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FDA News

5/23/13 - Covidien Wins FDA 510(k) Clearance for Nellcor Pulse Oximetry Motion Claims [Health & Beauty Close - Up]

Covidien, a global provider of healthcare, announced that its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration 510 clearance for motion claims. According to a release, this makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside puls

5/23/13 - Fitch: Pace of Drug Approvals to Moderate for Global Pharmaceutical Companies [Manufacturing Close - Up]

The U.S. Food and Drug Administration approved 12 new molecular entities in the first quarter of 2013. Fitch expects cancer drugs to lead specialty drug authorizations again in 2013, but new diabetes treatments could be a close second. Fitch notes that the FDA has instituted a new program- breakthrough therapy designation- to expedite the drug appr

5/22/13 - Bausch + Lomb Receives FDA Approval for the TRULIGN Toric Posterior Chamber Intraocular Lens

ENP Newswire- 22 May 2013. Release date- 21052013- ALISO VIEJO, CA.- Bausch+ Lomb, the global eye health company, today announced that it is has received approval from the U.S. Food and Drug Administration for the TRULIGN Toric posterior chamber intraocular lens. Jay Pepose, M.D., Ph.D, of the Pepose Vision Institute in St. Louis, MO, and medical m

5/22/13 - Direct Flow Medical Wins IDE Approval for U.S. SALUS Trial of Transcatheter Aortic Heart Valve System [Health & Beauty Close - Up]

Direct Flow Medical, Inc., a transcatheter heart valve company focused on improving patient outcomes, announced that it has received approval from the United States Food and Drug Administration for an Investigational Device Exemption to begin the SALUS feasibility trial of the Direct Flow Medical Transcatheter Aortic Heart Valve System.

5/22/13 - Perosphere Receives FDA IND Clearance to Initiate Clinical Investigations of the Safety and Efficacy of PER977 to Reverse the Activity of Anticoagulation Therapies including Factor Xa- and IIa-Inhibitors

Perosphere Inc. announced today that it has received U.S. Food and Drug Administration Investigational New Drug clearance to initiate clinical investigations of the safety and efficacy of PER977 to reverse the anticoagulant activity of unfractionated heparin, low molecular weight heparins, fondaparinux, and factor Xa- and IIa-inhibitors.

5/22/13 - Varian Medical Systems Receives FDA 510(k) Clearance of its Nexus DRF Digital X-Ray Imaging System

Varian Medical Systems today announced it received 510 clearance from the U.S. Food and Drug Administration for Varian's diagnostic X-ray image processing workstation that combines radio frequency and digital radiography capabilities on one platform. Varian's Nexus DRF Digital X-Ray Imaging Systemâ?¢ has the ability to interface with a variety of i

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