Nov. 21, 2017

Editor’s Note

In observance of the Thanksgiving holiday, The Daily Buzz will not be published Thursday, Nov. 23, or Friday, Nov. 24. The next issue will be published Monday, Nov. 27. Read More

FDA Says Osteotech Must Improve Aseptic Processing, Investigations

The agency found that the material used to stopper bottles under vacuum and for lyophilization of soft tissue was not tested for microorganisms. Read More

FDA Raps ADB Interest For Lack of CAPA, MDR Procedures

The agency identified more than 70 MDR-reportable complaints, but the company could not produce files to show the results of investigations. Read More

FDA Clears Drug Coated Catheter for Marketing

The balloon is coated on its outer surface with the drug paclitaxel to help prevent the vessels from narrowing again. Read More

First Telehealth Feature for Cochlear Implants Snags FDA Approval

The agency evaluated patient self-assessment data and assessed the feature’s cybersecurity measures. Read More