St. Jude Medical has kept a comparatively low profile in the past couple of months since raising eyebrows with its 'scorched-earth' attack on Medtronic and aggressive defense strategy in relation to its defibrillator leads. But the medical device manufacturer may be unwittingly thrust back in the spotlight in response, thanks to a recently surfaced anonymous report in FDA's MAUDE database detailing an instance of externalized wire in a Durata product. In other news, J&J received regulatory clearance for its much-buzzed-about acquisition of Synthes. Read about these and other top stories in this week's roundup.

• St. Jude's Durata Linked to Case of Externalized Wire (Bloomberg)
• St. Jude Medical Falls 7% on Concerns about Heart Device (Barron's)
• J&J Receives Regulatory Clearance for Synthes Acquisition (Qmed)
• Internal FDA Disputes May Affect Regulatory Outcomes for Medical Devices (MassDevice)
• Why the iPad and Apps are Too Risky for Patients and Developers (MedCity News)
• Women in Medtech: FDA Commissioner Margaret Hamburg (MD+DI)
• Medical Device Design: Defining Innovation and the Power of the First Impression (MPMN)
• BioWorks Event Spotlights Device Industry with Shuren (Memphis Daily News)