FDA clearances rebound to end year at high point

February 6, 2002

Major developments mark late surge FDA reviewers cleared MR, PACS, x-ray, and ultrasound devices in December that could turn into major products for vendors in the months ahead. The clearances were part of a flurry of regulatory

Major developments mark late surge

FDA reviewers cleared MR, PACS, x-ray, and ultrasound devices in December that could turn into major products for vendors in the months ahead. The clearances were part of a flurry of regulatory activity, as the agency pushed 30 units through its pipeline in the waning days of 2001. The number of clearances was the most at any time during the year, surpassing the 29 clearances achieved in February and August and breaking the trend of mid- and low-20s numbers that began in September.

The December surge put a positive twist on a year that fell far short of the preceding one, as the industry achieved 7% fewer clearances in 2001. Throughout much of the year, the number of each different type of product cleared by the FDA had been remarkably consistent, as no single class of technology has overshadowed any other. This trend continued in December as MR, PACS, x-ray, and radiotherapy each scored six clearances. Ultrasound had four. CT had only two and these were modest: a calcium scoring product and a bone densitometry package. Conspicuously absent were products representing nuclear medicine.

Three of the six MR products were coils. Another was an upgrade by Odin Medical Technologies of the company's neurosurgical MR scanner, PoleStar N-10. The software enhancement, which was cleared Dec. 17, includes an image-guidance feature that allows the surgeon to mark clinically relevant structures as an aid to planning a surgical trajectory to the target. Guidance adjusts to compensate for brain shift, identified through intraoperative scans.

The other two clearances were among the most significant radiological devices to pass FDA review in December. Siemens' Magnetom Trio, a whole-body 3T scanner, passed muster Dec. 28. The product joins GE's Signa VH/i as the only such products cleared for sale in the U.S. Siemens had previously cleared and has been marketing its Allegra 3T unit, which is dedicated to neurological studies. Trio promises to attract a much wider customer base by allowing cardiac imaging as well.

Philips Intera I/T cleared the FDA on Dec. 11. The system, which is dedicated to interventional applications, is built around the company's Intera 1.5T system. The tabletop supports patient transfer from outside "workspots" utilizing other modalities, such as an x-ray angiography system, to the MR. These workspots are located outside the 0.5mT- fringe field of the Intera I/T. The system will be offered in three versions. The standard configuration supports interventional procedures not requiring modalities other than MR. The other two support patient transfer to outside workspots to allow head and neck interventions (neurosurgical version) and cardiovascular interventions (CV version).

Ultrasound's four clearances included transducers, a transducer cover, and an intraoperative probe. The standout in this category was a portable unit described by SonoSite as being equivalent to its handheld products (SonoSite 180PLUS and the SonoHeart PLUS) and the HDI 5000, ATL's flagship product (ATL spun-off SonoSite about four years ago as a publicly held company.) If the new product, which cleared the FDA Dec. 20, lives up to its billing, it will mark the first truly high end handheld unit to enter the market and might provide SonoSite the opportunity to compete for high-price, high-margin sales. The unit could be positioned in either the radiological or echocardiographic market. Notably, among the capabilities listed in the FDA documents is ECG monitoring as well as advanced features for assessing the heart and coronary vessels.

Among the categories receiving most of the FDA's attention, radiotherapy was the weakest. This category was populated by therapy-planning hardware and software, a table accessory, a beam attenuator, and two brachytherapy products—a radionuclide source and a needle-based seed dispenser. X-ray was not much stronger. Four of the six products were dental systems. One of the two others was a storage phosphor cassette from Kodak, called the DirectView Tabletop CR cassette. The remaining product, however, is notable for the type of system and the technology built into it.

Speed Suite by Fujifilm Medical Systems USA supports the digital capture of x-ray data regarding the entire body from skull to extremities. The system, which was cleared Dec. 6, combines a Fuji CR reader and workstation with several x-ray components made by Siemens, namely an x-ray tube, generator, automatic collimator, tube stand, bucky table, and bucky wall stand. Making all these pieces work together is Fuji's X-CON software, which allows the CR reader to interface with Siemens' x-ray equipment. Communications are further enhanced by software built into the workstation and a data acquisition terminal. This software integrates existing patient anatomical menus, which minimize x-ray dosage to the patient by prescribing specific doses for selected patient exams. These parameters are displayed to the user onscreen. Exposure defaults can be adjusted according to user preferences.

Along with the usual mix of reading station, archiving, and transmission technologies, the December PACS clearances included a standout: eNTEGRA PE. The product, cleared Dec. 21, was described by GE Medical Systems as a diagnostic imaging personal digital assistant. It is the industry's first handheld computer capable of displaying, processing, archiving, and communicating medical images. The review station, designed specifically for nuclear medicine, including PET, works with other members of the eNTEGRA family of workstations via native TCP/IP communications protocol. It can also serve as a stand-alone client/server (SCU/SCP) DICOM engine to communicate with all other DICOM-compliant workstations and PACS/RIS systems. Bidirectional communications are supported via wired and wireless Ethernet, modems, infrared, and serial USB channels. For patient data archiving, eNTEGRA PE is equipped with 5 GB storage. Additionally, eNTEGRA PE has three layers of security features composed of 128-bit encryption, user authentication, and application-level encryption.