FDAnews Device Daily Bulletin

An optical supplies manufacturer has received an FDA warning letter for nine violations, most relating to complaint handling, device design and process control procedures.

As Canadian healthcare facilities begin to insist on credentialing of medical device sales reps, industry stakeholders are offering advice on vendor credentialing policies to avoid issues that have plagued U.S. organizations.

In May of 2010 Joan Greffrath of Worcester received a life-changing diagnosis.

Greatbatch announced the company will establish an Active Implantable Medical Device Research and Development Center in Singapore.

Cynosure said it has received U.S. regulatory clearance for a home-use over the counter device to treat facial wrinkles.

It looks like you’re riding a bicycle while you’re lying on your back on a padded bench, and for someone with Parkinson’s or multiple sclerosis, restoring movement could be a dream.

Teleflex announced it has acquired Hotspur Technologies.

Roche announced today it has received clearance from the FDA for the Accu-Chek Combo system for insulin pump therapy.