GE wins FDA clearance for Logiq 700, chases ultrasound market share

Vendor also to market mid-tier Logiq 500 in U.S.

GE Medical Systems received Food and Drug Administration 510(k)marketing clearance for its Logiq 700 ultrasound scanner lastmonth. Milwaukee-based GE now embarks on what is sure to be anarduous fight to wrest market share from more established playersin the ultrasound industry.

The FDA's timing on Logiq 700 couldn't have been more fortuitous.Word of the agency's action came March 21, in the middle of theAmerican Institute of Ultrasound in Medicine meeting in Baltimore.GE had been eagerly awaiting FDA clearance, and the vendor installedpanels in its booth the next day proclaiming Logiq 700's new regulatorystatus.

Logiq 700 was unveiled at the Radiological Society of NorthAmerica meeting last year and was arguably the most talked-aboutproduct introduction at the conference (SCAN 12/15/93). Some industryobservers saw Logiq 700's introduction as a major gamble, giventhe state of the ultrasound industry in 1993 and its historicantipathy toward products from multimodality vendors.

Logiq 700 may prove the conventional wisdom wrong. GE investedover three years and about $100 million in the system's development.That effort paid off with a scanner that could establish a newpremium tier in the modality. Logiq 700 features an all-digitalbeam former with 128 independent channels. The system's architecturehas been designed to allow upgrading to 256 channels, with thepossibility of 512-channel architecture in the future.

GE must maintain R&D pace. GE's R&D team did not stopwith the 700. At the AIUM meeting, the vendor also displayed Logiq500, a scanner intended to target the mid-tier segment in theU.S. as well as the growing international market. The scanner,which was first shown in January at the International Congressof Radiology in Singapore (SCAN 2/2/94), made its U.S. debut inBaltimore as a works-in-progress.

Logiq 500 was developed by engineers at GE's Japanese subsidiary,GE YMS, working in close coordination with the Logiq 700 R&Dteam in Milwaukee. Logiq 500 will be manufactured by GE YMS inTokyo. GE YMS was formerly known as Yokogawa Medical Systems.

Logiq 500 is a more economical and more portable version ofthe Logiq 700 platform, with 64-channel, all-digital architectureand a size and weight half that of its big brother. Logiq 500will be marketed in the U.S. as a portable mid-tier scanner targetingapplications such as ob/gyn, abdominal, vascular, urological andsmall-parts ultrasound. Logiq 500 has regulatory approval in Japanand Germany and is awaiting FDA 510(k) clearance, according toJohn Kese, general manager of global ultrasound.

Logiq 700 will be marketed primarily in North America, butwill also be sold in other countries where there is demand forpremium ultrasound, according to Kese.

"The 700 is a leadership, high-performance product,"Kese said. "The 500 is focused on an area where economicsis primary."

Both systems will be hooked up to GE's InSite remote serviceprogram.

There is no doubt that the Logiq series is a strong entry thatwill allow GE to quickly capture a respectable market share bysnaring customers attracted to the vendor's reputation as a technologicalleader in other modalities. But GE's potential as a major playerin the modality depends on its ability to keep up with the frenziedpace of technological development that fuels the ultrasound industry.

GE has addressed that problem by structuring its ultrasoundoperation to maximize communication between its parts, accordingto Beth Klein, manager of national ultrasound sales.

"All ultrasound operations are in one location, separatefrom GE headquarters," Klein said. "It's amazing howfast something can happen when there are only feet separatingpeople instead of miles."