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FDA, NIH Devise Regulatory Research Agenda, Look For Financing

The sequester is making it difficult to fund new projects, “no matter how high a priority,” National Center for Advancing Translational Sciences Director Christopher Austin noted during a June 25 teleconference to discuss Institute of Medicine recommendations for strengthening the Clinical and Translational Science Awards program.

FDA and the National Center for Advancing Translational Sciences have identified an initial roster of joint research projects but are stymied in moving forward on them by lack of funding.

The sequester “is making it very difficult for us to start anything new, no matter how high a priority it is. We’re trying to figure out which of those agenda...

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• By Marion Webb

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 
• By Natasha Barrow

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.

Medtronic Eyes Up to $350M Tariff Hit in FY26, Leans On Cost Controls And Pricing Strategy

 
• By Shubham Singh

Medtronic expects operating profit to grow approximately 7% in fiscal 2026, excluding tariff impacts. If tariffs materialize at the upper end of the projected range, operating profit growth could drop by 2.2 to 3.2 percentage points.