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OSI Systems Inc.

Abbott wins Xience Prime nod in Japan | Regulatory Roundup

April 9, 2012 By MassDevice staff Leave a Comment

Abbott

Abbott (NYSE:ABT) said it won approval from the Japanese Ministry of Health, Labor and Welfare for its next-generation Xience Prime coronary stent

The nod means the cobalt-chromium stent is "available in all of the major markets worldwide," according to a press releaase, including the U.S., Europe, China and India.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: Abbott, Arteriocyte, C8 Medisensors, Investigational Device Exemption (IDE), OSI Systems Inc., Regulatory Roundup, SastoMed GmbH, Teleflex

GPOs: Novation and Premier tout new deals

October 18, 2011 By MassDevice staff Leave a Comment

Novation
Premier

Hospital group purchasing organizations Novation and Premier signed new contracts this week, covering patient monitoring solutions, intra-aortic balloon catheters and pumps.

Novation awarded a three-year contract to Spacelabs Healthcare, a subsidiary of OSI Systems Inc. (NSDQ:OSIS), for patient monitoring and connectivity solutions.

Filed Under: Catheters, News Well, Patient Monitoring Tagged With: Arrow International, Deals Roundup, Novation, OSI Systems Inc., Premier Inc., Spacelabs Healthcare, Teleflex

FDA: Aethlon can sell unapproved blood filter in India | Regulatory roundup

March 8, 2011 By MassDevice staff Leave a Comment

Clearances roundup

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Aethlon Medical Inc., Gift Bans, Guided Therapeutics Inc., Henry Schein Inc., OSI Systems Inc., wrightmedical

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