The FDA approved a new Medtronic (NYSE:MDT) stent for peripheral arterial disease and green-lighted a pivotal clinical trial of a so-called “artificial pancreas” for Type I diabetics.
The pair of regulatory wins follow a decision that didn’t go Medtronic’s way, after an FDA panel last week recommended against approval of one of its cardiac ablation devices for a type of atrial fibrillation.
Calgary Scientific’s ResolutionMD mobile got a green light from the FDA for viewing diagnostic images on iPhones and iPads.
The ResolutionMD mobile app was built from existing ResolutionMD software, which recieved FDA clearance in 2006. The app already has the greenlight from Canada’s regulatory body, Health Canada and has a CE Mark for distribution in Europe.
IRIS International Receives FDA 510(k) Clearance for Its NADiA ProsVue(TM) Prognostic Cancer Test
CHATSWORTH, Calif., Sept. 22, 2011 (GLOBE NEWSWIRE) — IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables, and a developer of high-value personalized diagnostics tests, today announced that it has received 510(k) clearance from the FDA for its NADiA® ProsVue™ prognostic cancer test.
NADiA ProsVue slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy.
The FDA granted Covidien plc (NYSE:COV) pre-market approval for its brain aneurysm treatment device.
The Mansfield, Mass.-based company designed its new endovascular device, aptly called the Pipeline, to redirect blood flow away from an aneurysm so an embolization can be performed.
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