A leader in the low- to mid-field MRI market, Hitachi Medical Systems America of Twinsburg, OH, is laying plans to enter the highly competitive U.S. multislice CT arena next year. The company recently received FDA 510(k) clearance for a single-slice scanner as part of its plan to introduce a multislice system later on.
HMSA hopes to fill the void left by Hitachi's former CT partner Philips Medical Systems North America of Bothell, WA. Hitachi and Philips had a longstanding relationship in the U.S. in the modality, with Philips selling scanners manufactured by Hitachi Medical Corp. in Japan. The partnership ended in 2001 when Philips bought Marconi Medical Systems, a company that already had a robust CT product line.
HMSA’s entry into the CT market could simplify Hitachi’s distribution network in the U.S. for its medical imaging products. Hitachi formed HMSA in 1989 as a joint venture with Summit World Trade to sell open MRI scanners in the U.S. HMSA was unable to sell CT systems, however, because the Philips relationship was already in place, according to Bill Bishop, HMSA’s director of business development.
"The game plan is that we will be in the CT market with a multislice system sometime in the next year," Bishop said, adding that the first scanners will be sold in Japan.
Although HMSA won’t say how many of its CT machines Philips installed each year, Philips sold more of these scanners in Europe than in the U.S. Hitachi is hoping that the HMSA relationship will help it strengthen its CT profile in North America.
Hitachi initially submitted a 510(k) clearance for its single-slice Pronto scanner, which Hitachi Medical Corp. has been marketing in Japan, China, and Southern Asia. But since filing the application, HMSA has decided not to market the system in the U.S. due to the weakness of the single-slice market.
The single-slice Pronto was cleared last month, and even though it won’t be sold in the U.S., the approval will help Hitachi as it prepares a 510(k) submission for its upcoming multislice product. Hitachi will be able to use Pronto as a predicate device on the multislice application, according to Bishop.
HMSA has no CT customer base in North America, but it does have a large MR customer base, which is important in this era of multimodality companies. Bishop said it's still too early to provide details on Hitachi’s multislice technology or its distribution plans.
The CT initiative would be the second new modality that HMSA has added to its product portfolio lately as it seeks to expand from its beachhead in MRI. The company late last year signed an agreement to sell PET cameras manufactured by CTI PET Systems of Knoxville, TN.
Bishop believes that HMSA’s strong track record and installed base in MRI will give it a foot in the door for both PET and multislice CT sales.
"We wouldn’t introduce a CT system if we didn’t have a good customer base out there that we could sell to," Bishop said. "We have customers calling us (saying) they would like to buy a CT or PET system from us because they have had good experience with MRI. That gives us a unique distribution channel."
By Robert BruceAuntMinnie.com contributing writer
May 1, 2002
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