Direct Flow Medical Inc.
TAVI: Direct Flow to put its valve up against Medtronic’s CoreValve
Direct Flow Medical raises a $32 million in funding round | Medtech funding for the week of December 1, 2014
TAVI: Direct Flow Medical raises $32m, names 1st CCO
Direct Flow Medical said today that it landed a $32 million funding round for its replacement heart valve technology and tapped a 25-year medical device veteran, Chris Richardson, to lead its commercialization program.
LoneStar Heart wins CE Mark approval in EU for hydrogel implant | Regulatory news for the week of October 6, 2014
TAVI: Direct Flow Medical wins CE Mark for enhanced heart valve delivery device
Analyst: Edwards Lifesciences’ Sapien 3 poised to lead TAVI market | MassDevice.com On Call
MASSDEVICE ON CALL — Edwards Lifesciences (NYSE:EW) is poised to take the lead in the transcatheter aortic valve market with its Sapient 3 replacement heart valve, according to Leerink Partners analyst Danielle Antalffy.
FDA grants Philips clearance for 3D TAVI software | Regulatory news for the week of August 25, 2014
Direct Flow wins CE Marks for TAVI device
Direct Flow Medical said today that it won CE Mark approval in the European Union for an additional size of its replacement heart valve, plus an EU OK for the use of the devices without contrast media.
TAVI: FDA OKs Direct Flow Medical’s U.S. pivotal trial for heart valve
Direct Flow Medical said the FDA granted an investigational device exemption for a U.S. pivotal trial for its transcatheter aortic valve implant.
TAVI: Direct Flow lands $50M through debt financing
California-based medtech company Direct Flow Medical landed $50 million in debt financing, planning on using the new funds to support commercialization of a new transcatheter aortic valve implantation system.