Stryker receives first FDA expanded indication for Trevo following stroke guideline update
Stryker Corp. won FDA approval for expanded indication of its Trevo Retriever device for frontline treatment of patients with acute ischemic stroke, widening the time window for the clot removal device from six to 24 hours. The FDA nod followed a change in stroke guidelines issued in late January by the American Heart Association (AHA) and American Stroke Association (ASA) to allow for the longer recommended treatment period thereby increasing the of patients who would undergo clot removal, or thrombectomy.
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.