In Brief: American Medical Electronics
This article was originally published in The Gray Sheet
Executive Summary
American Medical Electronics: Richardson, Texas-based bone healing products manufacturer receives additional 510(k) clearances from FDA for its Ogden anchor soft tissue reattachment devices. The company says its 7.4 mm anchor, cleared in 1993 for soft tissue reattachment in torn rotator cuffs, has been cleared for "expanded shoulder applications and multiple soft tissue, orthopedic attachment applications in the knee." In addition, AME's 5.5 mm anchor received FDA clearance for use in the shoulder, elbow, wrist, knee, ankle, and foot...
You may also be interested in...
Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line
The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Stakeholders Devise Six-Point Plan To Improve Cross-Border Clinical Trials
Sponsors need guidance on ethics requirements and clarity around national regulations to conduct cross-border clinical trials in the EU, a multi-stakeholder forum says.