Becton, Dickinson and Co. (BD) closed enrollment of its Lutonix 014 drug coated balloon (DCB) trial for treatment of patients with critical limb ischemia (CLI) and claudication due to below-the-knee (BTK) stenotic or occluded arterial lesions. Research is intended to support premarket approval, which the firm is expected to apply for late this year. Lutonix was initially developed under C.R. Bard Inc., which was acquired by BD in 2017.
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.
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.
Medtronic plc expanded its neurovascular offerings with FDA approval of the Riptide aspiration system aimed at patients with acute ischemic stroke. The system is delivered through the Arc catheter, is inserted via leg incision, and is used to extract a blood clot and ultimately restore normal blood flow to the brain.
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.
