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The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More
St. Petersburg, Fla.-based Lenstec fielded an FDA Form 483 after “canceling” 15 complaints attributed to user error, rather than closing them. Read More
Retractable Technologies’ device history records do not include a cycle chart for part of the sterilization cycle used by one of the company’s contract sterilizers for 1cc and 3cc VanishPoint syringe product lines, according to a recent Form 483. Read More
The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil. Read More
Medtronic was slapped with a 15-citation warning letter following a preapproval inspection for its MiniMed 530G continuous glucose monitoring system. Read More
FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More
Edwards’ U.S. sales for its Sapien transcatheter heart valve were slightly lower sequentially in the third quarter, a factor that will likely “continue to fuel concerns around the barriers to adoption,” Leerink Swann analyst Danielle Antalffy says. Read More
A Medicare national coverage decision issued Wednesday should spur uptake of Thoratec’s HeartMate II left ventricular assist device at additional cardiac care centers across the U.S., company officials say. Read More
The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court decision that found Synthes’ ’270 spinal implant patent invalid for lack of written description. Read More