The EU Medical Device Regulation

The EU Medical Device Regulation

Medtronic made a minority investment in CathWorks in 2018, positioning it to monitor the progress of the Israeli startup. The U.S. Food and Drug Administration granted 510(k) clearance to FFRangio late in 2018. Later, CathWorks raised $60 million across series C and series D financing rounds and received approval and national reimbursement in Japan.

Having seen CathWorks’ progress, Medtronic has tightened its ties to the startup, upping its investment in the company and immediately stepping in to co-promote FFRangio in the markets where it is available commercially. The deal ends CathWorks’ search for a partner.

“CathWorks has been looking for the right partner to help us expand the reach of the FFRangio system globally,” CathWorks CEO Ramin Mousavi said in a statement. “Medtronic not only brings the strength of its commercial team to CathWorks, but a reputation of investing and defining new opportunities to revolutionize care.” 

For Medtronic, the deal presents a way to strengthen its cardiovascular portfolio. CathWorks pitches its technology as a tool that combines angiograms and computational science to support coronary artery disease decisions, for example by showing where fractional flow reserve drops occur. In a pooled analysis of five studies, FFRangio achieved a sensitivity of 91% and a specificity of 94%.

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