The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.
The catheter is part of the company’s transcatheter pulmonary valve system.
The pandemic forced patients and providers to rely on telemedicine, a change that has had a significant impact on the course of care. Experts discuss what can be accomplished with virtual care and what this means for the potential of medical devices.
The short answer is yes, but doing your homework in advance is now more important than ever.
Outdated policies and regulations threatens to bring progress to a standstill, restrict vital telehealth access to millions of Americans, and exacerbate health inequities.
On the journey to full-scale production for medical devices incorporating optics, a series of steps early in the process can make all the difference for successfully launching new products and introducing next-generation upgrades. This article discusses four considerations for a successful product launch.
You’d think there’s not much to the concept of an alarm. A warning sounds in a room, or a red light flashes, and it has your attention. You know something must be wrong. But in a setting where a cacophony of alarming lights and sounds beset healthcare workers on a regular basis, these essential systems become increasingly easy to miss or ignore.
Patient-administered healthcare is one of the fastest-growing segments in the medtech industry. When the patient becomes the operator, usability requirements are vastly different than those of trained clinicians, which elevates considerations in the design process.
With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.
The long-awaited part 23 of ISO 10993, the series of standards governing Biological Evaluation of Medical Devices, was published in January 2021. It was the first to introduce validated methods for in-vitro irritation tests. This article reviews the latest developments and identifies the cases in which manufacturers can avoid animal experiments.
