FDAnews Device Daily Bulletin

Aware that issuance and closure of devicemaker warning letters are lagging, CDRH recently uncovered 60 “confusing factors” impeding its performance and efforts are underway to weed them out, center officials say.

In an effort at greater transparency, the European Medicines Agency (EMA) has begun publishing public assessment reports (PAR) for ancillary drug substances incorporated in medical devices.

All-metal hip implants, which have been shown to have high failure rates and cause a host of other health problems, were not linked to cancer seven years after implantation, new data show.

The women of Boston’s Healthcare Businesswomen’s Association are acutely aware of the hurdles in healthcare reform, and they’re not going to take them sitting down.

When the FDA warned healthcare practitioners last fall that no flu vaccines had been approved to be administered via jet injection, the companies that spent years developing needleless syringes with this technology suddenly faced a major hurdle.

After promoting circumcision procedures in Papua as a method of AIDS prevention, the Papua AIDS Prevention Commission (KPAD) is introducing a new circumcision device to reduce the risk of HIV infections.

Dune Medical Devices announced results of a study published in the journal Nature.com demonstrating the utility of the MarginProbe technology in prostate cancer surgery.

Medtronic has been assigned a patent (8,262,418) developed by Dale F. Seeley, Spring Park, Minn., and Michael T. Hegland, Mounds View, Mich., for “implantable medical device headers that facilitate device and lead configuration variants.