Medical device manufacturers in the US market are reporting mounting pressure to lower product prices as clients such as hospital groups seek to lower procurement costs and stem operating losses. According to a survey by hospital group purchasing organization Premier Inc. (via Dow Jones Newswire), hospitals have lost more than $1 billion due to high-cost medical devices and have indicated interest in purchasing lower-cost alternative products in the future.

The US Food and Drug Administration may reclassify external pacemaker pulse generators fr

US medical device industry lobbying efforts against current regulatory practices appear to be working.

A parallel review pilot program newly deployed by the US FDA and the Centers for Medicare & Medicaid Servic

Venture capital firms are investing less in US medical device and pharmaceutical companies in favor...

The US FDA’s Center for Devices and Radiological Health (CDRH) has launched a 12-week pilot program on it

The US Food and Drug Administration has published draft guidance establishing two pathways for medical...

Mobile medical app-related issued explicitly not covered by the recent FDA guidance’s scope include wireless safety, applying quality systems to software and regulatory requirements for clinical decision support (CDS) software. The agency has disclosed plans to address these issues in separate guidances, but has provided no further details on those plans.

Can minimally-staffed software application developers getting into the medical device sector reasonably be expected to comply with the same FDA requirements as medical device manufacturers?

During the US Food and Drug Administration’s two-day public workshop on its Mobile Medical Applications Draft Guidance held September 12 and 13, 2011, attendees and FDA officials wrestled with the issue of how to classify applications that serve as accessories to medical devices.