Cambridge Scientific's bone screw gets FDA 'yes':
This article was originally published in Clinica
Executive Summary
The US FDA has given 510(k) clearance for Cambridge Scientific's orthopaedic WISORB Malleolar bio-absorbable Screw for use in internal fixation of fractures with minimal displacement, such as in the ankle and foot. The partially threaded screw is composed of a bio-absorbable polymer matrix complexed with osteoconductive hydroxyapatite, which promotes bone growth while becoming absorbed as the body heals naturally, says the Cambridge, Massachusetts firm. Data from preclinical studies revealed no implant-related complications for the device, which may also be suitable for treating distal radial fractures, the firm adds.
You may also be interested in...
Sanofi Clinches Key Phase III Immunology Win With Rilzabrutinib
Sanofi’s BTK inhibitor – one of two from its 2021 Principia buy – passed a Phase III test in immune thrombocytopenia as the company focuses on Dupixent-like blockbusters going forward.
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Kahn Says
The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.