CathWorks Submits FFRangio System to FDA for Review and Clearance

August 31, 2018—Israel-based CathWorks Ltd. announced that it has submitted its noninvasive fractional flow reserve (FFR) platform, the FFRangio system, to the FDA for review and 510(k) market clearance in the United States. The company expects to receive clearance by the end of 2018.

The FFRangio system is designed to quickly and precisely deliver objective multivessel physiologic measurements to cost-effectively optimize and confirm intraprocedural percutaneous coronary intervention therapy decisions.

The company stated that the submission was made possible with the early completion of full enrollment of the FAST-FFR trial, which was announced on August 16.

The FFRangio system is in development and is not yet FDA cleared or available for sale in the United States, advised the company.