FDA clears a 7D Surgical 510(k) for itsMachine-vision Image Guided Surgery system for spine surgery.
FDA Review posts the Federal Register notices for the week ending 1/20/2017.
An FDAlawblog.com analysis of recent enforcement letters and new guidance documents issued this month on product communications finds a dramatic enfor...
FDA clears an OssDsign 510(k) for the OssDsign Cranial PSI, a patient-specific medical implant intended for reconstruction of cranial defects (craniop...
FDA clears a Bone Index Ltd. 510(k) for its second generation Bindex point-of-care device model to help in osteoporosis diagnosis.
In his last role as FDA commissioner, Robert Califf pens a JAMA online article calling for a harmonized risk-benefit assessment across the medical pro...
FDA approves a Synergy Pharmaceuticals NDA for Trulance (plecanatide) for treating adults with chronic idiopathic constipation.