Colibri Heart Valve begins enrollment for faster, easier 'dry tissue' TAVI device
Private company Colibri Heart Valve LLC reported the first two enrollees in the clinical early feasibility study of its second-generation expandable 24 mm and 27 mm transcatheter aortic valve (TAVI) system. The "package-to-patient" device has built on the earlier system that included a premounted, replacement aortic heart valve already precrimped to the balloon catheter, sheathed and sterilized so that it can be used directly from packaging. The newest device allows for adoption by additional patients, such as those with bicuspid aortic valves.
Foundation and Pfizer partner to develop tumor companion diagnostics for CGP assay
Foundation Medicine Inc. has struck up a partnership with Pfizer Inc. to develop and eventually market companion diagnostics (Cdx) for its comprehensive genomic profiling (CGP) assay, Foundationone Cdx. FDA-approved Foundationone Cdx provides genomic profiles and incorporates additional diagnostic information on solid tumors. The test detects alterations to EGFR, ALK, BRAF, ERBB2, KRAS, NRAS and BRCA1/2 genes.
Med-tech venture investment calls for creativity
SAN FRANCISCO While med-tech investment hit a low point about five to 10 years ago, venture firms are once again interested in the channel, though investments have taken on a different look than previously, according to a panel at the Redefining Early Stage Investment (RESI) meeting.