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Direct Flow Medical Secures CE Mark For TAVR Device

This article was originally published in The Gray Sheet

Executive Summary

Direct Flow Medical announced Jan. 28 the receipt of a CE mark for its transcatheter aortic heart valve system, to compete with Edwards, Medtronic among others in burgeoning market.

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Lotus Launches In Europe: Boston Scientific Joins Crowded TAVR Field

The firm announced the CE mark and European launch of its transcatheter aortic heart valve replacement device Oct. 28. Boston is one of at least seven firms with a TAVR device now on the market in Europe.

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Rep. Leonard Lance reintroduced a bill in the House to address flaws in Medicare’s reimbursement system for diagnostics. Guided Therapeutics receives more questions from FDA on the PMA for its LuViva cervical scan. Study news from InSightec, Direct Flow Medical and PLC Systems. More news.

JenaValve Raises $62.5 Million To Fund Transfemoral TAVI Trial And More

Funds will help the German company continue developing its JenaValve transcatheter aortic valve, including a new clinical trial of the transfemoral version of the system.

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