N.C. group to hold medical device forum
The North Carolina Medical Device Organization (NCMD; Research Triangle Park, North Carolina) is hosting three FDA speakers who will discuss issues such as submission best practices, new guidance, and dispute resolution.
The forum, "FDA Regulatory Update," will be held May 16 from 4:30-8 p.m. at the North Carolina Biotechnology Center. The panel also will include a regulatory submission perspective from a local medical device firm.
Panelists include Patricia Love, associate director of the FDA's Office of Combination Products; Heather Rosecrans, director of 510(k) staff in the FDA's Center for Devices and Radiological Health; Les Weinstein, CDRH ombudsman; Tammy Carrea, director, regulatory affairs, Sicel Technologies; and Dan Pelak, president and CEO, Closure Medical, who will serve as moderator.
NCMD is a nonprofit cluster organization sponsored by the North Carolina Bioscience Organization. NCMD serves a broad sector of the medical device and diagnostic industry, including research, development and manufacturing firms; suppliers; service companies; hospitals; clinics and educational institutions.
Nasdaq to look at 10-K filing
Applied Imaging (San Jose, California) said that Nasdaq notified the company that, in rendering a determination regarding the company's continued listing on the Nasdaq SmallCap Market, it will consider its delinquency in the filing of its annual report on Form 10-K for the fiscal year ended Dec. 31, 2004, with the Securities and Exchange Commission.
On March 1, the company filed with the SEC its Form 10-Q for the quarter ended Sept. 30, 2004, and the restatement of its 2003 and 2002 annual financial results and March 31, 2004, and June 30, 2004, quarterly financial results.
Since then, the company has been working on completing its financial close and its Form 10-K for the fiscal year ended Dec. 31, 2004. It released its financial results for that year on April 18 and said it expects to file its Form 10-K for that period this week.
Applied Imaging is a supplier of automated imaging systems utilized in genetics and pathology laboratories for the analysis of chromosomes in cancer and prenatal disorders.