The recent release of the FDA’s Final Guidance on remanufacturing of medical devices sent ripples through the healthcare industry. This is especially true for healthcare organizations (HCOs)...
Blog
What Hospitals Need To Know About FDA Guidance on Medical Device Repair
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...
Acertara: Your Partners in Compliance With FDA Guidance
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...
Why the FDA’s Final Guidance on Remanufacturing Is a Boon for Patient Safety
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....
How Ultrasound Accessibility is Growing Through Cost Effective Diagnostics & Treatment
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...
Providing Safer Medtech Solutions with Portable Ultrasounds & Reduced Ionizing Radiation
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...
Technical Expertise in Ultrasound Engineering Translates to Value-Based Care
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...
Value-Based Care and Ultrasound Diagnostics: A Win-Win for Patients
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...
Point-of-Care Ultrasound: Regulatory and Ethical Considerations
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...
The Future of Point-of-Care & Ultrasound Diagnostics
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...
Ergonomics in Ultrasound Device Design
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...
Ultrasound Engineering: Sound Wave Propagation and Image Clarity
Research and Development is a cornerstone of healthcare innovation: striving to overcome the challenges and limitations of today’s most relied-upon medical devices. In the realm of ultrasound...