FDA to hold OB/GYN committee meeting
The FDA will hold a meeting of a public advisory committee May 16, 2008, at the Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, Maryland.
The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will discuss, make recommendations, and vote on a premarket approval application for the FC2 Female Condom, sponsored by the Female Health Co. (). This device is indicated to help prevent HIV/AIDS and unintended pregnancy.
For information, contact Michael Bailey, Center for Devices and Radiological Health (HFZ-470), FDA, 9200 Corporate Blvd., Rockville, MD 20850; phone 240-276-4100, or FDA Advisory Committee Information Line, 1-800-741-8138.
'Going concern' report for CryoCor
CryoCor (San Diego) said that its annual report on Form 10-K included an audit opinion with a "going-concern" qualification, a statement by CryoCor's independent registered public accounting firm expressing substantial doubt, based upon current financial resources, as to whether CryoCor can continue to meet its obligations beyond 2008 without access to additional working capital.
In its Annual Report on Form 10-K, CryoCor indicated that its working capital balance at Dec. 31, 2007 and the expected collection of $4.0 million from its collaboration with Boston Scientific, would be sufficient to meet its anticipated cash requirements until the fourth quarter of 2008.
CryoCor is a medical technology company that makes a disposable catheter system based on its proprietary cryoablation technology for the minimally invasive treatment of cardiac arrhythmias.