FDAnews Device Daily Bulletin

The FDA plans to issue clarifying guidance to address confusion among devicemakers about what exactly constitutes an enhancement and what qualifies as a recall, a CDRH official says.

St. Jude Medical’s Penang, Malaysia, plant received a seven-observation Form 483 at the conclusion of a May 2011 CDRH inspection.

Echometrix has announced it has received FDA clearance for its EchoSoft ultrasound technology, according to a news release.

Mediware Information Systems announced that the 2012 versions of the company’s core blood management software products, including LifeTrak and HCLL Transfusion, have received updated 510(k) clearance by the FDA.

Medtronic is touting positive results from a study of its InterStim sacral nerve stimulator for treating less-severe overactive bladder syndrome, saying the device produces “superior efficacy and quality of life” compared with medication alone.

Med-tech startup Mainstay Medical is moving from Minneapolis to Dublin, Ireland, after closing on a $20 million round of financing led by an Irish venture-capital firm.

Medical-device maker Covidien Plc said Thursday that it will start selling a new patient monitoring system following approvals from the U.S. Food and Drug Administration and a European regulatory agency.

Abbott Laboratories said its Absorb drug-eluting bioresorbable vascular device is now widely available across Europe and parts of Asia Pacific and Latin America.