FDAnews Device Daily Bulletin

A pair of FDA final guidances may make it easier for companies to gain approval of devices that use computer software to analyze data gathered during radiology.

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.

The Food and Drug Administration is investigating how a document-management company inadvertently made public some 75,000 pages of confidential agency files about the approval of medical devices, FDA officials said.

The Food and Drug Administration’s secret monitoring of its staff raised hackles in Congress on Sunday after lawmakers learned their own offices were apparently targeted by the surveillance operation.

St. Jude Medical said early results from the Riata lead evaluation study indicate externalized conductors occur less frequently in thinner leads and the rates were consistent with other published studies.

TriReme Medical announced that it has received FDA clearance for an expanded matrix of sizes for its unique Glider PTCA balloon catheter.

Queen’s University has teamed up with a medical imaging company in a venture that has the potential to revolutionize cancer detection and treatment.

MediPurpose, a medical product manufacturer and master distributor, announced that it has been granted trademark protection in Australia for its MediPlus advanced wound care products logo and brand identity.