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FDA clears Navilas 577s
The FDA has granted 510(k) clearance for the Navilas Laser System 577s, a compact, all-digital system for navigated focal and peripheral laser treatments, making it immediately available in the U.S., according to correspondence from OD-OS, the system’s manufacturer.The Navilas 577s system allows pre-planning of laser therapy using fundus images and external diagnostic images, according to the correspondence. The laser photocoagulation tool gives a “more precise and complete treatment in a compact and affordable package,” founder and chief executive officer of OD-OS Winfried Teiwes, PhD, said in the correspondence.