The US Food and Drug Administration (FDA) has requested public comment from health care providers until January 3, 2012 on its proposed

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has launched a new searc

Venture capitalists are spending significantly on efforts to lobby the US Congress to ease FDA regulatory requirements for medical device manufacturers, to considerable effect. According to a New York Times report, venture capital funds allocating to medical device and technology manufacturers have provided more than $3.3 million in political donations to lawmakers and political action committees over the past five years.

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The US Food and Drug Administration has published draft guidance establishing two pathways for medical...