MINNEAPOLIS – In what the IBF Med-Tech Investing conference held here last week billed as a fireside chat – complete with a virtual log fire on two big screens – Don St. Pierre, associate director for policy and operations at the Center for Devices and Radiologic Health's (CDRH) Office of In Vitro Diagnostic Device Evaluation and Safety (OVID), discussed potential heightened barriers to the use of the 510(k), including the need for more scientific data for this regulatory pathway. (Diagnostics & Imaging Week)

MINNEAPOLIS – It is a challenging time to be out looking for funding if you are involved in the medical technology sector, but companies aren't the only ones having trouble raising money. Venture capitalists are also struggling to put together funding rounds in some instances, particularly trying to raise money from gun shy institutional investors who are the lifeblood of their business. (Medical Device Daily)

MINNEAPOLIS – As the 8th edition of the IBF Med-Tech Investing Conference got under way here yesterday, the tone of the talks was generally upbeat, considering the consistently gloomy state of the economy. (Medical Device Daily)

Ardian (Palo Alto, California), a privately held developer of the Symplicity, a catheter-based medical device to treat hypertension, reported receiving one of the largest financing rounds in the medical technology sector in the last six months, with a raise of $47 million. (Medical Device Daily)