The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...

Today’s medical devices are very sophisticated, with more providers serving applications in software as well as hardware. These devices are becoming more intelligent and can be tailored to be ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

At a time when medical technology breakthroughs often stall long before reaching patients, Northwestern University’s Querrey Simpson Institute for Bioelectronics (QSIB) has become a striking exception ...

A rendering of Aggie Square, the UC Davis science, innovation and learning hub in Sacramento. The UC Davis Department of Biomedical Engineering is launching a new nine-month master’s degree program in ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

Academia converts research dollars into a variety of benefits that exemplify the return on investment. A continuous flow of graduates who contribute to industry goals upon earning a degree from their ...

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...

Some medical technologies are just plain cool. But tech that’s only cool is never enough. It must solve specific health problems, improve each patient’s quality of care, and be easy to use. To create ...

Quarterly earnings results are a good time to check in on a company’s progress, especially compared to its peers in the same ...