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Guidance on using adaptive design in medical device studies issued by FDA

AdvaMed SmartBrief | May 19, 2015

The FDA has released a draft guidance that covers how adaptive design can be properly used in the clinical studies of medical devices. The approach was developed to allow researchers to use data they had gathered to implement changes in clinical trials without affecting the study integrity and validity. Included in the guidance are details about how the approach can be used with devices requiring 510(k) premarket notification or premarket approval, as well as some of the benefits from using adaptive design in medical device trials. MassDevice.com (Boston) (05/18)


Boston Scientific takes part in global diabetes initiative

AdvaMed SmartBrief | May 20, 2015

Funding round pulls in $40M for Shockwave Medical

AdvaMed SmartBrief | May 20, 2015

Medtronic reports positive trial results for antibacterial device

AdvaMed SmartBrief | May 18, 2015

Funding round pulls in $38.9M for Intact Vascular

AdvaMed SmartBrief | May 15, 2015

Financing round boosts Neuronetics' magnetic stimulation device

AdvaMed SmartBrief | May 15, 2015

Advisory panel meets to discuss duodenoscope reprocessing concerns

AdvaMed SmartBrief | May 18, 2015

ConvaTec seeks $1.85B to refinance debts

AdvaMed SmartBrief | May 19, 2015

Smith & Nephew buys S2 Interactive's supply chain management solutions

AdvaMed SmartBrief | May 18, 2015

Traumatic brain injury detector lands FDA clearance

AdvaMed SmartBrief | May 21, 2015


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