FDA schedules ob/gyn panel
This article was originally published in The Gray Sheet
Executive Summary
Female Health's PMA for the FC2 second generation female condom will go before FDA's Obstetrics and Gynecology Devices advisory panel May 16, the agency announces March 27 in the Federal Register. The firm's first-generation FC is the only product for women approved by FDA that provides dual protection against unintended pregnancy and sexually transmitted diseases, according to Female Health. The second-generation device is made of nitrile while the FC is made of polyurethane
You may also be interested in...
OB/GYN panel meeting
FDA's Obstetrics and Gynecology devices panel will meet Dec. 11 in Gaithersburg, Md. to vote on Female Health's PMA for its FC2 second-generation female condom, indicated for dual protection against unintended pregnancy and sexually transmitted diseases (1"The Gray Sheet" March 31, 2008, In Brief). A previously scheduled May 16 meeting was postponed
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.
Finance Watch: Canaan, Regeneron Reveal New Funds For Start-Ups
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to $1bn-plus. Also, incubators plan to grow over the next decade and in recent financings Avenzo raised $150m and Nvelop launched with $100m.