FDA clearances boom in May and June to near record levels

June 28, 2004

The spring crop of FDA clearances was remarkable as much for its number as for the quality and sophistication of the devices that passed review. In two months, the agency cleared 62 devices: 36 in April and 26 in May. The clearances comprised several

The spring crop of FDA clearances was remarkable as much for its number as for the quality and sophistication of the devices that passed review. In two months, the agency cleared 62 devices: 36 in April and 26 in May. The clearances comprised several major systems, such as Siemens' and Philips' SPECT/CT systems, which were unveiled at the Society of Nuclear Medicine conference in June (see top cover story).

April and May marked high points for the year in the sheer number of approvals, as clearances in both months eclipsed the 12 in January, 23 in February, and 24 in March. The 36 OKs in April were the most for any month, except one, going back to January 2000. The exception was October 2002, when the agency cleared 40 devices.

These passes were spread evenly over all categories in May with five clearances each in image management and x-ray edging out the four in nuclear medicine and three each in CT, MR, and radiotherapy. Ultrasound trailed that month with one. A dental system and a bone densitometry product filled out the clearances.

April was less balanced, as image management took the lead with 12 clearances followed by radiotherapy with eight. Bringing up the rear were x-ray and MR with four each, ultrasound with three, CT with two, and nuclear medicine with one. Two dental offerings filled out the month.

Philips cleared its SPECT/CT scanner on May 24 under the name Griffin using the old company name ADAC Laboratories. The system, released at the SNM under the product name Precedence, was described to the FDA as allowing the registration of nuclear medicine and CT images, which can then be displayed as a fused set. It can be used as a separate single-photon system, a separate CT system, or as a combined CT and SPECT system.

One week earlier, the FDA cleared Siemens' "Enhanced Imaging System," described as an improved version of the e.cam gamma camera that incorporates a CT. In much the same manner as Philips, Siemens noted that the new product could be used to perform SPECT and CT separately, as well as SPECT/CT.

Philips also gained clearance for its Syntegra, a software application for multimodality image registration and diagnostic fusion. Images are registered and overlaid to provide combined functional and anatomical data from different angles. Syntegra is designed for use with the company's Gemini 16 PET/CT, which incorporates a 16-slice CT scanner. Syntegra images can be presented using various volumetric rendering techniques, such as multiplanar reformatting, surface rendering with cut planes, and maximum-intensity projections. It also offers region-of-interest tools, which allow the user to draw 2D contours around areas of interest on the transaxial plane images. The contours can then be exported to radiation therapy planning systems, which use the 2D contours to generate 3D volumes for therapy planning.

Acrorad of Okinawa, Japan, has developed a miniature gamma camera, the MGC500, for use during intraoperative procedures. Rather than using a sodium iodide scintillating crystal and photomultiplier tubes, the MGC-500 incorporates a solid-state detector made from the semiconductor cadmium telluride.

In MR, Esaote modified its Artoscan C, upgrading the electronics, adding new pulse sequences, enhancing the software, and creating a new mobile configuration. Israel-based Robin Medical developed EndoScout, which tracks in real-time the location and orientation of interventional devices during MR-guided procedures. Devices and tools that might be tracked include biopsy needles; radio-frequency ablation, laser ablation, or cryotherapy probes; devices used to deliver therapeutic agents such as drugs, genetic vectors, or stem cells; as well as various support tools such as suction tips and pointers.

In CT, Hitachi's Presto multislice system passed FDA review. The system collects up to four slices of data simultaneously. Images are displayed on a computer workstation, where they are also stored, printed, and archived. The workstation is based on PC technology using the Windows operating system.

GE developed CT Colonography II, an image analysis software package that allows the visualization of 2D and 3D medical images of the colon derived from DICOM 3.0-compliant scans. The software package is designed to screen the colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D, and 360 degrees dissection views, and an object-oriented endoluminal display.

Aperio Services of Sarasota, FL, developed the NewTom 3G, a radiology-to-dentistry crossover technology. The system acquires then reconstructs CT data into a 3D matrix. It can present the data as 3D or 2D images, as well as measure distances and thicknesses on these images. It is intended primarily for planning and monitoring of implantations, and in the field of maxillofacial surgery.

Notable in image management is Agfa's new orthopedic workstation. This workstation utilizes software optimized for planning orthopedic surgeries. Along with basic diagnostic display station functionality, it reads digital radiographs and applies them to a database of orthopedic implant geometries and dimensions. The proper choice of prosthesis implant, size, and placement will determine postoperative success and minimize intra-operative complications. The workstation provides orthopedic surgeons with the information needed for presurgical planning. It supports comparisons of pre- and postoperative radiography studies in the context of information derived from the patient's physical exam.

In radiotherapy, Brainlab AG's ExacTrac 4.0 places patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The system, which will also be marketed under the name ExacTrac X-ray 6D, uses optical tracking of infrared reflecting markers and x-ray registration to determine the correct position of the patient. CT images are compared to real-time x-ray images. Structures used as reference points can be either anatomical landmarks or implanted internal markers. In some cases, such as positioning for the treatment of prostate tumors, ultrasound may be used instead of x-ray fluoroscopy.

In x-ray, Paieon of New York City passed FDA review with its CardiOp-B, image acquisition and processing software designed as an add-on to conventional single-plane x-ray angiography systems. It assists in the evaluation of coronary lesions by creating 3D images of coronary vessel segments based on 2D angiography images. CardiOp-B also calculates dimensions of arterial segments based on the 3D image. It is intended for use in real-time in the catheterization lab and offline for postprocedural analysis.

GE gained clearance for its Senographe Stereo, an option for obtaining stereotactic biopsies using the Senographe DS full-field digital system. A pair of images is taken with the tube arm angled to +150 degrees and -15 degrees with respect to the image receptor. It is composed of a stereotactic positioner, display and stereo positioning software, a lateral arm, and a vertical adapter for use with a vacuum-assisted device.

The stereotactic positioner slides onto the image receptor of the Senographe DS. Two connectors in the back of this device plug into the image receptor connectors. One energizes the stereotactic positioner. The second plugs the stereotactic positioner into the gantry, allowing communication with the rest of the system.

The positioner performs several functions, among them compressing the breast and getting the coordinates of the target area from the acquisition workstation. The software comprises a stereotactic viewer on the acquisition workstation, exposure mode management, and code that allows stereotactic motion control and interlocks to ensure safety. The lateral arm allows the user to access the lesion from both sides of the stereotactic positioner. The vertical adapter is a mechanical accessory used to install a vacuum-assisted device such as a Mammotome, manufactured by Ethicon Endo Surgery.

Mobilsonic of San Jose, CA, is cleared to market its VUE 100 Ultrasound Imaging System. The portable ultrasound product can acquire and display real-time 2D images using either of two mechanical sector probes, one operating at 3MHz, the other at 5MHz. It is designed for general-purpose, noninvasive, diagnostic ultrasound imaging studies, including abdominal, peripheral vascular, fetal, and small organ applications.