Paradigm Receives FDA Approval for P60 UBM Device

Paradigm Medical Industries has received FDA 510(k) premarket approval for its P60 ultrasound biomicroscope (UBM) and will begin selling the product in the U.S. immediately.

The UBM is used for viewing structures in the eye involved with glaucoma pathologies and surgical procedures. The P60 represents the company's fourth-generation of UBM devices, and is believed to have better visual clarity and image flexibility than earlier versions.

"Coupled with receiving the CE mark earlier this year, the company can now participate in the global market opportunity for UBM devices," said Paradigm Medical Chief Operating Officer Aziz Mohabbat. The UBM is Paradigm Medical's largest generator of revenues, accounting for more than 25 percent of corporate sales in 2004.