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Latest From Medtronic PLC

Guidewire, Catheter Draft Guidance Docs Address Coating Risks

US FDA issued two draft guidelines June 14 addressing labeling and performance testing for guidewires and other interventional vascular devices. The draft recommendations address risks that have been identified in recent years resulting from the separation of coating material from the devices during deployment.

Cardiology Safety

New NEST Subcommittees Include Industry

Medtronic, Cook, BD and J&J are represented, along with academic and US FDA officials, on two new subcommittees formed by the National Evaluation System for health Technology Coordinating Center, which is establishing real-world evidence networks for medical devices.

Clinical Trials Regulation

Class I VAD Units Recalls Continue From Abbott, Medtronic

HeartMate and Medtronic’s HeartWare ventricular assist device platforms have been tagged with class I recalls in the last few weeks based on separate safety issues.

Cardiology Safety

Diversification May Be At Play As Big Pharma Deals With Challenges

Pharmaceuticals have been, and are forecasted to be, the main revenue driver for big pharma, but reliance on this market could shift because of challenges, ranging from generic and biosimilar competition to low R&D productivity. An analysis based on the indicative profit potential metric finds that branded prescription drugs remain the most profitable market to play in, but other sectors may offer opportunities.

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