FDA clearances surge in October, keep industry in line for new record

November 22, 2004

The industry jumped back on track in October, clearing 36 new devices compared with 25 the month before. October’s pace was slower than the same month a year earlier, when 42 radiological devices passed review. But for 2004, vendors stayed slightly ahead of the previous -- record --year: 283 to 277.

The industry jumped back on track in October, clearing 36 new devices compared with 25 the month before. October's pace was slower than the same month a year earlier, when 42 radiological devices passed review. But for 2004, vendors stayed slightly ahead of the previous - record -year: 283 to 277.

The only MR clearance, a scanner from Esaote, will put a new twist on open scanning. G-Scan, which images the extremities and spinal column, is equipped with a hydraulic mechanism that rotates both the magnet and the patient table from a horizontal to a vertical position. The patient may be scanned while either lying down or standing in the weight-bearing state, as G-Scan changes between its two "C" faces. The 0.24T system has a gantry opening of 33 cm and weights just over 8000 kg.

Among the 12 x-ray clearances was an infant whole-body software option for Hologic's QDR x-ray bone densitometers. The data acquisition and analysis method performs the same functions as the currently commercialized whole-body software option for adults, which estimates bone mineral content, bone mineral density, and body composition (lean body mass and fat mass of nonosseous tissues). It adds, however, optional scan types to the QDR XP Scan Module and XP Analysis Module of the QDR for infants from birth to one year. The option was created by modifying the data acquisition module to enable a smaller region of interest, thinner x-ray beam, and slower scan speed to improve spatial resolution and bone edge detection. The modification includes an algorithm that employs lower bone and soft-tissue detection thresholds suitable for evaluating the low bone densities and low soft-tissue masses found in human infants.

Analogic is cleared to market a new flat-panel detector. The GR17 is an amorphous selenium-based digital radiography detector, designed to replace radiographic screen-film systems in general-purpose diagnostic procedures. A subsidiary of Analogic, Anexa, is developing a family of high-performance digital imaging products. On Nov. 3, the company announced a multisystem DR order from Vanderbilt University Medical Center of Nashville, TN.

Siemens' Arcadis Ordic is a mobile x-ray system consisting of a mobile C-arm configured with a high-frequency generator, x-ray tube assembly, image intensifier, CCD camera, laser target devices, electronics cabinet, monitor trolley, and digital image storage system. The mobile C-arm is designed to provide fluoroscopic and digital spot-film imaging of the patient during surgical and interventional procedures. Clinical applications may include cholangiography and endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. A 3D option is particularly suited to intraoperative visualization of high-contrast objects and anatomic structures. A 3D Navigation Interface option provides visual support for planning and positioning surgical instruments.

Philips' Practix Convenio is a motor-driven, battery-supplied mobile x-ray unit. It contains a battery cluster including battery charger, two passive and two motor-driven wheels, 20-kHz converter x-ray generator, a 360° turning column, and a telescoping arm that carries the x-ray unit. Also included are an antiscatter grid and a drawer for x-ray film cassettes.

Siemens' DynaCT promises to pull CT and rotational angio closer together. The imaging software option allows the reconstruction of 2D data acquired with a standard angiographic C-arm device into a 3D format. It is intended for diagnosis, surgical planning, interventional procedures, and treatment follow-up.

One of the two radiotherapy products to pass the FDA in October was a computed radiography product designed to allow portal imaging over a wide dose range from 1 MU (monitor units) to and beyond 400 MU, according to Agfa. To achieve this range, the company has developed two different cassette types. Each is optimized for image quality at its intended dose range, thereby supporting high-dose applications performed during radiotherapy as well as low-dose imaging during simulation, when images are compared with reference scans.

Topping the four nuclear medicine clearances was CTI Molecular Imaging's LSO PET/CT Hi-Rez 64 system, which combines the company's premium performance Accel Hi-Rez LSO PET scanner with 64-slice CT from Siemens. The system is designed for whole-body oncology, neurology, and cardiology examinations.

Of the six ultrasound clearances, the SonoScape Ultrasound System was the only new stand-alone product. Developed by SonoScape of Shenzhen, China, the 64-channel digital scanner can be configured either as a portable (SSI-1000) or cart-based (SSI-5000) system. It supports abdominal, pediatric, small-organ, heart soft-tissue, peripheral vascular, musculoskeletal, and urological examinations, using B-Mode (including tissue harmonic image) and M-Mode and color flow, pulsed, and power Doppler.

Two PACS stood out among the 11 image management products that cleared the FDA in October. The iPACS CARDIO from RealTimeImage combines with the company's iPACS PRISM, which displays and manages stationary and cine images. The new software product is designed to assist cardiac surgeons doing preoperative planning and postoperative follow-up.

GE's integrated Centricity Radiology RA600, Cardiology CA1000, and Digital Hardcopy Workstation provides scalable image and data management solutions that span radiology and cardiology. The RA600 and CA1000 serve as image repositories for the Centricity Web Viewer application. The Digital Hardcopy product is intended as a workstation for the high-volume burning of CDs or DVDs containing DICOM medical images and reports. CD/DVD burning and disk labeling are done via a commercially available external robotic device. The integrated RA600/CA1000/Digital Hardcopy system receives imaging studies and data over LAN, WAN, intranet, or Internet from a PACS server, image archive, or DICOM-compliant modality. The system can also interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It can be sold as software only or as a turnkey system.