3-D ultrasound scanner awaits U.S. clearanceKorean ultrasound manufacturer Medison has purchased a 60% interestin Austrian 3-D ultrasound developer Kretztechnik AG. The purchaseshould give Kretztechnik the staying power to weather what hasbeen
Korean ultrasound manufacturer Medison has purchased a 60% interestin Austrian 3-D ultrasound developer Kretztechnik AG. The purchaseshould give Kretztechnik the staying power to weather what hasbeen an agonizingly long 510(k) review process in the U.S. forits 3-D technology.
Kretztechnik was formed in 1947 and was one of the first ultrasounddevelopers. The company got a head start in 3-D ultrasound withits Combison 330 scanner, which integrated 3-D technology intoan ultrasound system. Other non-3-D Kretztechnik scanners includethe gray-scale Combison 311 and the color Doppler Combison 420.
Combison 311 is distributed in the U.S. by Cone Instruments ofSolon, OH, which also has rights to the 3-D system. The companieshad hoped that Food and Drug Administration clearance of Combison330 would be forthcoming in 1990 (SCAN 5/9/90). Kretztechnik latermade substantial changes to the technology, renamed the new systemCombison 530, and submitted a new 510(k) application to the FDAin 1994.
Two years later, Cone and Kretztechnik are still waiting for theagency's go-ahead on Combison 530. In the meantime, other ultrasoundcompetitors, such as Acoustic Imaging and TomTec, have receivedclearance for dedicated 3-D workstations. In addition, major ultrasoundvendors like ATL and Toshiba have developed 3-D ultrasound technologythat can be used with their conventionalscanners.
Perhaps due in part to the lack of U.S. sales for Combison 530,Kretztechnik ran into financial difficulties as sales and R&Dcosts increased, according to a Medison spokesperson. It beganlooking for a corporate partner in July 1995 and settled on Medisonbecause of that company's ultrasound manufacturing experienceand European marketing channels, the spokesperson said.
The companies declined to disclose financial terms of the purchase,which was completed last month. Medison plans to sell Kretztechniksystems through dealers, and is evaluating the company's currentdealer network, according to Mark Hayward, president of MedisonAmerica. It would like to maintain a relationship with Cone inthe U.S.
"Medison is going through a standard process of evaluatingdealers around the world," Hayward said. "
What Medison and Medison America are trying to do is cooperatein some way with Cone for U.S. distribution."