Category: Regulatory

ArtVentive inks deal with clinical and regulatory strategy firm

September 2, 2010 by MassDevice staff

ArtVentive Medical Group Inc. (OTC:AVTD) signed an agreement with Northwest Clinical Research Group Inc. to prepare for regulatory processes in the U.S. and abroad.

The deal provides for Woodinvill, Wash.-based NCRG to assist ArtVentive in building its quality systems and securing Food & Drug Administration and European CE Mark approvals.

Quidel gains FDA clearance for pregnancy test

September 1, 2010 by MassDevice staff

Quidel Corp. (NSDQ:QDEL) landed a nod from the Food & Drug Administration for its new pregnancy test platform.

The RapidVue dipstick-format pregnancy immunoassay will be the San Diego-based diagnostics company's fourth product launched this year, according to a press release.

Quidel designed the human chorionic gonadotropin-based test to be used with urine samples. The company said test results are available three minutes after use.

FDA releases July 510(k) clearances

September 1, 2010 by MassDevice staff

The Food & Drug Administration released the pre-market approvals it granted during July:

InfraReDx wins FDA clearance for coronary imaging system

September 1, 2010 by MassDevice staff

The Food & Drug Administration gave InfraReDx Inc. 510(k) clearance for the company's LipiScan IVUS coronary imaging system.

The device employs both so-called "near-infrared" spectroscopy and intravascular ultrasound technology to give cardiologists a grayscale IVUS image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.

FDA begins measuring its own performance, transparency

August 31, 2010 by MassDevice staff

The Food & Drug Administration today launched a rating system for its organizational performance.

The federal watchdog agency's new system, "FDA-TRACK," is designed to meet President Barack Obama's attempts to make the U.S. government more transparent and collaborative, with more public participation. The acronym stands for transparency, results, accountability, credibility and knowledge-sharing.

Precocious Hotspur through regulatory hurdles with "minimum" cash

August 31, 2010 by MassDevice staff

Two-year-old Hotspur Technologies Inc. landed three Food & Drug Administration clearances in less than four months, all with the relatively modest backing of $5.5 million.

The Mountain View, Calif.-based company, which was incorporated in 2008, claimed its first three 510(k)s, one in 90 days and two more in 110 days.

Medtronic wins CE Mark for new drug-eluting stent system

August 30, 2010 by MassDevice staff

Medtronic Inc. (NYSE:MDT) won CE Mark approval in the European Union for its new drug-eluting coronary stent system.

The Minneapolis-based medical device giant said the device's new design gives it superior mobility within a patient’s vasculature.

Medtronic said the stent's new "continuous sinusoid technology" gives the device significantly more deliverability than alternative stents when administered with the its MicroTrac delivery system.