• Advanced Magnetics (Cambridge, Massachusetts) reported that it has received an "approvable" letter from the FDA regarding Combidex, its investigational functional molecular imaging agent. The FDA requested additional data to demonstrate the efficacy of Combidex, and suggested that the data be limited to a well-defined population of specific cancer types. The agency indicated that its principal issues relate to the topics addressed by the Onocologic Drugs Advisory Committee on March 3, primarily how the data submitted by the company could be generalized across all tumor types. "We intend to continue our active dialogue with the FDA to determine the necessary next steps to achieve approval for Combidex," said Jerome Goldstein, chairman, president and CEO of Advanced Magnetics. "Until we establish the nature of what the FDA believes will be acceptable additional data, we cannot speculate on what we may have to do to address the FDA's concerns or how long the process will take."

• Medtronic (Minneapolis) reported the recent introduction of the Attain Select 6238 TEL Guide Catheter Set that aids in the safe and effective implantation of device leads in the veins that serve the left side of the heart for the treatment of heart failure. The Attain Select products, now available in the U.S., Europe and Canada, are highly specialized to give physicians a range of choices as they work from outside the body to select the most appropriate cardiac veins leading to the heart's lower left chamber and safely maneuver an insulated lead through them to carry electrical impulses from an implanted cardiac resynchronization therapy device. The set includes catheters in three shapes: one shaped with its tip in a 90-degree curve and another with a 180-degree curve; and a straight catheter to aid in cannulation of the coronary sinus or in crossing partially blocked or narrowed veins. The catheters of the new set offer stiffness, the ability to deliver contrast media, and clear fluoroscopic trackability. Their softer tips are designed to reduce risk of trauma to blood vessels and their smaller inner lumens (0.040" diameter) provide precise tracking over any guidewire with up to a 0.035" diameter. The Attain Select catheters are designed to fit inside current Medtronic Attain catheters that are used for coronary sinus cannulation.

• Planar Systems (Beaverton, Oregon) reported the release of Dome Dashboard, a software console application that simplifies the centralized management, monitoring and control of medical imaging displays for administrators of picture archiving and communications systems. In conjunction with Dome CXtra software, the monitoring and calibration software included with all Dome medical imaging display systems, administrators use Dome Dashboard to set up alerts for immediate pages when a display changes in any unexpected way.

• Siemens Medical Solutions (Malvern, Pennsylvania) reported that its 550 TxT Treatment Table has received 510(k) clearance from the FDA, and is now commercially available in the U.S. The system's design improves patient positioning capabilities to new standards, while providing the mechanical strength that allows for a load capacity of 550 pounds. A number of enhanced features are available to meet the ongoing changes in radiation therapy treatment techniques and protocols, including: a choice of different carbon fiber table tops; all motorized movements with ramp-up speed functionality; ergonomic design features; and hand controls at the table with an integrated flashlight to assist with correct patient positioning in the darkened treatment room. The 550 TxT table was designed and manufactured in conjunction with the Components Division (Kemnath, Germany) of Siemens Medical Solutions.