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Boston Sci Stent Development Proceeding In-House; J&J Velocity Moves Fast

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific is pursuing the development of its next-generation coronary stent platform internally as well as with partner Medinol as a contingency to the ongoing uncertainties with the Israeli firm.

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LifeScan Defective SureStep Glucose Meter Civil Trial Slated For September

Johnson & Johnson subsidiary LifeScan will remain on probation for a three-year period, during which FDA and the U.S. Probation Office will oversee the firm's documentation of medical device reporting (MDR) complaints.

LifeScan Defective SureStep Glucose Meter Civil Trial Slated For September

Johnson & Johnson subsidiary LifeScan will remain on probation for a three-year period, during which FDA and the U.S. Probation Office will oversee the firm's documentation of medical device reporting (MDR) complaints.

Novoste Meeting With FDA On Beta-Cath Labeling Issues Week Of Oct. 23

Preparations for the U.S. launch of Novoste's Beta-Cath intracoronary radiation catheter system to treat in-stent restenosis are nearly complete, and the firm hopes to receive final FDA approval in time for the American Heart Association meeting in mid-November. The company reported receiving an "approvable" letter from the agency on Oct. 16.

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