at lower costs. This journey requires innovative tools, and one imaging technology stands out: ultrasound. Its accuracy, efficiency, accessibility across a myriad of clinical applications, and lower cost are proving remarkably suited … Continue reading
Point-of-care ultrasound (PoCUS) has rapidly gained traction in healthcare for its capacity to prompt faster diagnosis and treatment decisions. Still, the integration of PoCUS into regular healthcare practices raises important regulatory and ethical considerations. What constitutes appropriate training and certification for administering PoCUS procedures? How will equipment be repaired, and to what quality standards should … Continue reading
Ultrasound technology — a longtime staple in medical imaging — is now emerging as a pivotal tool in the evolution of point-of-care diagnostics. This leap forward is marked by accessible applications, noninvasive procedures, and real-time results. As ultrasound becomes increasingly sophisticated, with AI-enabled workflow intelligence and devices designed for portability, its role in enhancing patient … Continue reading
When it comes to ultrasound scans, image fidelity is paramount. While ultrasound clarity has improved by leaps and bounds over the last few decades, not all progress can be attributed to better transducer materials and wave propagation innovations. An often overlooked area of innovation comes in the form of ultrasound ergonomics. Better form-factor design is … Continue reading
