Remove 2013 Remove Food and Drug Administration Remove Networking Remove Patients
article thumbnail

Abyrx Receives Additional FDA Clearances for MONTAGE® Settable, Resorbable Bone Putty as Bone Void Filler and Cranial Bone Cement

Legacy MEDSearch

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery.

FDA 52
article thumbnail

Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Small populations, paediatric patients, and the desire from patients and their caregivers to receive active therapy can make the conduct of randomised trials with placebo control untenable.

article thumbnail

XACT Robotics® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit

Legacy MEDSearch

Food and Drug Administration (FDA) clearance, allowing users to robotically insert and steer the XACT ACE® Robotic System remotely from the control room. By providing accurate and actionable results for medical diagnosis, the system aims to enhance early detection and improve patient outcomes. About XACT Robotics®.

FDA 52