FDA clears 27 imaging devices to keep year on record pace

November 12, 2003

Major systems appear in MR and radiotherapySeptember is usually a good month for vendors in the number of radiological devices clearing the FDA. This year it was better than usual. FDA reviewers cleared 27 such devices, a better

Major systems appear in MR and radiotherapy

September is usually a good month for vendors in the number of radiological devices clearing the FDA. This year it was better than usual. FDA reviewers cleared 27 such devices, a better performance than in any September going back to 2000.

The number of clearances is significant because the industry is now ahead of the pace set in 2000, the last time the agency cleared more than 300 radiology products in a year.

Image management accounted for eight clearances. MR and radiotherapy had seven each. Ultrasound had three. X-ray had two. The FDA cleared no CT devices for the second straight month.

Philips Medical Systems was cleared to introduce the successor to its Gyroscan Intera MR family. The new product, dubbed Intera-Sensation Family Release 1-series, consists of configurations at 1T, 1.5T, and 3T field strengths. Intera-Sensation is based on the same platform as its predecessor, but there are differences. One is cosmetic-a new appearance created by novel covers. Others are:

- a data acquisition system that supports one, four, six, eight, and 16 channels, which can be upgraded in the future to 32;

- advanced shimming;

- a more powerful gradient, called Super Quasar;

- added functionality, including ExamCards, MobiFlex, MobiView, Q-Flow, Real Time Bold Imaging, Re-scan, and CareTrak; and

- enhanced data storage capacity.

Odin Medical Technologies is cleared to release an advanced version of its intraoperative MR scanner. This one, called PoleStar N-20, utilizes a permanent magnet to acquire 2D single-slice, multislice, and 3D volumetric images. The new system, which can be used to image the head and extremities, is mobile, whereas its predecessor, the N-10, was not. PoleStar N-20 can be moved within the room between procedures or completely out of the way, from the operating table to its "magnet storage cabinet," thus allowing the operating room to be used for any type of surgery.

Hitachi Medical Systems America obtained clearance to market an enhanced version of its flagship open MR scanner. The new system, called Airis Elite, provides increased clinical utility compared with its predecessor, Airis II. Diagnostic applications include:

- 2D/3D T1- and T2-weighted imaging;

- T1, T2 proton density measurements;

- diffusion-weighted imaging;

- MR angiography; and

- image processing.

Aurora Imaging Technology of North Andover, MA, is now cleared to sell in the U.S. a version of its Aurora breast imaging system with a fat-suppression pulse sequence, called RODEO. The Rotating Delivery of Excitation Off-resonance breast imaging method provides robust fat-suppression, magnetization transfer contrast. Fat-suppression helps reduce the high-intensity fat signal that usually accompanies MR mammography, thereby maximizing contrast in enhancing tumors. Magnetization transfer contrast is used to reduce signal from normal ductal tissue and avoid false-positive enhancement from benign lesions.

Three of the MR devices cleared in September were coils. Two were 3T eight-channel coils, one for neurovascular imaging, the other for imaging the cervical, thoracic, and lumbar regions of the spine. Both were developed by USA Instruments, a subsidiary of GE Medical Systems.

Image management included two PACS, one by Telemis of Belgium, the other by Rattan Information of Taiwan. The Telemis-Medical Solution was developed with Java technology that allows the software to run on any operating system that implements a Java virtual machine environment, including Windows, MACOS, and Unix. Rattan IMACS is designed for deployment over conventional network infrastructure and utilizes Intel Pentium-based computer platforms and Windows operating systems.

In radiotherapy, Accuray of Sunnyvale, CA, got the go-ahead for a stereotactic radiosurgery tool called CyberKnife. The computer-controlled system helps plan and perform minimally invasive radiotherapy using a linear accelerator, robotic manipulator, and target locating subsystem. CyberKnife tracks implanted fiducials, dynamically positioning and pointing the linear accelerator at pathologies anywhere in the body.

Siemens received clearance for its Oncor Avant-Garde, an enhanced version of the Primus design architecture that also includes an amorphous silicon flat-panel portal for imaging the targeted area. The portal, called Optivue, aids in verifying patient position markers and anatomic references. Also included is an 82-leaf collimator, called Optifocus, and Therapist Workspace software. Optifocus is based on the same architecture as the previously cleared 58-leaf version. The software provides an interface for 2D or volumetric targeting.

In the x-ray category, Siemens' Siremobil Iso-C 3D stood out. The mobile C-arm system, which has been on the market for two years, was cleared for extended indications that allow complete imaging of the spine (SCAN 10/29/03).

Simuplan, a treatment planning system by a company of the same name in Valencia, Spain, passed FDA muster. Simuplan maps out treatment with external beam or brachytherapy.

Exomio by MedCom of Darmstadt, Germany, is a patient simulator for planning radiotherapy. The virtual simulation is created using CT data, allowing the relation between treatment beams and tumor to be investigated in detail. Using DICOM, parameters can be exported to other devices for the actual therapy planning. Capabilities include contouring and segmentation, radiation treatment field editing, and 3D visualization of the virtual treatment setup.