Regulatory: Page 223

Cook receives FDA nod for Zenith stent trial
By AuntMinnie.com staff writers
Interventional device firm Cook Medical said it has received U.S. Food and Drug Administration (FDA) clearance to begin a phase I clinical trial for the evaluation of its Zenith Dissection endovascular stent system.
September 23, 2007
IDSI sells HQ for $4.4 million in leaseback deal
By AuntMinnie.com staff writers
Imaging Diagnostic Systems (IDSI) of Plantation, FL, has sold its headquarters building for $4.4 million in cash pursuant to a sale/leaseback agreement.
September 18, 2007
MR experts take issue with FDA gadolinium warning
By Shalmali Pal
In May 2007, the U.S. Food and Drug Administration (FDA) recommend that a "black box" warning label be places on all gadolinium-based contrast agents. Now a group of MR safety experts have deemed the FDA's suggestion as "imprudent." They argue that the risk of a patient with renal disease developing nephrogenic systemic fibrosis (NSF) does not currently appear to be the same among the various gadolinium-based MR contrast agents.
September 17, 2007
Virtual Imaging wins FDA clearance for FluoroPro
By AuntMinnie.com staff writers
Virtual Imaging of Deerfield Beach, FL, has received clearance from the U.S. Food and Drug Administration (FDA) for its new high-resolution digital acquisition system, FluoroPro.
September 13, 2007
Accuray nets FDA nod for dose calculation tool
By AuntMinnie.com staff writers
Radiotherapy firm Accuray said that its Monte Carlo dose calculation algorithm has received U.S. Food and Drug Administration (FDA) 510(k) clearance.
September 10, 2007
Medtronic launches CareLink in Europe
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received CE Mark approval for its CareLink Network with Conexus Wireless Telemetry, and the company plans to debut the device in the European Union.
August 29, 2007
FDA clears Calgary Scientific cardiac software
By AuntMinnie.com staff writers
Advanced visualization software developer Calgary Scientific of Alberta, Calgary, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ResolutionMD Cardiac software.
August 23, 2007
BSD Medical clears first PMA hurtle
By AuntMinnie.com staff writers
Brachytherapy and hyperthermia therapy developer BSD Medical of Salt Lake City met a milestone in its premarket approval (PMA) application process with the U.S. Food and Drug Administration (FDA).
August 22, 2007
FDA clears GE FFDM unit for mobile use
By AuntMinnie.com staff writers
GE Healthcare of Chalfont St. Giles, U.K., has received U.S. Food and Drug Administration (FDA) clearance to market its Senographe Essential full-field digital mammography (FFDM) system for mobile use.
August 21, 2007
Varian gets FDA nod for planning tool
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Smart Segmentation tool.
August 20, 2007
CardioDynamics outlines Nasdaq compliance options
By AuntMinnie.com staff writers
Impedance cardiography (ICG) developer CardioDynamics of San Diego has updated its plans for bringing the company back into compliance with the Nasdaq stock exchange's listing requirements.
August 8, 2007
FDA clears Deep Breeze lung imaging unit
By AuntMinnie.com staff writers
Israeli imaging startup Deep Breeze announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the company's VRIXP system, a noninvasive, radiation-free pulmonary imaging system that uses sounds to create dynamic images of the lungs.
August 8, 2007
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