Tag: CathWorks

CathWorks FFRangio™ System Receives Regulatory Approval in Japan

KFAR-SABA, Israel and ALISO VIEJO, Calif., Dec. 11, 2019 /PRNewswire/ — CathWorks today announced the approval of The CathWorks FFRangio™ System by the Japan’s Ministry of Health, Labour and Welfare (MHLW). The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images […]

CathWorks Appoints Chief Financial Officer

KFAR-SABA, ISRAEL & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced that Mike Feher has joined CathWorks as Vice President of Finance and Chief Financial Officer. His appointment coincides with US commercialization of the CathWorks FFRangio™ System. Mr. Feher will initially focus on the development of financial and operational capabilities, as well as creating […]

CathWorks Adds Vice President of Global Marketing to Leadership Team

KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced that Ramin Mousavi has joined CathWorks as Vice President of Global Marketing & Strategy. Mr. Mousavi, an experienced cardiovascular marketer, will take responsibility for the CathWorks FFRangio™ System U.S. clinical and commercial launch and direct future expansion into other global markets. Mr. Mousavi […]

CathWorks Names Paul Kapsner as Vice-President of Sales

KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced that Paul Kapsner has been named as Global Vice President of Sales. His appointment coincides with recent United States FDA clearance of the company’s CathWorks FFRangio™ System. His initial focus will be on accelerating the clinical and commercial organization in the United States. […]

CathWorks FFRangio™ System Receives U.S. FDA Clearance

KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced today that its FFRangio™ System received United States Food & Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial […]

CathWorks FFRangio™ Trial Meets Primary Endpoint and Exceeds Performance Goals

KFAR-SABA, Israel–(BUSINESS WIRE)–The journal Circulation published results from the CathWorks FFRangio™ FAST-FFR clinical trial in an article titled Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. The publication and trial results were announced today at the 2018 TCT (Transcatheter Cardiovascular Therapeutics) annual meeting in San Diego, California. The FAST-FFR trial demonstrated that the […]

FAST-FFR Pivotal Trial Added to TCT 2018 Late-Breaking Clinical Trial Program

KFAR-SABA, Israel–(BUSINESS WIRE)–CathWorks announced that the FAST-FFR pivotal trial has been added to the late-breaking clinical science program during the 2018 TCT (Transcatheter Cardiovascular Therapeutics) annual meeting in San Diego. FAST-FFR trial data will be presented in the Main Arena during the late-breaking science session that begins at 12 noon […]

CathWorks FFRangio™ System Files FDA 510(k) Submission

KFAR-SABA, Israel–(BUSINESS WIRE)–CathWorks announced that it has submitted its CathWorks FFRangio™ System to the United States Food & Drug Administration (FDA) for review and 510(k) market clearance. The CathWorks FFRangio System is the non-invasive FFR platform that quickly and precisely delivers objective multi-vessel physiologic measurements to cost-effectively optimize and confirm intraprocedural PCI […]

CathWorks FAST-FFR Trial Enrollment Completed Early

KFAR-SABA, Israel–(BUSINESS WIRE)–CathWorks announced that its FAST-FFR trial is fully enrolled ahead of schedule. The trial is designed to evaluate efficacy of the CathWorks FFRangio™ System in terms of sensitivity and specificity when compared to conventional invasive Fractional Flow Reserve (FFR). Enrollment in the trial began on September 27, 2017 and […]