Acuson gets 510(k) for contrast harmonics

Ultrasound vendor Acuson rounded out its harmonic imaging program with Food and Drug Administration 510(k) clearance for contrast imaging with the vendor's Native Tissue Harmonic Imaging (NTHI) technique, which was originally released last year for noncontrast imaging. The contrast agent imaging capability relies on the NTHI technology and does not require any additional software, according to the Mountain View, CA-based vendor.

NTHI transmits lower frequency sound waves to improve penetration, while receiving and processing only higher frequency echoes produced by the body's inherent harmonic characteristics, according to the firm (SCAN 6/25/97). Since ultrasound contrast agents yield harmonic signals of greater strength than the signals generated by NTHI, the task of imaging the agents is an easy one for Acuson scanners equipped with the technology, according to John Davidson, cardiology marketing manager for Acuson.

Acuson worked with several ultrasound contrast companies, more than 10 contrast agents, and multiple reference sites to test the contrast agent capability. In researching the technique, the company discovered that while a dedicated contrast package may be required for R&D contrast applications, NTHI was more than sufficient for routine clinical use of contrast imaging, Davidson said. Acuson will release a dedicated package designed for research applications by the end of this year, and will continue to refine the technique as more clinical indications for contrast agents become apparent, he said.

Available on both the Sequoia C256 echocardiography scanner and the Sequoia radiology version, NTHI is expected to be migrated to Aspen by July. The option will cost $35,000.