Philips compact MRI receives FDA go-ahead

December 29, 1993

Philips Medical Systems received Food and Drug Administrationmarketing clearance last week for its 0.5-tesla and 1.5-teslaGyroscan NT MRI systems introduced at the Radiological Societyof North America meeting earlier this month. Both systems

Philips Medical Systems received Food and Drug Administrationmarketing clearance last week for its 0.5-tesla and 1.5-teslaGyroscan NT MRI systems introduced at the Radiological Societyof North America meeting earlier this month. Both systems providecompact magnets with flared bores for easy access in interventionalapplications.

Gyroscan ACS-NT uses the same magnet design as Philips' mid-fieldGyroscan T5--developed in cooperation with Intermagnetics General--andcan be sited in about the same amount of space. The bore is 60cm wide at the central body coil but flares to 100 cm at bothends. Only one or two helium refills per year are required, accordingto Chris Farr, MRI marketing director.

The mid-field NT system is an evolutionary upgrade from thevendor's T5 scanner. Gyroscan ACS-NT, however, marks Philips'long-planned transference of T5 technology to the high-field topof its line, he said.

Gyroscan NT systems offer echo-planar imaging and GRASE fastscanning. Both units are capable of high resolution, 1024 x 1024-pixelacquisition, reconstruction, display and archiving, Farr said.

The new magnet cuts the length of Philips' high-field offeringin half, to 180 cm. Existing ACS scanners can be upgraded to theNT platform, but with double the bore length of new ACS-NT systems.

Gyroscan ACS-NT weighs the same as the mid-field NT, about8000 pounds when fully loaded with cryogens. Hospital structuralrenovations are not required for siting as in the past. The ACS-NTcan fit in a freight elevator, Farr said.

Changes in magnet design allow Philips to overcome past sitingdisadvantages at high field, he said.

"The biggest hurdle Philips had in increasing market shareat 1.5-tesla was siting costs," Farr told SCAN. "Wewere one of the most expensive magnets to site. The magnet waslarge and heavy and required a lot of room."

The technologist or interventionalist can tend to the patientat either end of the magnet. Imaging/monitoring consoles are placedon both ends of the magnet directly above the bed. Improved accessand an MR fluoroscopy copy feature provide interventional benefitsto the system, Farr said. MR fluoroscopy can acquire, reconstructand display 10 images per second.

The short bore enables additional applications, such as cardiacstress testing. Philips offers a bicycle ergometer that can beoperated by the patient while the top half of the body is beingscanned. The stress system varies pressure to maintain a desiredheartbeat.

BRIEFLY NOTED:

  • Picker received Food and Drug Administration market clearancefor its three new MRI scanners, 1.5-tesla Edge, 1-tesla Vistaand 0.5-tesla Asset, shortly before the RSNA conference this month,according to Linda Eastwood, high-field product manager.

Vista was Picker's RSNA highlight in MRI. The new 1-tesla systemruns on the same platform as the Edge and Asset scanners, introducedlast year. Vista offers 16 millitesla-per-meter gradient strengthand the same fast ramp rate of the Edge, Eastwood said. The unitcan be sited in 435 square feet of space and requires only twocryogen fills a year.

  • Philips Medical Systems received long-awaited FDA marketingclearance this month for CVI-Q, its non-Doppler ultrasound blood-quantificationproduct (SCAN 6/30/93). Philips filed a 510(k) application forCVI-Q over a year ago and initially expected to have the productavailable in the third quarter of 1992. The technology's applicationwas slowed by FDA requests for additional data on the product.

CVI-Q will be available as an option for purchasers of Philips'P700 SE scanner and as an upgrade for P700 SE units in the field.A CVI-Q upgrade will cost $25,000, according to the company. Philipswill begin shipping CVI-Q in January.

  • Bennett X-ray has received a patent from the U.S. PatentOffice for its Contour mammography system, which features a tiltingC-arm to enable the system to image more breast, according tothe company. At the RSNA meeting, Bennett displayed the resultsof a clinical study in which the system imaged 1 to 2 cm of additionalbreast tissue in 83% of patients studied.

Bennett, of Copiague, NY, also displayed several new optionsfor Contour at the RSNA meeting, including a Cytoguide breastbiopsy device, a work-in-progress digital spot mammography unitand a recumbent breast biopsy table.

Bennett has experienced strong sales of Contour in the yearsince the system was introduced, according to CEO Calvin Kleinman.The system has an installed base of about 200, Kleinman said.

  • Acoustic Imaging introduced Performa, a new low-cost ultrasoundsystem, at the RSNA meeting. The system is upgradable to spectralDoppler and supports specialty software for general radiology,as well as ob/gyn and breast imaging. The Phoenix company plansto market the system to both hospitals and private practices.AI also announced Envision, an upgrade to its flagship AI 5200S scanner. AI 5200 S Envision features design changes to the 2-Dand color Doppler scan converters to improve image quality, accordingto the company.

  • ATL launched its Access digital distribution system atthe RSNA show. The digital-optical storage capability, introducedearlier in 1993 as an option on the Ultramark 9 HDI, is the basisfor ATL's approach to data management. The Access 200 workstationand network imager manager were new.

ATL demonstrated interconnectivity with 3M, Camtronics, Agfa,Polaroid, Kodak and Du Pont printers. The Access workstation isa 486-chip, 66-MHz platform that performs on an IBM OS/2 operatingsystem and proprietary hardware and software.

  • Bristol-Myers Squibb has acquired worldwide rights tomanufacture and market LumenHance (manganese chloride), an oralMRI contrast agent for gastrointestinal imaging. LumenHance wasdeveloped by ImaRx Pharmaceutical of Tucson. Squibb submittedan investigational new drug (IND) application for LumenHance inDecember 1992.

The agreement is the second between the two companies. Earlierthis year Squibb acquired U.S. rights to SonoRx, an oral ultrasoundcontrast agent, from ImaRx (SCAN 3/10/93). Squibb subsequentlyacquired worldwide rights to the agent.

  • PACS software developer Cemax of Fremont, CA, has receivedFDA 510(k) marketing clearance for its VIP 1.4 Image Server productline. The product is a Unix-based object-oriented database serverfor image review, storage, retrieval and distribution.

The agency's timing was fortuitous for Cemax, coming on thesecond day of the RSNA meeting. The system is designed in a fullydistributed client/server architecture, which allows data storageand access in different locations in a hospital, rather than atone centralized archive.