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J&J Appeals FDA "Not-Approvable" Letter For Sedasys Sedation System

This article was originally published in The Pink Sheet Daily

Executive Summary

Sedasys was recommended for approval, with conditions, by FDA's Anesthesiology and Respiratory Therapy Devices panel in an 8-2 vote last May, but FDA is not required to follow advisory panel recommendations.

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Kinetic Concepts to retain therapeutic support systems biz: Kinetic Concepts says it will retain its formerly struggling Therapeutic Support Systems (TSS) business, which rebounded with 7% sales growth to $82.7 million in the fourth quarter of 2009, the firm reported Jan. 26. The firm initiated a review of the TSS business last fall after a third-quarter TSS sales drop of 10% (1"The Gray Sheet" Nov. 16, 2009). The fourth-quarter TSS results "suggest that the hospital environment is stabilizing after a tumultuous year," said CEO Catherine Burzik. The unit includes items such as hospital beds for wound care, bariatric and critical care patients. "After careful review, we have concluded that retaining this important business serves the best interest of our stakeholders," Burzik said. Corporate fourth-quarter revenue of $526.8 million was up 7% from last year (or 4% at constant currency). Kinetic Concepts notes that its long-standing U.S. negative pressure wound therapy (NPWT) patent case against competitor Smith & Nephew is on track for a February trial. A Japan launch of its V.A.C. Therapy technology for NPWT remains on deck for the second quarter of 2010. And the company plans to expand its European sales force from 26 to 35 reps by the end of March

J&J’s Computer-Assisted Sedation System Gets FDA Panel Nod

Ethicon Endo-Surgery's Sedasys computer-assisted personalized sedation system should be approved by FDA, as long as labeling requires a three-person team to be present during its use, according to the agency's Anesthesiology and Respiratory Therapy Devices panel

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