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VeraLight Inc.

St. Jude enrolls first patient into heart rhythm early intervention trial | Regulatory Roundup

August 2, 2011 By MassDevice staff Leave a Comment

St. Jude

St. Jude Medical Inc. (NYSE:STJ) enrolled the first patient into its pan-European study of early interventions of irregular heartbeat.

St. Jude can enroll more than 3,000 patients across 200 centers in Europe, including locations in Belgium, the Czech Republic, Denmark, France, Germany, Italy, the Netherlands, Poland, Spain, Switzerland and the United Kingdom.

Filed Under: News Well Tagged With: Abbott, Apnex Medical Inc., Clinical Trials, Entra Health Systems, Intelligent Medical Devices Inc., MindFrame Inc., Mirador Biomedical Inc., Regulatory Roundup, Sorin Group, stjudemedical, Telcare Inc., Valeritas, VeraLight Inc.

FDA clears Biomet’s hip implant | Regulatory roundup

April 27, 2011 By MassDevice staff Leave a Comment

Clearances roundup

Biomet Inc. received FDA 510(k) clearance for its new hip replacement device.

Warsaw, Ind.-based company said its Active Articulation E1 dual mobility hip system is an implant option for orthopedic surgeons performing hip replacement surgery.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Biomet, Biotronik, Guided Therapeutics Inc., MedShape Solutions Inc., Reverse Medical Corp., SiBone, Varian Medical Systems, VeraLight Inc.

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