FDA clearances dip in March to lowest rate in 14 months

May 2, 2005

The pace of FDA clearances slowed in March for the second consecutive month and the fourth in a row that the number has failed to break 30.

The pace of FDA clearances slowed in March for the second consecutive month and the fourth in a row that the number has failed to break 30.

The early part of the year typically is slow for the industry. Momentum begins to build in early summer, leading up to a torrent of clearances as the RSNA meeting draws near.

The number of FDA clearances is a direct indicator of how many new products can be expected in the coming weeks or months, as companies gear up their marketing efforts following agency notification. Consequently, few new releases will likely see commercial launches in the near term, considering that March had the lowest number of clearances in since January 2004.

The 21 devices passing FDA review in March were spread over seven categories. Radiation therapy accounted for six. Image management, x-ray, and MR each had three. Ultrasound, nuclear medicine, and CT each had two.

In image management, R2 Technology has created a family of image display units that combine dedicated software and computer hardware. The units display low-resolution nondiagnostic medical images with such annotations as precomputed regions of interest and precomputed CAD marks. The devices use an off-the-shelf PC with a Windows-based CPU, hard drive, and monitor. The monitors vary in physical dimensions but have identical functional specifications. Onboard software provides an updated user interface and CAD marking features.

In MR, Siemens Medical Solutions is grooming a cordless coil to work with its Concerto and C! systems. The cordless device, developed by Rapid Biomedical in Bayern, Germany, consists of one receive coil inductively coupled to another. The coupling loop is connected by cable.

StarShieldV3 from Odin is designed to reduce electromagnetic interference that might compromise the performance of the company's PoleStar intraoperative MR system. StarShield makes use of a portable modular structure called an RF tent.

In nuclear medicine, CTI PET Systems is updating the PET component and patient handling system of its LSO PET/CT Hi-Rez scanners. Some changes reviewed by the FDA are designed to reduce costs or allow modifications that change the look of the gantry. Other changes were incorporated to improve manufacturability and serviceability, as well as to deal with parts obsolescence.

Cardiovascular Imaging Technologies of Kansas City, MO, has created software that allows physicians and healthcare professionals to inspect, reconstruct, and reorient myocardial perfusion PET images. The lmagePRO is installed on desktop computers. It processes perfusion and gated PET raw emission and transmission data to create 3D tomographic reconstructions. The user can select correction parameters, filter settings, range of reconstruction, and reorientation angles.

The FDA has cleared a PET/CT, the Discovery VCT, that GE showed as a work-in-progress at the 2004 RSNA meeting. This latest development is equivalent to the company's current Discovery ST system, except that it integrates a 64-slice LightSpeed CT with the company's high-performance PET scanner.

In CT, Toshiba's Aquilion LB is a large-bore scanner featuring a selectable slice-thickness multirow detector capable of generating up to 32 slices per second. The company showcased the unit, designed to accommodate oncology cases, at the 2004 RSNA meeting as a work-in-progress.

In the x-ray category, Medlink Imaging in Elmsford, NY, has developed a family of digital radiography systems. Uniscan is a stationary general-purpose diagnostic system designed to deliver planar radiographs of bone and soft tissues. It can handle patients standing, sitting, and lying down. Pulmoscan, a variation of this system dedicated to imaging the thorax, is intended for screening applications. Pulmoscan-T is tailored as a mobile system to screen patients at such sites as educational institutions, remote villages, and military units, as well as places with special access requirements such as refugee camps and prisons.

Innova 2100-IQ appears to fit into GE's Innova family of digital fluoroscopy systems. It combines features from Innova 2000/LCV+ Version 2 and Innova 3100 to enable cardiac and vascular procedures. Rotational angiography is optional.