People In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA device deputy: Christy Foreman officially assumes the position of deputy office director for science and regulatory policy in CDRH's Office of Device Evaluation Nov. 7 after serving as acting science deputy since June. Foreman, a longtime FDA staffer who has worked on both the pre-market and post-market sides of CDRH, will oversee ODE's guidance, 513(g) request and de novo review programs, and serve as a liaison to the Office of Science and Engineering Laboratories and the Office of Compliance. ODE's clinical deputy director spot has yet to be permanently filled after Aron Yustein left in March, FDA said. Markham Luke, a Center for Drug Evaluation and Research reviewer and dermatologist, is currently acting in the clinical deputy director role
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Financings In Brief
ATS Medical raises settlement funds: Heart valve manufacturer raises $20 million through the sale of 8.5 million shares of its common stock at $2.35 each, plus warrants to buy 2.5 million more shares at various prices, to venture capital firm Essex Woodlands Health Ventures. A portion of the proceeds will be used to settle a 2007 lawsuit filed by Carbomedics over a mechanical heart valve component supply agreement. The settlement, announced in conjunction with the financing on Dec. 22, will enable ATS to continue to make and sell its Open Pivot mechanical heart valve in exchange for a $3 million payment to Carbomedics on Dec. 29, 2008, and an additional $4.5 million on April 30, 2009
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.