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, so does the need to consider nonlinear acoustic parameters as part of QA processes. These advanced metrics provide deeper insights into probe performance, elevating both probe sensitivity and diagnostic … Continue reading
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 to performance testing has never been ideal, but with the FDA’s Final Guidance on remanufacturing and servicing for medical devices, it’s no longer an option. A repaired probe must not … Continue reading
The Corner Office Wayne Moore 11/11/2024 I was honored in October to give a presentation at the Clinical Engineering Association of Illinois (CEAI). The presentation was focused on how to read an FDA Guidance document in order to use the information gleaned from reading it as a template for vetting potential third-party service providers. The … Continue reading
Tell us a little about yourself and what is your role at Acertara? As a Colorado native, I enjoy running, hiking, and climbing. My family is a huge part of my life: I have 6 siblings, 2 older brothers, and 4 younger sisters. My mom homeschooled all of us — she is a saint! I’ve … Continue reading
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 question: How will quality assurance in ultrasound technology look for PoCUS devices? As handheld PoCUS devices become more prevalent, questions surrounding their clinical accuracy and the need for robust … Continue reading
Tell us a little about yourself and your role at Acertara? I’m originally from the Northeast and have lived in Massachusetts, New Hampshire, and Vermont. I’ve been in Colorado for a little over two years now. When I’m not at work, I’m usually outside skiing or biking. At Acertara, I work as a design engineer, … Continue reading
The Corner Office Wayne Moore 9/16/2024 If nothing else, the R2R movement in the medical device space is making lawyers richer and litigants poorer, in so many ways. The majority of recent lawsuits involving the general heading of Right-to-Repair are centered around the larger issue of intellectual property (IP). Most of these lawsuits, therefore, have … Continue reading
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 continue to evolve, so does the importance of maintaining these devices to ensure consistent, high-quality results. When it comes to ultrasound probe repair, transparency and trust between healthcare providers … Continue reading
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 compliance. Among the regulatory bodies involved, the U.S. Food and Drug Administration (FDA) is ever at the forefront. Their guidance impacts every facet of ultrasound device development — from … Continue reading
The Corner Office Wayne Moore 9/16/2024 With the introduction and rapid diffusion of handheld Point-of-Care (POC) ultrasound devices, questions concerning the role and definition of routine quality assurance testing of those devices in clinical use have become a hot topic in several professional ultrasound societies such as the American Institute of Ultrasound in Medicine (AIUM), … Continue reading