PreMD Announces FDA Decision On POC Skin Cholesterol Test (Medical News Today)
Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) announced that it has received a non-substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. The company expects to evaluate its options as part of the plans to address this issue.

MAP Pharmaceuticals Reaches Agreement With FDA On Special Protocol Assessment For MAP0004 Phase 3 Clinical Trial In ... (Medical News Today)
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP), an emerging pharmaceutical company, announced that it has completed the special protocol assessment (SPA) process with the U.S. Food and Drug Administration (FDA) for the first Phase 3 clinical trial of its MAP0004 product candidate, and has reached agreement with the Agency on the design of the protocol.

Orthovita Submits 510(k) Application To FDA For The Use Of CORTOSS(R) Bone Augmentation Material In Vertebral ... (Medical News Today)
Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, announced that it has submitted a 510(k) filing to the U.S. Food and Drug Administration for the use of its CORTOSS Bone Augmentation Material in vertebral augmentation. This filing is based on data collected in three U.S.