this is why basso is so interested in dbmi....
The ComfortScan system has the CE Mark and UL designations, and DOBI
Medical is a certified ISO 9001:2000, ISO 13485:2003 and CAN/US 13485 company.
We currently sell our ComfortScan system to international distributors for
installation at international clinical trial sites. The ComfortScan system is
not yet commercially available in the U.S. as it is limited by U.S. law to
investigational use until approved by the FDA, which cannot be guaranteed. Our
ComfortScan system is also subject to approval by certain foreign regulatory and
safety agencies.
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