Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
W.L. Gore & Associates
AGA Medical alleges Gore patent infringement
AGA Medical Holdings Inc. (NSDQ:AGAM) filed a lawsuit against W.L. Gore & Associates alleging that the Newark, Del.-based company is infringing on a patent for its transcatheter occlusion device for heart defect treatment.
In a lawsuit filed in the U.S. District Court for Minnesota, AGA Medical alleges that Gore’s Helex Septal Occluder device employs technology covered by five claims in its patent for "Percutaneous Catheter Directed Constructing Occlusion Device."