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IRIS International Inc.

Medtronic’s Assurant stent, Aspire study win FDA approval | Regulatory Roundup

October 31, 2011 By MassDevice staff Leave a Comment

Medtronic

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.

Filed Under: News Well, Pre-Market Approval (PMA) Tagged With: Apnex Medical Inc., Clinical Trials, cyberonics, Hemosphere Inc., Insulin Management, Investigational Device Exemption (IDE), IRIS International Inc., Regulatory Roundup, Vapotherm

Calgary Scientific’s iPhone app receives FDA clearance | Regulatory Roundup

September 27, 2011 By MassDevice staff Leave a Comment

CalgaryScientific

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Avinger, Calgary Scientific, Eye on the FDA, IRIS International Inc., Regulatory Roundup, Sapheon Inc, Stratatech Corp., uptakemedical

Iris International receives FDA clearance for its NADiA ProsVue prognostic cancer test

September 26, 2011 By MassDevice Leave a Comment

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.

Filed Under: Uncategorized Tagged With: IRIS International Inc.

FDA approves Covidien brain aneurysm treatment | Regulatory roundup

April 6, 2011 By MassDevice staff Leave a Comment

Clearances roundup

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.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Alere, Alphatec, Covidien, CryoLife, Hospira Inc., IRIS International Inc., Philips, Reverse Medical Corp., Spectranetics Corp.

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