FDA clearances surge in August to highest point of the year

October 10, 2005

The surge in FDA clearances that typically occurs in the months preceding the RSNA meeting may have gotten off to an early start. Manufacturers earned clearances for 35 devices from the FDA in August, the highest total of the year and at least a 50% jump over the months from March through July.

The surge in FDA clearances that typically occurs in the months preceding the RSNA meeting may have gotten off to an early start. Manufacturers earned clearances for 35 devices from the FDA in August, the highest total of the year and at least a 50% jump over the months from March through July.

Devices in image management and ultrasound led the pack with 11 and eight clearances, respectively. They were followed by x-ray with seven, MR with five, and radiotherapy with two. Nuclear medicine and CT brought up the rear with one apiece.

Inflating the overall numbers were a few dental devices, one in x-ray, the other in image management. The group also included some oddballs: a disinfectant and a cover for ultrasound transducers.

Among the notables was a high-performance dual-head SPECT camera from the Haifa headquarters for GE Healthcare. The new Ventri is designed for cardiac imaging but could be used as a general-purpose system. The extrawide gantry composed of lightweight materials features computer-controlled radial motion that supports noncircular SPECT orbiting for high-resolution scans. The detectors each contain 22 3-inch and six 1.5-inch photomultiplier tubes.

In x-ray, GE Healthcare has upgraded its Revolution XR/d with tomosynthesis. The company emphasized that the hardware and software option is not intended for mammographic use. OrthoScan of Scottsdale, AZ, has developed a mobile mini-C-arm imaging system, which is named for the company. The OrthoScan C-arm includes an articulating arm and a workstation.

Philips is cleared to market 1.5T successors to its Achieva and Intera lines featuring gradients that support increased slew rates. These will allow shorter echo times, echo spacing, and repetition times.

MR coils, always a popular segment among newly cleared devices, accounted for several in August. Two stand out for allowing new clinical capabilities for their associated MR scanners.

Esaote's cervical spine coil will substantially extend the clinical reach of the company's G-scan system, which features a tilting table that takes the patient from supine to standing. The solenoidal linear receive coil is shaped to match the cervical vertebrae. The scanner is optimized for musculoskeletal applications. Since its unveiling at the RSNA meeting last year, G-scan has been marketed only in Europe.

Confirma's seven-channel, phased-array breast coil serves both diagnostic and interventional purposes. The coil, which is compatible with Siemens 1.5T MRI systems, is optimized for parallel imaging of the chest wall, breast, and axillary tissue. It supports interventional procedures with lateral, medial, and craniocaudal access. Positioning accessories, including a headrest, armrest, and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of breast MRI studies and interventional procedures.