Micro-ultrasound system receives 510(k) clearance
The FDA has awarded 510(k) clearance to ExactVu, a micro-ultrasound system from Exact Imaging. The product, a disruptive prostate micro-imaging and biopsy system, can provide urologists with real-time imaging and biopsy guidance of the prostate. It represents a 300% improvement in imaging resolution–resolution can be scaled down 70 microns (or 0.07 of a millimeter)–compared to traditional urologic ultrasound systems, according to Exact Imaging. The product is designed to facilitate the detailed interrogation and visualization of suspicious regions and perform targeted prostate biopsies, the company says.
For more information, visit www.exactimaging.com.